Clinical Research Coordinator

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Clinical Research Assoc I

  • Job Id JD2877281
  • Industry Not mentioned
  • Total Positions 1
  • Job Type: Full Time
  • Salary: Not mentioned
  • Employment Status Permanent
  • Job Location Pune, Maharashtra, India
  • Education Not mentioned
  • Experience Year

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15 Clinical research Jobs in Pune

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Clinical Research jobs in Pune

Senior clinical research associate - remote.

Lifelancer Pune

About the role:The Clinical Operations group is responsible for site management, monitoring tasks and support of clinical trials. The group allocates resources to projects as appropriate to assist with the implementation of project plans and to ensure compliance with regulatory requirements and Standard Operating Procedures.Key Accountabilities:Coordinate the identification, feasibility...

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Artificial Intelligence Researcher - Clinical Data Management

SOLVEXIS CONSULTING PRIVATE LIMITED Pune

We're Hiring : AI Researcher Job Location : Pune Are you passionate about leveraging cutting-edge AI technologies to drive innovation in healthcare? Join our team as an AI Researcher and be part of a dynamic environment where your expertise in Generative AI will shape the future of clinical decision-making. Job Description : As an AI Researcher specializing in Generative AI applications for...

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Artificial Intelligence Researcher - LLM Models

Solvexis Consulting Private Limited Pune

Job Description : Join our dynamic team where you'll be at the forefront of transforming business through advanced AI technologies. As an AI Engineer specializing in Generative AI applications for clinical data, you will play a pivotal role in developing innovative solutions that leverage cutting-edge Large Language Models (LLMs) to revolutionize clinical business decision-making. Your expertise...

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Content Curator

ACS International India Pvt. Ltd. (ACSII) Pune

ACS-I India is looking for a Curation Expert who will be responsible for extracting, analyzing, and curating complex biological information from various life science domains such as medicinal chemistry, biology, genomics, proteomics, and clinical trials, from scientific literature and patents. You will collaborate with other biocurators to ensure comprehensive coverage and data quality. Your...

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Orthotist - Product Development

Frido Pune

Company Description Frido specializes in building innovative products to enhance everyday activities such as walking, sitting, and sleeping. Our award-winning products, including wheelchairs, shoe inserts, and seat cushions, have earned both Amazon's Choice and Bestseller tags in the Indian market. Our mission is to enable people to lead pain-free lives and equip them with the freedom to do more...

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Dental Product Specialist

scanO Pune

Job Summary: The Dental Product Specialist plays a critical role in the sales and distribution of scanO air (AI Robot) by providing deep product knowledge, driving sales efforts, and ensuring customer satisfaction. This individual will serve as a bridge between the business operations team and clients, ensuring seamless integration of scanO air into dental practices. Key Responsibilities: -...

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Associate Manager (LM), PSS

CSS Fortrea Scientific Pvt Ltd Pune

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90...

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Enterprise Architect – Hosting Services

MUM Fortrea Development India Pvt Ltd Pune

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90...

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Supervisor, Data Analyst

Precision Medicine Group Pune

Global trials for oncology, rare diseases and other complex diseases face unique challenges. Precision partners with our clients to meet them head-on through our extensive footprint across the globe. We succeed by pairing personalized clinical services with translational medicine excellence, making us the first fully integrated clinical research organization created expressly to help advance the...

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Principal Consultant- Argus Drug Safety Migration expert

Pune

Job Description `Overview of the OrganizationOracle Life Sciences GIU (LSGIU) provides industry leading solution to Life Sciences organizations including pharmaceutical companies, CROs (Contract research Organizations), Academic research and Healthcare providers that include care providers, IDN (integrated delivery networks), public regional/national healthcare organizations. The portfolio of...

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Clinical data associate ii remote.

Lifelancer Pune

About the jobDescriptionClinical Data Associate IISyneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.Our Clinical Development model brings the customer and the patient to the center of everything that we do....

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Frido Pune

Title: Research Podiatrist Job Description: We are seeking a dedicated and experienced Podiatrist to join our Research and Development team. The ideal candidate will be responsible for conducting research, developing new concepts, and contributing to the advancement of podiatric products and services. Responsibilities: 1. Conduct and analyze clinical research in the field of podiatry. 2....

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Clinical trial assistant.

Lifelancer Pune

About the jobJob Overview:Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery.Essential Functions:Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g.,...

