The Assistant Clinical Research Manager (ACRM) supports clinical research programs and teams across Dana-Farber’s regional satellite locations. Working under the direction of Principal Investigators and in collaboration with Clinical Research Managers, physicians, and research nursing staff, the ACRM helps oversee the conduct of clinical trials in accordance with Good Clinical Practice. Key responsibilities include supporting the design, implementation, and evaluation of clinical research activities; assisting with regulatory oversight; and providing day-to-day supervision of clinical research staff as needed.
This position requires weekly travel and onsite work at various regional campuses, with the ability to work remotely up to one day per week. Remote work must be performed from a New England state (ME, VT, NH, MA, CT, or RI). Dana-Farber’s regional locations include Attleboro, Boston, Brookline, Brighton, Foxborough, Milford, Methuen, and Weymouth, Massachusetts, as well as Londonderry, New Hampshire.
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.
ROLE & RESPONSIBILITIES:
Clinical Trials Operations
Assistant Clinical Research Managers (ACRM) will be responsible for assisting the Clinical Research Manager with the oversight of their disease group’s clinical trial portfolio and all related regulatory and compliance requirements.
The ACRM will assist the CRM will all aspects of study start up, active and close out activities for the group’s portfolio. They will be responsible for the required tracking of all protocol development, submission, review and approval milestones.
The ACRM will assist with the oversight of subject enrollment, protocol treatment and follow-up care processes for protocol patients.
Assist with the oversight of registration of protocol patients, study group registrar and pharmaceutical company as outlined in protocol.
Regulatory & Compliance
Assists in the responsibility for essential document compliance for entire portfolio. Implements systems to monitor and ensure regulatory document collection and maintenance compliance.
Assists in the responsibilities for all clinical trial reporting requirements; safety event, annual approval, deviations etc. May implement systems to monitor portfolio compliance.
Assists the study team to be maintain an “audit ready” research environment
Data Management & Clinical Trial Monitoring
Assists CRM with responsibility for data management and compliance for entire portfolio. Maintains schedules and procedures necessary for timely and complete data collection.
Regularly reports data compliance status to key stakeholders; i.e. DFCI PI, study Sponsor, DFCI CTO. Helps to implement corrective action to maintain data compliance when necessary.
Submits required “progress / tracking “reports to key stakeholders, when applicable.
Staff Training & Development
Will assist the CRM with the recruitment and oversight of coordinator staff as well as ensures that staff have completed mandatory training in a timely manner.
Will help implement program specific on-boarding and orientation process and may participate in annual performance evaluations and competency assessments of research staff as needed.
KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:
Must be able to perform day-to-day responsibilities independently with minimal supervision from…