"Clinical Research Coordinator II"

This position works within the Bona Lab in the Pediatric Outcomes research program and supports the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator(s) and the DFCI Clinical Trials Office. The CRC II 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 state, federal, and IRB requirements. Responsible for IRB protocol submissions (amendments, continuing reviews, and minimal risk protocols). This individual may also screen patients for protocol eligibility, obtain informed consent, and register study participants to clinical trials. Some travel may be required.

Please include a cover letter why you are interested in working in this role.

Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS, and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.

• Oversight of the clinical trials start-up process from receipt of protocols through the Scientific Review Committee and IRB submissions, and site activation activities
• 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
• May prepare and or complete regulatory related reports and IRB submissions. Maintain and organize study participant/subject trial binder and regulatory binders, enter all required study data on an ongoing basis and as applicable
• Ensure all study related samples are collected, properly prepared, and shipped according to the protocol requirements and IATA/DOT regulations
• Collaborate with other departments such as Protocol Scheduling, Materials Management, the Clinical Research Laboratory, Pharmacy, Research Nursing, and other departments, as needed per the requirements of the clinical trial
• Responsible for organizing and preparing for both internal and external auditing and study monitoring visits
• Coordination and management of clinical trials throughout the trial life cycle, including communication with sponsors and regulatory authorities
• Close-out of clinical trials, including contributing to research articles, audit preparation, and communication with regulatory agencies and other disciplines involved
• Interact with study participants as directed/required by the protocol and/or study team
• May be responsible for tissue sample collection per trial requirements

KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:

• Excellent organization and communications skills required
• Strong interpersonal skills - ability to effectively interact with all levels of staff and externals contacts
• Must be detail oriented
• Ability to effectively manage time and prioritize workload
• Must practice discretion and always adhere to hospital confidentiality guidelines
• Must have computer skills including the use of Microsoft Office

MINIMUM JOB QUALIFICATIONS:

The position requires a bachelor's degree or 2 years of experience as a Dana-Farber Clinical Research Coordinator. Candidates should have 1-3 years of relevant experience, with a preference for those with a background in public health, public policy, health equity, or similar fields.

SUPERVISORY RESPONSIBILITIES:

Orients and assists in training new staff.

PATIENT CONTACT:

May have contact with Adult and Pediatric patients of all ages and populations. May distribute protocol schedules, quality of life surveys or other study-related questionnaires, subject diaries, and/or conduct follow-up communication with patients.