Job Description

Overview The Clinical Research Coordinator works within the clinical research program and supports the research team in the overall conduct of clinical trials under Good Clinical Practice, under the auspices of the Principal Investigator. The CRC is responsible for primary data collection and management of patient clinical information related to participation in clinical trials. Responsibilities include timely collection of protocol-related samples (including shipment to outside entities as required), maintaining regulatory binders, and ensuring study compliance with all state, federal, and IRB requirements. This role may involve IRB protocol submissions (amendments, continuing reviews, and minimal risk protocols). The individual 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). About the Organization 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 partners, including other Harvard Medical School-affiliated hospitals. 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 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. Qualifications Bachelor7s Degree required, with 0-1 years of related experience preferred. Experience working in a medical or scientific research setting or comparable technology-oriented business environment preferred. Knowledge, Skills, and Abilities Excellent organization and communications skills required. Strong interpersonal skills – ability to effectively interact with all levels of staff and external 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. Equity, Diversity, and Equal Opportunity At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As relentless as we are in our mission to reduce the burden of cancer for all, we are equally committed to diversifying our faculty and staff. Cancer knows no boundaries and when it comes to hiring the most dedicated and diverse professionals, neither do we. 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. #J-18808-Ljbffr Dana-Farber Cancer Institute

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