The Associate Director for Clinical Trials Operations will report directly to the Clinical Trails Office Senior Director.?? This position will be responsible for the overall management and oversight of the assigned Clinical Research Disease group managers. ??The Associate Director will oversee all clinical trial operations activities, will have direct supervisory responsibilities for the Clinical Research Managers, and indirect ongoing oversight of Assistant Clinical Research Managers (ACRMs), Clinical Research Coordinators (CRCs) and Research Data Specialists (RDS) within those assigned groups.
Under the direction of the DFCI CTO Senior Director, this position will collaborate and regularly meet with key stakeholders: Clinical Research Disease Center Managers, CTO Associate Directors of Regulatory Operations, Regulatory Affairs, Network and Satellite Program, Project Management / Monitoring and Education and Training to promote excellence and streamlined collaboration in clinical research across all disease groups. ??This position will be expected to meet with Disease Center Clinical Research Directors on a regular basis to solicit feedback, discuss initiatives and review study team performance.
The Associate Director for Clinical Trials Operations will ensure compliance with all regulatory policies and guidelines including federal, state, local, as well as the policies and procedures outlined by DFCI and the Dana-Farber Harvard Cancer Center (DF/HCC) consortium.
This position is 2-3 days remote. Only applicants living in Massachusetts, Rhode Island, or New Hampshire at the time of employment will be considered. Candidates must have the ability to work from our Boston, MA office for onsite days.??
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.
Clinical Trials Operations ??? Overall Management
Meet regularly with CRMs and ACRMs to review ongoing clinical trials activities: day to day protocol conduct execution adherence and to serve as the point person to resolve real time issues / conflicts that may prevent protocol conduct execution and or compliance. ??
Responsible for the ensuring CRMs and ACRMs provide the required oversight, review, and regular monitoring of CRC / RDS workload distribution.
Work with key stakeholders to identify, collaborate and resolve issues interfering with abilities to meet operational goals; specifically with regard to protocol / amendment activation activities.
Partner with CTO Sr. Director and other key stakeholders to collaborate with lead Industry Partners to enhance productive relationships to support common goal outcomes.
Report defined KPI progress to CTO Sr. Director on a regular basis; identify barriers and solutions to meet goals.??
Clinical Trials Operations ??? Compliance
Oversee, track and report on assigned Disease Groups compliance KPIs; overall protocol compliance, safety reports, SAE, Deviation reporting, kit / sample collection adherence, etc.
Oversee, track and report on monitoring and audit findings, reports, and corrective actions (CAPA) progress / compliance.
Ensure assigned disease groups are implementing the most up to date DFCI, DF/HCC and all relevant regulatory authority SOPs and regulations.??
Clinical Trials Operations - Best Practices ??
Lead and implement standardized best practices and process improvements across assigned research disease groups.
Point contact for all protocol sponsors to resolve clinical trial conduct issue and to ensure efficient clinical trial conduct and management across assigned disease groups.
Serve as point person to ensure operational workflows are followed; protocol scheduling, patient reimbursements, Y2 / Materials Management (kit coordination and specimen collection), and applicable pharmacy activities.
Clinical Trials Operations - ??Staff Hiring, Supervision, Training and Development
Hire, train and provide supervision to all Clinical Research Managers and Assistant Clinical Research Managers when applicable.
Assist Clinical Research Managers and Assistant Clinical Research Managers with hiring, training and supervision of their clinical research operations staff when needed.
Report quarterly analysis on significant trends in hiring, training, and supervision; including action plans to address.
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.
Bachelor's degree in a field relevant to research compliance and 7 years of progressively responsible experience with conducting and managing clinical trials.
A Master's degree or higher with 5 years of progressively responsible experience managing clinical trials and experience with metrics tracking and analysis is highly desirable.
Experience in an academic institution is highly preferred, especially working in collaborative efforts with upper administrators, faculty, and research staff as well as research support personnel.??
Must have expertise in research ethics and the responsible conduct of research.
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 groups as 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.