These positions work within the clinical research program and support the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator(s) and the DF/HCC Clinical Trials Office and/or Partners HealthCare Institutional Review Board (IRB). The CRC will be responsible for the primary data collection and management of patient clinical information as it pertains to participation in clinical trials. Ensures timely collection of protocol related samples including shipment to outside entities as required. Maintains regulatory binders and ensures study compliance with all local, state, federal, and IRB requirements. May be responsible for IRB protocol submissions (amendments, continuing reviews, and protocols). This individual may also screen patients for protocol eligibility, obtain informed consent, and register study participants to clinical trials.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
1. Oversight of the clinical trials start-up process from receipt of protocols through the Scientific Review Committee and IRB submissions, and site activation activities.
2. Responsible for data reporting and management, collection of source documents, use and development of case report forms, adverse events reporting, filing and archiving of study records, and resolution of data queries.
3. Prepare and or complete regulatory related reports and IRB submissions. Maintain and organize study regulatory binders, enter all required study data on an ongoing basis.
4. Ensure all study related samples are collected, properly prepared and shipped according to the protocol requirements and IATA/DOT regulations.
5. Responsible for organizing and preparing for both internal and external auditing and study monitoring visits.
6. Coordination and management of clinical trials, including communication with Sponsors and regulatory authorities.
7. Close-out of clinical trials, including contributing to research articles, audit preparation, and communication with regulatory agencies and other disciplines involved.
8. Interact with study participants as directed/required by the protocol and/or study team.
9. May be responsible for tissue sample work.
The following competencies are necessary to qualify for the CRC II and Lead CRC
Clinical Research Coordinator II
• Demonstrates understanding of CRF completion, including timely and accurate transcription of study data
• Shows an understanding in setting up, coordinating and managing clinical research studies
• Shows an understanding of ICH/GCP and Federal Regulatory requirements
• Shows an understanding of DF/HCC SOPs
• Shows an understanding of the roles and responsibilities of other key departments within clinical research (ex. OHRS, ODQ, DFCI CTO etc.)
• Proficient in understanding of phases of clinical trials
• Is competent and autonomous with minimal assistance and supervision.
Lead Clinical Research Coordinator
• Supports, trains and meets the educational needs of CRCs I and II
• Provides daily oversight of the projects they lead and is accountable for the projects lead
• Articulates understanding of ICH/GCP and Federal Regulatory requirements and provides education of these to CRCs I and II
• Articulates understanding of DF/HCC SOPs and provides education of these to CRCs I and II
• Has a comprehensive understanding of the roles and responsibilities of other departments within clinical research (ex. OHRS, ODQ, DFCI CTO etc.)
• Contributes to the development of research protocols and understands research design
• Recognizes own learning needs as well as their team's needs and takes responsibility for maintaining up to date knowledge
• Tracks team deadlines such as FDA reports, Monitoring visits, etc and prepares team members to meet said deadlines
Required: Bachelor's Degree
Required:0-2 years exposure to scientific methods either in a lab or classroom setting
Preferred: 1-4 years exposure to clinical research in a lab or office setting. Experience working in a medical or scientific research setting or comparable technology orientated business environment preferred.
Brigham and Women's Hospital is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, sexual orientation, protected veteran status, or on basis of disability.