Senior Clinical Research Manager - Network Operations

Dana-Farber Cancer Institute•Brookline, MA

1d•Hybrid

About The Position

The Senior Clinical Research Manager (CRM) provides strategic and operational oversight of the adult medical oncology clinical trial portfolio across six regional satellite locations within the Greater Boston and Southern New Hampshire areas, including Brighton, Milford, Weymouth, Methuen, Foxborough, MA & Londonderry, NH and any future satellite regional campus. The role is responsible for leading and managing the clinical research programs at these sites and for supervising the research staff engaged in the conduct of clinical trials in accordance with Good Clinical Practice, under the direction of the Principal Investigators and the Regional Campus Leadership Team. In close collaboration with the regional campus medical director, the research physician leads at each campus, and research nursing staff, the Senior CRM is responsible for the implementation and evaluation of both therapeutic and non-therapeutic clinical research activities, ensuring robust regulatory and compliance oversight. The Senior CRM provides direct supervision and professional development for the program’s clinical research staff and is responsible for monitoring and achieving clinical trial performance benchmarks, including protocol and regulatory compliance, patient safety, staff training and development, and financial targets, as defined by Senior Research Leadership and the Regional Campus Leadership Team. This position’s work location is primarily onsite traveling to DFCI regional sites in Brighton, Milford, Weymouth, Methuen, Foxborough, MA & Londonderry, NH, and any future regional campus location. This role will be up to 1 day remote per week. The selected candidate may only work remotely from a New England state (ME, VT, NH, MA, CT, RI). The individual selected for the position will be required to have regular presence across the regional locations and be available to work onsite at various campuses throughout the work week. 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.

Requirements

Bachelor’s Degree required, with a minimum of 7+ years of related experience or Master Degree with 5+ years experience.
Knowledge of cancer as a disease process, cancer treatment modalities, and the clinical trial process.
Experience in protocol development, data compilation and analysis.
Skilled at developing tracking systems to ensure timely data management by the clinical research staff.
Expert knowledge of Federal and State regulations as they relate to research.
Strong interpersonal, organizational and communication skills are required.
Must have computer skills including the use of Microsoft Office and working knowledge of Livelink; EPIC and OnCore applications.
Has expert knowledge of and is fully proficient in ability to execute clinical trials start-up, active and close out phases.
Is fully proficient in their knowledge of clinical research local policy and federal regulation.
Strong ability to independently navigate complex personnel issues in collaboration with key stakeholders.
Can navigate and or interpret complex regulatory strategy and can operationalize when applicable with little or no supervision.
Operates proactively to maintain compliance and best practice.
Able to problem solve and work collaboratively with key stakeholders.
May be asked to provide in-service training and can to serve as a resource to other clinical personnel including physicians, nurses, pharmacists and other allied health professionals regarding clinical trials, protocols, GCP guidelines, federal regulations and site SOPs.

Responsibilities

Responsible for the oversight of their disease group's clinical trial portfolio and all related regulatory, compliance and performance metrics requirements.
Oversee the processing of protocols through DFCI Institutional Review Board (and other institutions' IRBs) when appropriate.
Collaborate with the DFCI Clinical Trials Office (CTO), the Office for Human Research Studies (OHRS) and the Quality Assurance for Clinical Trials (QACT) to fulfill local and federal requirements governing human clinical trials.
Identify and manage operational, logistical, and regulatory challenges related to the conduct of clinical trials and acts as a leader in overseeing their resolution.
Assist the principal investigator in developing the protocol budget, in collaboration with Research Administration and the Grants and Contracts offices. Work with grant managers and other financial managers in the reporting and accounting of these funds.
Oversees and coordinates the purchase, receipt, inventory and distribution of equipment utilized in the conduct of clinical trials.
Work collaboratively with clinical research administration and grant managers to help monitor and reconcile all study and related grant finances as needed.
Assists the principal investigator in preparing manuscripts for publication.
Collaborate with the DFCI CTO and DF/HCC QACT to develop study forms, database information, and to establish guidelines for monitoring data quality control for PI Initiated studies / Multi-Center Trials
Oversee the subject enrollment, protocol treatment and follow-up care processes for protocol patients.
Oversees registration of protocol patients with QACT, study group registrar and pharmaceutical company as outlined in protocol.
Assumes responsibility for essential document compliance for entire portfolio.
Implements systems to monitor and ensure regulatory document collection and maintenance compliance.
Assumes responsibilities for all clinical trial reporting requirements; safety event, annual approval, deviations etc.
Implements systems to monitor portfolio compliance.
Responsible for the disease group's transition from paper to electronic regulatory binders.
Will maintain per DFCI CTO standards.
Assumes responsibilities 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.
Implements corrective action to maintain data compliance when necessary.
Submits required "progress/tracking" reports to key stakeholders, when applicable.
Responsible for the recruitment and oversight of all of the research staff.
Ensure that all staff complete required mandatory and ongoing training in a timely manner. Develops and oversees a program specific on-boarding and orientation process and conducts annual performance evaluations and competency assessments of research staff.
Develops a standard supervision schedule with research staff including periodic individual and group supervision meeting.
Will develop and agenda, take attendance and document all applicable meetings.
Will communicate all personnel concerns to their immediate supervisor and to DFCI HR partner for the appropriate response and follow up.