The Senior Director, Dana-Farber Cancer Institute (DFCI?s) Clinical Research Network (CRN) oversees clinical research administration functions occurring outside of Boston?s Longwood Medical Center Area - including clinical trials activities and teams across DFCI?s Collaborative, External, and Regional Sites. The Senior Director monitors and supports teams responsible for study start-up activities, site activation and maintenance, compliance with all regulatory requirements and Federal guidance, subject accrual and management in close coordination with physician investigators, nursing, finance, and regulatory operations. The Director is responsible for supporting and growing DFCI?s Clinical Research Network and partners cross functionally to expedite site activation and study-related activities and reporting.
The selected candidate may only work remotely within the New England states (ME, VT, NH, MA, CT, RI).
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.
Oversees site operations across DFCI?s extensive network of in- and out-patient centers offering all phases of clinical trials, both treatment and non-treatment, to patients across DFCI and DFCI-affiliated sites.
Onboards, trains, educates, and mentors teams supporting DFCI?s Clinical Research Network.
Deploys teams/resources to meet all local, state, and Federal reporting requirements to mitigate significant regulatory risks to the DFCI CRN.
Audits and monitors readiness, corrective action planning, response, and adherence.
Supports DFCI investigators/Disease Centers via shared resources to efficiently initiate and manage clinical research activities and accruals across the DFCI CRN.
Partners with key stakeholders across sites to grow and support site selection and activation, patient recruitment, subject management and regulatory compliance.
Solves for sites? operational issues with a focus on building strong working relationships and network expansion.
Coordinates and manages monthly DFCI CRN meetings with participation from active DFCI CRN sites.
Aggregates and reports associated metrics and budget performance to DFCI Leadership.
SUPERVISORY RESPONSIBILITIES:
Directly oversees 3-4 Director-level employees and project management functions associated with the day-to-day operations of the DFCI CRN.
Bachelor?s Degree in a healthcare-related field required. Advanced degree (MS, MSN, MHA) preferred.
15 years of clinical trials clinical and regulatory operations management experience required.
15 years of progressive management responsibility required.
5 years audit preparation experience required.
5 years clinical trials site activation and management in academic and community-based medicine required.
KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:
Extensive knowledge of oncology clinical research operations, multi-center site management in both academic and community-based oncology practice
Extensive knowledge of clinical trials study start-up/activation activities
Extensive knowledge of clinical research regulatory compliance
Excellent communication skills with the ability to interface effectively with both faculty and staff
Strong leadership skills with the ability to motivate others and drive teamwork and results
Budget management and reporting
Proficient in computer applications (Microsoft Office, including Excel and PowerPoint)
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.
Located in Boston and the surrounding communities, 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 under-served members of our community; and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.