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clinical research coordinator jobs in pune

Clinical VBA Developer - REMOTE

Lifelancer Pune

About the jobPrimary Skill: Clinical VBA DeveloperYears of Experience: 5+ yearsJob Location: RemoteMust Have Skills: VBA, SQL, Clinical Research ProcessJob description :Design systems, including development and maintenance to support deliverables.Design, development, documentation, and quality assurance of new systems.Defining technical requirements, database structure and database...

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Senior Clinical Research Associate - REMOTE - Apply

Lifelancer Pune

About the role: The Clinical Operations group is responsible for site management, monitoring tasks and support of clinical trials. The group allocates resources to projects as appropriate to assist with the implementation of project plans and to ensure compliance with regulatory requirements and Standard Operating Procedures. Key Accountabilities: - Coordinate the identification, feasibility...

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Clinical Trial Assistant - Apply

Lifelancer Pune

About the job Job Overview: Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. Essential Functions: - Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and...

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Clinical VBA Developer - REMOTE - Apply

Lifelancer Pune

About the job Primary Skill: Clinical VBA Developer Years of Experience: 5+ years Job Location: Remote Must Have Skills: VBA, SQL, Clinical Research Process Job description : Design systems, including development and maintenance to support deliverables. Design, development, documentation, and quality assurance of new systems. Defining technical requirements, database structure and...

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Clinical Data Associate II REMOTE - Apply

Lifelancer Pune

About the job Description Clinical Data Associate II Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that...

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Are you looking for a Clinical Research job in the Pune? Whether you’re an experienced job-seeker or have never looked before, you may be asking yourself where to start.

This area has been home to many long-standing businesses as well as several modern companies such as digital media, engineering and industrial services.

If living and working in Pune is something that excites you, then the following article will provide some tips on how to locate available job opportunities in this vibrant metropolitan conurbation. We'll discuss the various sectors that exist, local employers who are recruiting now and different means of searching for roles online.

What do Clinical Research do?

Clinical Research is responsible for providing a range of services to the people of Pune, including education, social care, housing, planning and economic development. It works closely with local businesses and other organisations to ensure that the area remains prosperous and attractive to visitors.

Clinical Research provides a wide range of services to its residents, including job search advice, training and development opportunities, and help with finding suitable accommodation.

Where can I find Clinical Research jobs in Pune?

There are a variety of ways to search for jobs in Pune. The most popular method is to use online job boards such as Jobsora. We allow you to filter your searches by location and sector so that you can easily find roles that match your skills and experience.

You can also search for jobs on the Pune local job websites, which lists all current vacancies in the area. Additionally, you can contact local employers directly to enquire about any available positions.

Finally, there are a number of recruitment agencies based in Pune that specialise in finding people to work in the area. These companies often have access to exclusive job opportunities that are not advertised elsewhere.

In conclusion, there are a variety of ways to find Clinical Research jobs in Pune. Whether you’re looking for a permanent role or something more flexible, the borough has plenty of opportunities available. With the proper research and preparation, you can easily locate the perfect job for you.

How much do Clinical Research in Pune get paid?

Clinical Research in Pune are elected representatives of the local community, and they are paid an annual allowance for their work. The amount of this allowance is determined by the Independent Remuneration Panel for Pune, which reviews the allowances every four years.

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Clinical Research Associate

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Job Details

Clinical Research Associate Job Description

Responsibilities:

  • Identify and qualify potential clinical trial sites and investigators.
  • Set up and equip trial sites with necessary materials and equipment.
  • Train site staff on study procedures and data collection methods.
  • Develop and maintain study manuals and documentation.
  • Conduct regular visits to trial sites to monitor progress and adherence to protocols.
  • Review case report forms and other data for accuracy and completeness.
  • Identify and address any safety concerns or protocol deviations.
  • Report significant findings and updates to sponsors and regulatory authorities.
  • Assist with data analysis and study close-out activities.
  • Prepare final study reports and presentations.
  • Contribute to the regulatory submission process.

Additional responsibilities may include:

  • Managing study budgets and timelines.
  • Liaising with ethics committees and regulatory agencies.
  • Providing scientific and technical support to study teams.
  • Participating in training and development programs.

Qualifications:

  • 0- 2 years' experience 
  • Bachelor's degree in life sciences, nursing, or a related field.
  • Master's degree preferred, especially for senior positions.
  • Good understanding of Good Clinical Practice guidelines and regulations.
  • Excellent communication, interpersonal, and organizational skills.
  • Strong attention to detail and ability to multitask.
  • Ability to travel frequently and independently.

