Building upon Dana-Farber’s deep experience in early cancer detection and treatment, we’ve created a robust, integrated clinical/research program -- Centers for Early Detection and Interception. This program brings together Dana-Farber’s expert clinicians and researchers across all cancer types, working together in a unified, multi-disciplinary effort that will accelerate progress in early cancer detection and interception. Through this effort, we will help stop cancer earlier, saving more lives, and improving the quality of life for all of those affected by cancer. The Clinical Research Coordinator II (CRC II) will be an integral part of the clinical research program and lead recruitment as we expand into the Boston-area community. Our goal is to increase access to research for patients who traditionally do not have access to clinical trials. This role will support the research team in the execution of clinical trials in accordance with Good Clinical Practice and will operate under guidance of the Principal Investigator(s), the DFCI Clinical Trials Office, and the Clinical Research Director. The CRC II will be responsible for recruiting, screening for protocol eligibility, and obtaining consent from patients for industry-sponsored and biobanking studies. In this way, the CRC II will be responsible for collecting, compiling, and managing patient clinical information. The CRC II will ensure prompt collection and shipment of protocol-related samples to external entities as necessary. Responsible for maintaining regulatory binders and assuring study compliance with all state, federal, and IRB mandates. This individual will also register study participants to clinical trials. This role will spend a significant portion of their time working autonomously at other research locations up to 90min from DFCI and should have the means to travel locally for their daily work. 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. + 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. + Liaison with community partners in setting up clinical trial and recruitment processes. + Leading recruitment and consenting efforts at community sites. + Timely entry of study data into clinical trials management software. **SUPERVISORY RESPONSIBILITIES:** Orients and assists in training new staff. + Bachelor’s Degree and 1-3 years of equivalent experience required. + Experience working in a medical or scientific research setting or comparable technology orientated business environment preferred. **COMPETENCIES:** + Demonstrates understanding of CRF completion, including timely and accurate transcription of study data + Shows an understanding in setting up, coordinating and managing clinical research studies + Shows an understanding of ICH/GCP and Federal Regulatory requirements + Shows an understanding of DF/HCC SOPs + Shows an understanding of the roles and responsibilities of other key departments within clinical research (ex. OHRS, QACT, CTO etc.) + Proficient in understanding of phases of clinical trials + Ability to coordinate PI initiated studies + Is competent and autonomous with minimal assistance and supervision. **KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:** + 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. + Comfort working autonomously in clinic. + Must have computer skills including the use of Microsoft Office. + Bilingual in Spanish, Portuguese, Chinese, or Hatian Creole strongly preferred. + Experience working in community outreach or engagement strongly preferred. 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. If working in this kind of organization inspires you, we encourage you to apply. 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. **EEOC Poster**