Clinical Research Coordinator - Brighton

The Clinical Research Coordinator will work within the Brighton Dana‑Farber Satellite clinical research program and support 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 disease programs. The Satellite CRC will be responsible for the primary data collection, management of patient clinical information, and regulatory documents as it pertains to participation in clinical trials across all studies open at the Satellite site(s). Ensures timely collection of protocol related samples including shipment to outside entities as required. Maintains site regulatory binders and ensures study compliance with all state, federal, and IRB requirements. May be responsible for site IRB submissions (violations, deviations, severe adverse event reports). This individual may also screen patients for protocol eligibility, obtain informed consent (minimal risk studies), and register study participants to clinical trials. Travel to the Longwood campus and other DFCI Satellite sites may be required. This position is based at the Brighton campus. 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. Responsibilities Oversight of the clinical trials regulatory process at the DFCI Satellite(s) and site activation activities Communication and coordination with the lead study team at the Longwood campus for study start‑up, ongoing study team meetings, and project management of all site study activities Responsible for data reporting and management, collection of source documents, use of case report forms, adverse events reporting, filing and archiving of study records, and resolution of data queries for all studies at the Satellite site(s) Prepare and/or complete regulatory related reports and IRB submissions as it pertains to the satellite’s studies. Maintain and organize study regulatory binders, enter all required study data on an ongoing basis Maintains various regulatory tracking databases with information related to study recruitment, subject enrollment, and study progress and completion 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 all clinical trials at the Satellite site(s), 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 Travel between DFCI satellite locations to support all above research activities when cross coverage is needed Maintain working knowledge of current regulations, regulatory guidance and or local policies May be responsible for preparing and presenting study status regulatory status for satellite site clinical team members at monthly research meetings Knowledge, Skills, And Abilities Required Excellent organization and communications skills Strong interpersonal skills with the 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 Minimum Job Qualifications The position requires a bachelor’s degree, with 0 to 1 year of related experience preferred. Experience in a medical, scientific research, or technology‑oriented business environment is also preferred. The role requires close to moderate supervision. SUPERVISORY RESPONSIBILITIES: None PATIENT CONTACT: Minimal patient contact. 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. Pay Range: $48,100.00 - $54,400.00 #J-18808-Ljbffr Dana-Farber Cancer Institute