Clinical Research Coordinator I

Massachusetts General Hospital
United States, Massachusetts, Boston
15 Parkman Street (Show on map)
Mar 26, 2025
Responsible for oversight of defined clinical protocols including advertising for the recruitment of study patients, scheduling clinical research study patients for testing with various hospital departments, screening normal volunteers and patients for study participation; arranging management of patients with general clinician supervision. Responsible for reviewing lab results with study clinicians to ensure that protocol requirements are met and that abnormalities are addressed; collecting and collating data from numerous sources including various laboratories, Clinical Research Unit, and MGH imaging centers; maintenance of primary data in research databases and patient charts (lab results, radiology reports); management of data generated by research protocols; and coordination of feedback to P.I.s. Collaborates with supervisor to create and maintain a database of the information from the clinical protocols, including data entry and accuracy. Synthesizes and interprets information obtained from the sources mentioned above to prepare statistical and graphic summaries of findings and conclusions; collaborates with supervisor in writing and editing material for publication. The Coordinator will complete applications/forms/reports and submit them in a timely manner to various research bodies like the Institutional Review Board (IRB), the Research Pharmacy, the NIH and the FDA. Specific Duties: STUDY VISIT RELATED Work closely with the study nurse practitioner and PIs to conduct the study with subject safety and data integrity as the priorities Acts as study resource for subject and family Assists with recruiting subjects for clinical trials Develops and implements recruitment strategies Schedule and conduct study visits with volunteers, including assessments such as administering computerized questionnaires, and collecting biological samples (e.g., pregnancy tests, blood draws). Training provided. Conduct structured clinical interviews for psychiatric disorders, including eating disorders and suicidal ideation. Training and supervision with clinical psychologist provided. Perform study procedures such as vital signs.(Training provided) Provides basic explanation of study Works with clinicians to screen subjects for suitability of research study participation and verifies subject inclusion/exclusion criteria Orders supplies, schedules study appointments, processes volunteer stipends, and schedules meetings Escorts study volunteers to appointments Administers/scores/evaluates study questionnaires Assists with interviewing study subjects Collects, organizes and interprets patient data Monitors and evaluates lab and procedure data Create and maintain a variety of study logs, including billing logs Maintain subject charts, regulatory binders and study databases Communicate with clinicians, study volunteers, etc., using HIPAA guidelines Performs study procedures such as phlebotomy (Training provided) Work with human tissue (i.e. blood, etc.) using Standard Precautions Collects, processes, and stores study samples (-80C freezers) Orients and trains junior team members on the study protocols as appropriate Visits take place at Massachusetts General Hospital and McLean Hospital Skills/Abilities/Competencies Required: 1.The Clinical Research Coordinator I should have the following skills and competencies: 2. Good organizational skills 3. Careful attention to details and ability to follow directions 4. Proficiency with MS Office including Microsoft Excel, Word and Powerpoint. 5. Additional experience working with databases such as JMP and REDCap preferred. 6. Ability to work independently and as a team member Analytical skills and ability to resolve technical problems 7. Ability to multi-task and prioritize responsibilities and handle fluctuating deadlines 8. Good interpersonal skills and an interest in working with human research participants 9. Excellent written and verbal communication skills, as well as strong organizational skills to handle multiple tasks in a busy environment Excellent organization skills and attention to detail 10. A willingness and ability to learn Qualifications: Education: Bachelor's Degree required (BS preferred though not required) Experience: New graduates with some relevant course/project work or those without any prior research experience will be considered for the Clinical Research Coordinator I position outlined above. Those with a minimum of 1-2 years of directly related work experience will be considered for a Clinical Research Coordinator II position. 1-2 years of clinical research experienceis strongly preferred SUPERVISORY RESPONSIBILITY(if applicable): A Clinical Research Coordinator I does not have any supervisory responsibility. A Clinical Research Coordinator II may assist with the training and orientation of new staff members. OFFICE RELATED Maintains all hard and digital copies of study files General clerical tasks (file, photocopy etc.) Uses software programs to generate graphs and reports Conducts library searches Verifies accuracy of study forms Updates study forms per protocol Obtains patient study data from medical records, physicians, etc., using HIPAA guidelines Recommends protocol changes and may assist with writing protocols and manuscripts Works with PI to prepare complete study reports Create agenda for and attend weekly clinical research meetings with staff and PI, be prepared to report on study progress Assists with transfer, accountability, and destruction of investigational product, including controlled substances, in clinical trials under proper supervision of registered physician investigator. Maintains study codes Assist in the coverage of other research studies when necessary Oversees funds and invoices The General Hospital Corporation is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.