Other Details

  • Department Pharmacist / Medical Representative
  • Industry IT Medical / Healthcare
  • Recruiter Details TECHNO ENDURA
  • Job Tags clinical research
  • Job Type Full time
  • clinical research
  • clinical monitoring
  • clinical practices
  • clinical trials
  • scientific analysis
  • clinical data management

Recruiter Details

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Clinical Research Jobs in Pune

Clinical research coordinator, clinical research associate, sr. clinical research associate, consultant surgical gastroenterology.

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Clinical Research Project Coordinator - Entry Level

Assistant clinical research, medical writer.

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Director, Statistical Programming & Infrastructure (10+years)

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Clinical Trial Assistant

Senior document management associate.

17 days ago

Software Test Specialist

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Global Partnering Associate

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Senior business analyst (clinical trials), precision medicine genetic counselor.

2 months ago

Inside Sales

Trainee - junior data analyst-pharmacovigilance, benefit/risk officer (pharmacovigilance).

19 days ago

Sr. Validation Services Analyst

Clinical pharmacist, apply to 81 clinical research job vacancies in pune, bengaluru / bangalore, hyderabad / secunderabad telangana.

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Average Clinical Research Coordinator Salary in Pune, Maharashtra

The average salary for a Clinical Research Coordinator is ₹180,000 in 2024

Featured Content

What is the pay by experience level for clinical research coordinators .

An entry-level Clinical Research Coordinator with less than 1 year experience can expect to earn an average total compensation (includes tips, bonus, and overtime pay) of ₹237,000 based on 2 salaries. An early career Clinical Research Coordinator with 1-4 years of experience earns an average total compensation of ₹265,000 based …Read more

What Do Clinical Research Coordinators Do?

Clinical research coordinators are responsible for overseeing the daily activities of the staff conducting the research. They work with principal investigators to determine if study is viable and figure out a budget. They also review the protocol of the research, ensure test subjects are familiar with that protocol, and help conduct research.

Generally, clinical research coordinators work in a lab setting with the principal investigator and the lab staff. They also interact with research …Read more

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FAQs About Clinical Research Coordinators

What is the highest pay for clinical research coordinators in pune.

Our data indicates that the highest pay for a Clinical Research Coordinator in Pune is ₹NaN / year

What is the lowest pay for Clinical Research Coordinators in Pune?

Our data indicates that the lowest pay for a Clinical Research Coordinator in Pune is ₹NaN / year

How can Clinical Research Coordinators increase their salary?

Increasing your pay as a Clinical Research Coordinator is possible in different ways. Change of employer: Consider a career move to a new employer that is willing to pay higher for your skills. Level of Education: Gaining advanced degrees may allow this role to increase their income potential and qualify for promotions. Managing Experience: If you are a Clinical Research Coordinator that oversees more junior Clinical Research Coordinators, this experience can increase the likelihood to earn more.

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 UTMB Health Careers

Clinical Research Coordinator, Sealy Center on Aging (Partial Remote, Onsite As Needed)

🔍 galveston, texas, united states.

Minimum Qualifications:

Bachelor's degree or equivalent, and two years of directly related experience.

Job Description:   

The Clinical Research Coordinator obtains human subject data for clinical research activities via methods specified in the study protocol and performs general administrative duties supporting the study.

Job Duties:

