Job Type: Per Diem

Time Type: Part time

Work Shift: Day (United States of America)

FLSA Status: Non-Exempt

When you join the growing BILH team, you're not just taking a job, you’re making a difference in people’s lives.

Position Summary: Under the general supervision and direction of the Clinical Research Associate, the Data Coordinator will be responsible assisting the CRA in implementation of clinical trials. The Data Coordinator provides administrative support to the CRA in all aspects of clinical trial coordination (regulatory, clinical and admin). He or she will also provide a variety of support to the professional and support staff of the Lahey Clinic in the conduct of clinical trial.

Job Description:

Essential Duties & Responsibilities including but not limited to:

1. Prepares internal checklists/tracking systems to monitor the conduct of the study. 2. Utilization of established departmental systems for trial coordination. May assist in development of study specific computer/administrative organizational systems for trial coordination (ie: study specific) 3. Assists CRA in study submission to Research Administration for Institutional Review Board (IRB) review. 4. Completes Research Office forms for the review of the study by the IRB.

5. Prepares and provides appropriate forms advising of required tests, timing of tests etc.

6. Assures at the direction of the CRA, that all appropriate treating physicians receive the results of study tests, as appropriate.

7. Utilizes Lahey Clinic's mainframe computer to schedule tests and appointments, and to access patient data and test results.

8. Assists in establishing monitoring tools to ensure the adherence to study protocol.

9. Prepare / submits adverse event (AE) reports to IRB, FDA, and study sponsor

10. Assists the CRA in enrolling eligible study patients by assessing potential patients eligibility

11. Check all eligibility criteria with patient’s medical record. Verify this information with the CRA or PI

12. Assists in preparation of yearly progress reports for submission to the IRB for review.

13. Assists under the supervision of the CRA, completes case reports forms utilizing source documents

14. Creates shadow binders for each study subject

15. Assists CRA to prepare records for audit/monitor visits

16. Answer queries from sponsors

17. Attend departmental and group meetings as they occur as well as any necessary meeting with study sponsor

Minimum Qualifications:

Education: Associate Degree in Science or equivalent work experience.

Licensure, Certification, Registration: N/A

Skills, Knowledge & Abilities: Knowledge of medical terminology, word-processing, data entry knowledge of Access and Excel. Strong orginizational and communication skills. Ability to interact with professional personnel at all levels. Ability to prepare reports; able to locate, organize and prepare medically related information for study purposes. In the absence of any of these skills, demonstrates the ability to be thoroughly trained to meet organizational standards.

As a health care organization, we have a responsibility to do everything in our power to care for and protect our patients, our colleagues and our communities. Beth Israel Lahey Health requires that all staff be vaccinated against influenza (flu) and COVID-19 as a condition of employment. Learn more about this requirement.

More than 35,000 people working together. Nurses, doctors, technicians, therapists, researchers, teachers and more, making a difference in patients' lives. Your skill and compassion can make us even stronger.

Equal Opportunity Employer/Veterans/Disabled