Job Description

Overview Clinical Research Coordinator - Population Science role at Dana-Farber Cancer Institute. The CRC works within the clinical research program and supports the research team in the conduct of clinical trials using Good Clinical Practice under the Principal Investigator. Primary data collection and management of patient clinical information for 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 state, federal, and IRB requirements. May be responsible for IRB protocol submissions (amendments, continuing reviews, and minimal risk protocols). May screen patients for protocol eligibility, obtain informed consent, and register study participants with the Quality Assurance Office for Clinical Trials (QACT). Some travel may be required. This position’s work location is onsite at our Longwood Medical Facility in Boston, MA with up to one day per week remote. The selected candidate may only work remotely from a New England state (ME, VT, NH, MA, CT, RI). 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. Coordinate internal and external auditing and study monitoring visits. Coordinate and manage 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. Qualifications Bachelor's Degree required, with 0-1 years of related experience preferred. Experience in a medical or scientific research setting or a technology-oriented business environment preferred. Excellent organization and communication skills; strong interpersonal skills; ability to interact with all levels of staff and external contacts. Detail oriented with ability to follow through; ability to manage time and prioritize workload; discretion and adherence to hospital confidentiality guidelines. Proficiency in Microsoft Office. Equal Opportunity 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 characteristics protected by law. Compensation and Location Location: Longwood Medical Facility, Boston, MA. Remote work: up to one day per week from a New England state. #J-18808-Ljbffr Dana-Farber Cancer Institute

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