  • Applies knowledge in contributing to Good Clinical Practice (GCP) activities and/or other regulatory activities.
  • Schedules, coordinates, and participates in the pre-site visit and site initiation visits; coordinates study initiation.
  • Maintains and monitors source documentation and appropriate forms as per protocol for quality and accuracy, including participant records; assists with the quality assurance process.
  • Incorporates directions from other health care disciplines into clinical research protocols when reviewing patient eligibility; assists in eliciting relevant data from sources outside of the hospital.
  • Conducts behavioral intervention visits in the clinic setting.
  • Develops and maintains productive working relationship with the study monitor; attends and participates in campus coordinator workshops.
  • Identifies and recruits clinical research subjects for participation of studies, collects data, and monitors enrollment goals.
  • Work with research databases to collect milestone research visits and develop reports. RED Cap database knowledge a plus.
  • Mentors new clinical research coordinators and assistant clinical research coordinators.
  • Assists with grant/protocol preparation and submission to IRB, OCR or OSP under direction of research coordinator under the direction of the PI and with answering IRB stipulations to obtain final approval; documents IRB approval and contract approval
  • Knowledgeable of IRB practices e.g., submitting a protocol amendment, protocol deviation, and continuing review.
  • Under direction of PI may draft various communications with Sponsor and/or regulatory documents to be sent to the Sponsor.
  • May assist PI and/or research nurse coordinator in the planning and design of source documents for protocol.
  • Assists in developing procedures for data collection and storage.
  • Assists in processing and sharing data per data use agreements or if indicated asper regulations. Experience working with outside reporting agencies such as CROMS orclinicaltrials.gov a plus.
  • Assists in precepting new clinical research staff and educating other research staff regarding scientific aspects of studies.
  • Assists with the budget development; may monitor ledgers.
  • Adheres to internal controls established for department.
  • May assist PI in obtaining Informed Consent from study participant and documents appropriately.
  • Adheres to internal controls and reporting structure. 
  • If appropriately trained and tested for competency, obtains Vital Signs and performs phlebotomy; monitors participants’ labs and notifies the PI of laboratory findings
  • May attend and participate in the Investigator meeting
  • Performs related duties as required.

Salary Range: $44,320 - $55,400. Commensurate with Experience

Equal Employment Opportunity

UTMB Health strives to provide equal opportunity employment without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, genetic information, disability, veteran status, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. As a VEVRAA Federal Contractor, UTMB Health takes affirmative action to hire and advance women, minorities, protected veterans and individuals with disabilities.

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Requisition #: 2400451

Stanford University

Clinical Research Coordinator Associate

🔍 school of medicine, stanford, california, united states.

Clinical Research Coordinator with project management skills for research on healthy aging, Parkinson’s disease, and aging with HIV infection.

Do you want to help develop world-leading research to better diagnose and treat older adults with HIV infection, older adults with cognitive impairment, or adults with neurological impairment (e.g., Parkinson’s disease)?

If you…

  • Enjoy working directly with patients and their families.
  • Are exceptionally organized and can balance multiple projects at one time.
  • Love learning new skills, such as how to administer neuropsychological tests and motor exams, and how to assess sleep, as well as learning Magnetic Resonance Imaging (MRI) data acquisition skills.
  • Are a proven quick learner who doesn’t need handholding to get started.

Then we offer…

  • The opportunity to contribute to understanding aging and decline in HIV infection, Parkinson’s disease, and related disorders.
  • Challenging but positive environment where you will always learn new things.
  • Teamwork and camaraderie.
  • Competitive full-time salary.
  • Excellent Stanford benefits.

The Poston Lab recruits and follows older normal adults; older adults with mild cognitive impairment; and patients with Parkinson’s disease, Dementia with Lewy Bodies, and related disorders. We are looking for a Clinical Research Coordinator on a project that focusses on healthy aging, Parkinson’s disease, and aging with HIV infection. All these studies collect information on cognition, memory, and other mental abilities, which we link with brain imaging, sleep, brain imaging, and biochemical results.  Research participants will have Parkinson’s disease, treated HIV infection, or another age-related neurodegenerative disorder; some participants will not have any impairment.    

The Poston Lab seeks a full-time Clinical Research Coordinator Associate.  The desired candidate has excellent project management skills and ability to coordinate between multiple teams, is self-motivated, detail-oriented, relatively independent, patient, punctual, and conscientious, with excellent interpersonal skills and excellent communication skills in English. Preference will be given to qualified candidates, who are also native/fluent in Spanish (written and verbal). Under the supervision of Dr. Poston and other study investigators, main duties include project management and coordination between interdisciplinary teams, in-person and telephone recruitment of research participants; obtaining informed consent; scheduling and coordination of research participant visits; maintaining longitudinal contact with participants by phone, email and other means; data collection (including psychometric data), scoring, and data entry. Training will be provided, for example, to administer research questionnaires, psychometric tests, and motor exams, and to acquire sleep assessments and MRI scans.

