Clinical Research Coordinator
Mass General Brigham
- Boston, MA
- Contract
- Full-time
- Prepare protocol applications, staff and protocol amendments, safety reports, adverse event reports, and other regulatory submissions to local IRB and central IRBs.
- Report to Project Manager and lab PI and communicate trial status, including IRB approval, continuing reviews, recruitment and enrollment reports, and subjects’ appointments and surgeries.
- Manage and maintain regulatory documents for audit and routine Sponsor monitoring visits.
- Work with physicians and sub-investigators and use in-house API tools to identify potential clinical trial candidates. Screen eligible clinical trial subjects, and lead recruitment and retention efforts.
- Review medical records and laboratory results for study relevant clinical data.
- Coordinate with clinical care team to schedule study visits. Attend study visits and subsequent assessments as outlined in Study Protocols. Complete monthly recruitment and enrollment reports for Study PI and Sponsors.
- Conduct ongoing review of study progress and communicate concerns with the study investigator and the subject’s primary care provider.
- Enter collected data into electronic data capture systems, e.g., Medidata, Veeva per EDC completion guidelines.
- Maintain confidential patient files including all correspondence, information, raw data, and followup status of study subjects.
- Assist project manager in organization of site qualification/feasibility visits, site initiation visits, and closeout visits with Sponsors.
- Desired: Experience in processing, storing, and shipping biospecimens
- Desired: Oversee clinical trial budgets, electronic billing, Sponsor invoicing, and reconciliation of financial statements. Maintain communication channels with hospital grant department, financial analysts, and Clinical Trials Office, to address any administrative issue in a timely manner.
- Knowledge of data management concepts, HIPAA/patient data privacy regulations, ICH Good Clinical Practice, and federal Human Subjects Protections requirements. Quick to learn institutional guidelines and policies
- Excellent interpersonal and communication skills. Ability to interact effectively with many different people including patients, doctors, nurses, grant administrators, project and program managers, and researchers
- Exceptional organizational skills and the flexibility to handle multiple tasks and deadlines
- Computer skills including configuration of operating systems, word processing, email, and spreadsheets
- Good command of English language, including basic medical and scientific terminology
- Desired: familiarity with research contract negotiation process
- Desired: familiarity with OnCore CTMS and EPIC EMR
- Submit and track sponsor invoices for milestone payments, patient care corrections, and reimbursements and research stipends as needed.
- Submit staff expense reports for reimbursement and per-contract work.
- In coordination with departmental grant manager, reconcile study funds against invoices and follow up on outstanding payments.
- Purchase clinical trial equipment and supplies, as necessary, as allowed by clinical trial agreements.
- Purchase other general lab supplies, as necessary.