Located in Boston, 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.
This position will work within the clinical 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. 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).
PRIMARY DUTIES AND RESPONSIBILITIES:
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.
Performs duties as above with greater independence and has progressed to performing more advanced skills. Will conduct basic analysis of data and provide increasingly more sophisticated reporting or analysis of results as directed by the Principal Investigator. May confirm eligibility and registers patients onto protocols as needed. Comprehension of state and federal guidelines for clinical trials. Understands research and protocol design. Ability to execute complex regulatory submissions. Contributes to protocol development and design processes. Understands advanced principles of human research subject protection. Ability to manage complex trials including multi-center. Works very independently and will mentor entry-level CRC’s.
Bachelor’s Degree preferred. 3-5 years of experience preferred. Performs primary duties above independently 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.
May have contact with patients of all ages and populations. May distribute protocol schedules, quality of life surveys or other study-related questionnaires, and/or conduct follow-up communications with patients.
40 hours per week
Dana-Farber Cancer Institute is an Affirmation Action/Equal Opportunity Employer - committed to diversity and inclusion in our workforce.
Dana-Farber Cancer Institute - 22 months ago