We like working with other smart, motivated, fun people looking to better the lives of our patients through scientific discovery.  In addition to submitting your on-line resume, please include a cover letter describing your project management and/or clinical research experience and the top five attributes or experiences that make this the right job for you. For more information about our lab and research, please see http://neurology.stanford.edu/labs/postonlab/

Duties include*:

  • Serve as primary contact with research participants, sponsors, and regulatory agencies.  Coordinate studies from startup through close-out.
  • Determine eligibility of and gather consent from study participants according to protocol. Assist with recruitment strategies.
  • Coordinate collection of study specimens and processing.
  • Collect and manage study participant, MRI, sleep, and laboratory data for research projects.  Manage research project databases, develop flow sheets and other study related documents, and complete study documents/case report forms. 
  • Ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents.  Prepare regulatory submissions and ensure institutional Review Board renewals are completed.
  • Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend regular meetings with senior staff/principal investigator, acting as primary contact.
  • Monitor expenditures and adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff.
  • Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct. 
  • Ensure essential documentation and recording of participant and research data in appropriate files per institutional and regulatory requirements.
  • Participate in monitor visits and regulatory audits. 

* - Other duties may also be assigned

This position is fully-onsite.

DESIRED QUALIFICATIONS:

  • Excellent verbal and written communication skills in English required.
  • Excellent verbal and written communication skills in Spanish desired. 
  • Prior experience with patients or research subjects is desired. Preference given to applicants with previous experience, particularly clinical research experience with older adults who may be living with HIV infection, may have neurological impairment (e.g., Parkinson’s disease) or cognitive impairment (e.g., mild cognitive impairment, Alzheimer’s disease). 
  • Ability to communicate clearly and empathetically with research participants and their families.
  • Strong interpersonal skills, including the ability to work easily with research participants and research team members.
  • Strong general computer skills and ability to quickly learn and master computer programs.
  • Strong analytical skills and experience with computer spreadsheets and database software, e.g., RedCap.
  • Proficiency with Microsoft Office and Excel.
  • Ability to work under deadlines with general guidance.

EDUCATION & EXPERIENCE (REQUIRED):

  • BA/BS required; major in neuroscience, psychology, or the biological sciences preferred (equivalent combination of skills, education, and experience will be considered.)  
  • New graduates are encouraged to apply.

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

  • Strong interpersonal skills within a team environment and with study participants.
  • Experience in organizing and implementing multiple complex tasks.
  • Comfort with data collection using a variety of computer interfaces.
  • Attention to detail.
  • Experience with computer programs, such as Microsoft Office Word, Excel, REDCap, and/or other computer interfaces preferred.
  • An understanding of the principles of sound research design and data collection is an advantage.
  • Knowledge of medical terminology.

CERTIFICATIONS & LICENSES:

None required. Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred. 

PHYSICAL REQUIREMENTS*:

  • Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping. 
  • Occasionally sit, reach above shoulders, perform desk-based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds.
  • Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more.

* - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job. WORKING CONDITIONS: 

Occasional evening and weekend hours.

WORK STANDARDS:

  • Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
  • Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.
  • Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, http://adminguide.stanford.edu .

The expected pay range for this position is $31.73 to $36.54 per hour.

Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs.

At Stanford University, base pay represents only one aspect of the comprehensive rewards package. The Cardinal at Work website ( https:/lcardinalatwork.stanford.edu/benefits-rewards ) provides detailed information on Stanford's extensive range of benefits and rewards offered to employees. Specifics about the rewards package for this position may be discussed during the hiring process.

Consistent with its obligations under the law, the University will provide reasonable accommodations to applicants and employees with disabilities. Applicants requiring a reasonable accommodation for any part of the application or hiring process should contact Stanford University Human Resources at [email protected]. For all other inquiries, please submit a contact form .

Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.

The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned.

  • Schedule: Full-time
  • Job Code: 1013
  • Employee Status: Regular
  • Requisition ID: 103783
  • Work Arrangement : On Site

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CLINICAL RESEARCH COORDINATOR, Arringdon Orthopaedic Surgery

