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Clinical Research Coordinator
1 month ago
Description
GENERAL SUMMARY/ OVERVIEW STATEMENT:
The Brain Modulation Lab in the Department of Neurosurgery at Massachusetts General Hospital seeks a highly motivated, detail-oriented, self-directed Clinical Research Coordinator II for the management of clinical trials and research. This individual will be responsible for all tasks related to data and sample collection for ongoing clinical trials including subject recruitment and enrollment, follow-up visits and phone calls, capturing clinical data, conducting study visits, and maintaining relationships with Sponsors and collaborators. There will be a strong focus on patient recruitment and retention, completing clinical trial related tasks, and other regulatory responsibilities. This individual will work in close collaboration with the PI (Mark Richardson, MD PhD) and clinical research project manager and will routinely interact with patients, nurses, and physicians.
A minimum of 1-year experience of clinical trial execution and experience with regulatory documentation is required. Clinical research certification (such as CCRC, CCRP or other certification approved by the PI) is highly preferred. A candidate will be considered if they demonstrate equivalent work experience and commits to obtaining certification within 6 - 12 months of hire date.
A minimum 2 year commitment will be preferred given the complexity of the work.
Clinical Trial Responsibilities:
Manage and oversee day-to-day operations and ensure integrity of clinical trials. 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, ., 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.
Qualifications
Skills and competencies:
Independence, problem-solving capabilities, and willingness and dedication to troubleshoot technical issues 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 EMRLICENSES, CERTIFICATIONS, and/or REGISTRATIONS:
Clinical Research Coordinator Certification (CRCC) – highly preferred. Candidates who are able to demonstrate equivalent work experience and commit to obtaining certification within 6 - 12 months of hire date will be considered.
EDUCATION:
Bachelor’s degree in a science or healthcare related-field is required.
EXPERIENCE:
A minimum of 1-year experience with clinical trial execution and experience with regulatory documentation is required. Experience in investigational drug or device studies and gene therapy strongly preferred.
SUPERVISORY RESPONSIBILITY:
None
FISCAL RESPONSIBILITY:
Perform hospital billing review for patients enrolled in clinical trials. Assist clinical coordinators with insurance inquiries and prior authorization requests. 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.WORKING CONDITIONS:
Hybrid. Duties will be primarily performed in a hospital inpatient, operative, clinic, and office settings. Some responsibilities are able to be performed remotely.
