Located in Boston and the surrounding communities, Dana-Farber Cancer Institute brings together world renowned clinicians, innovative researchers and dedicated professionals, allies in the common mission of conquering cancer, HIV/AIDS and related diseases. Combining extremely talented people with the best technologies in a genuinely positive environment, we provide compassionate and comprehensive care to patients of all ages; we conduct research that advances treatment; we educate tomorrow's physician/researchers; we reach out to underserved members of our community; and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.
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 state, federal, and IRB requirements. May be 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 with the Quality Assurance Office for Clinical Trials (QACT).
- 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.
- 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.
- Ensure all study related samples are collected, properly prepared and shipped according to the protocol requirements and IATA/DOT regulations.
- Responsible for organizing and preparing for both internal and external auditing and study monitoring visits.
- Coordination and management of clinical trials, 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 work.
- Orients and assists in training new staff.
- Bachelor's Degree required or 1-3 years of equivalent experience required. Experience working in a medical or scientific research setting or comparable technology orientated business environment preferred. Performs primary duties with greater independence and has progressed to performing more advanced skill sets as directed.
- 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 and have the ability to follow-through. Ability to effectively manage time and prioritize workload. Must practice discretion and adhere to hospital confidentiality guidelines at all times. Must have computer skills including the use of Microsoft Office.
- Proficient in understanding of phases of clinical trials.
- Ability to coordinate PI initiated studies.
Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other groups as protected by law.