Durham, NC, US, 27710

School of Medicine

Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

CLINICAL RESEARCH COORDINATOR, Arringdon Orthopaedic Surgery 

Operations: Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties. Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and SOPs. May train others in these policies and processes. Under supervision, assists with managing investigational products including arrival, storage, and handling (requisitions, inventory, and reordering). Prepares for and provides support for study monitoring and audit visits, including support for the reviewer. Addresses and corrects findings. May train others. Maintains participant-level documentation for non-complex (e.g., questionnaire, data registry, scripted) studies outside of the EHR. Employs strategies to maintain retention rates. Evaluates processes to identify problems with retention. May train or oversee others. Employs and may develop strategies to maintain recruitment rates and evaluate processes to identify problems. Escalates issues. May train or oversee others. Screens participants in person or over the phone for non-complex studies (e.g., questionnaire, data registry, scripted) or may collect information from the EHR to assist study team in determining eligibility. Follows SOPs. Independently employs simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens. Assists with establishing and maintaining study level documentation. Schedules participants for research visits. Prepares necessary documents, equipment, supplies, etc. Conducts and documents non-complex visits and scripted testing or interviews. May manage participant payment. Participates in study team meetings. Ethics: Identifies all AEs, and determines whether or not they are reportable. Collaborates with the PI to determine AE attributes, including relatedness to study. May train or oversee others. Conducts an d documents consent for participants in non-complex studies. These are typically repositories, survey studies, simple observational studies and no n-patient studies that do not involve investigational products or devices. Cannot consent for any studies that involve investigational products or devices or require clinical research orders in Maestro Care (i.e., electronic health record). Assists with the development of consent plans and documents for participants. Develops and submits documentation and information for IRB review. Communicates with the IRB staff and reviewers and handles issues appropriately. May train or oversee others. Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies. May train or oversee others. Data: Enters and collects data. Develops data entry or collection SOPs or tools. May provide oversight or training to study team members collecting or entering data. Ensures accuracy and completeness of data for all studies, including those that are complex in nature. Recognizes data quality trends and escalates as appropriate. May develop tools for, and train others in, data quality assurance procedures. Recognizes and reports security of physical and electronic data vulnerabilities. May develop or review RDSPs for multiple study protocols. Maps a protocol's data flow plan including data capture, storage, transfer, management, quality, an d preparation for analysis (may include data from EDCs, EHR, mobile apps, etc.). May train or oversee others. Learns and uses new technology when required. Science: Under guidance, develops section s of protocols for simple studies (e.g., registries, survey studies). Demonstrates a basic understanding of the elements of research study designs . Study and Site Management: 

Prepares for, coordinates, and actively participates in site visits. Communicates effectively with sponsors and/or CROs. Records participant accrual information and con sent documentation for non-complex studies in clinical research management system. Records basic protocol information in clinical research management system. Collects appropriate information to determine whether the study team's participation in a specific trial is feasible. May make recommendations. For studies with simple supplies or equipment, ensures that there are ample supplies and that equipment is in good working order. Ensure s that studies are conducted in compliance with institutional requirement and other policies. Follows, and may develop or implement, protocol-specific systems and documents including process flows. May train or oversee others. Prepares studies for closeout and document storage. May train or oversee others. Leadership: Maintains Duke and project specific training requirements. Keeps current with research updates by attending key external offerings (i.e. Research Wednesday, RPN, events outside of Duke, etc.) and applies the learned material to the job. May disseminate information to others. Serves on committees and workgroups internal to Duke or externally in therapeutic area of research. Navigates processes and people involved in Duke clinical research, demonstrates the organizational awareness, and has the interpersonal skills necessary to get work done efficiently. Develops and implements solutions that work within the existing leadership or organizational structure. Demonstrates resilience and is adaptive to change. Uses advanced subject matter expertise in the therapeutic area or clinical research to solve problems. Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives. Type of Research: This project is examining Biopsychosocial Influence on Shoulder Pain: Total Shoulder Arthroplasty. The coordinators role will require collection of patient medical data, phlebotomy training for blood collection prior and after surgery as needed, potential delivery of samples to the lab for analysis. This is a high enrolling study that will require travel to other clinics and locations outside of Duke Main Hospital Special skills: Willingness to draw blood and independently travel to a variety of locations.

Minimum Qualifications

Completion of an Associate's degree

Work requires a minimum of two years of relevant research experience. A Bachelor's degree may substitute for 2 years required experience.

Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.

Nearest Major Market: Durham Nearest Secondary Market: Raleigh

Duke is an Affirmative Action / Equal Opportunity Employer committed to providing employment opportunity without regard to an individual’s age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status. Read more about Duke’s commitment to affirmative action and nondiscrimination at hr.duke.edu/eeo.

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  30. CLINICAL RESEARCH COORDINATOR, Arringdon Orthopaedic Surgery Job

    CLINICAL RESEARCH COORDINATOR, Arringdon Orthopaedic Surgery Operations: Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties. Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and SOPs.