Clinical Research Coordinator I

About the Role

Massachusetts General Hospital is seeking a Clinical Research Coordinator I to join the Neurological Clinical Research Institute (NCRI). This role supports the advancement of medical discoveries through patient care, research, teaching, and community service.

Key Responsibilities

• Coordinate all activities of subjects participating in individual research studies.
• Schedule patients for research studies.
• Collect, organize, and document patient data from each visit.
• Maintain records and databases.
• Assist with recruiting patients for clinical trials.
• Obtain patient study data from medical records and physicians.
• Verify the accuracy of study forms and update them per protocol.
• Prepare data for analysis and data entry.
• Assist with regulatory binders and QA/QC procedures.
• Administer and score questionnaires.
• Provide a basic explanation of the study and obtain informed consent from subjects.
• Perform study procedures such as phlebotomy, vital signs, and electrocardiogram.
• Draft consent forms.
• Correspond with the Institutional Review Board (IRB) for protocol approval, adverse event notification, study continuation, annual reporting, and amendment submission.
• Assist professional staff with patient treatment according to study guidelines (e.g., arrange blood draws, perform phlebotomy, process fluids, record medical histories, set up rooms for procedures).
• Understand primary study details to answer questions from staff and patients regarding test timing or required lab orders.
• Ensure investigators receive test results as appropriate.
• Provide, create, and maintain record-keeping systems: data collection forms, consent forms, side effect sheets, drug accountability and medication logs, initialization forms, and case report forms (CRFs).
• Perform data entry into study databases.
• Communicate with the study sponsor, including scheduling and conducting monitoring visits.
• Work cooperatively with the study sponsor to ensure good clinical practices are followed.
• Interact internally with other hospital departments (e.g., Dieticians, Harvard Catalyst CRC, Pharmacy, Environmental Services) and externally with regulatory agency personnel.
• Perform other administrative support duties as assigned.
• Accept responsibilities for special projects as requested.
• Perform other job-related duties as required.

Requirements & Tech Stack

• Computer literacy
• Working knowledge of clinical research protocols.
• Experience with federal regulations (i.e., FDA, CFR, etc.), IRB review process, informed consent, trial design, data monitoring.
• Good writing and editing skills.
• Prior experience working in clinical research is a plus.

Qualifications

Education

• Bachelor's Degree in a related field of study required.
• Candidates completing their bachelor's degree have a six-month grace period from their hire date (up to one year if starting on a per diem basis) to provide degree equivalency verification.
• Experience can be accepted in lieu of a degree.

Experience

• Some relevant research project work.
• 0-1 year of experience preferred.
• Relevant coursework or project work.

Skills/Abilities/Competencies

• Careful attention to detail.
• Good organizational skills.
• Ability to follow directions.
• Good interpersonal and communication skills.
• Ability to demonstrate respect and professionalism for subjects' rights and individual needs.
• Ability to multitask.
• Excellent verbal and written communication skills.
• Able to work with deadlines and in stressful environments.
• Ability to interact well with others and work as part of a team with minimal supervision.
• Appropriate decorum with direct contact with a terminal patient population.

Working Conditions

• Office work.
• May have a rotating 8-hour shift on Tuesdays between 7:30 am and 6:30 pm.
• May travel.
• Exposure to dry ice and -80-degree freezers.
• May have to lift up to 20 lbs and apply force to resist patients/subjects in hand-held dynamometry.
• May be exposed to bodily fluids, including blood, urine, and cerebral spinal fluid.
• May work at different MGH or Partners sites, including Main Campus, Charles River Plaza, and Charlestown Navy Yard.