Clinical Research Manager

3 weeks ago

Boston, Massachusetts, United States Dana-Farber Cancer Institute Full time

The Clinical Research Manager will oversee the conduct of clinical trials within the GI Oncology clinical research program, ensuring compliance with Good Clinical Practice and regulatory requirements.

Working closely with the Principal Investigator and the Clinical Trials Office, the CRM will manage the research team, design, implement, and evaluate clinical research activities, and oversee the supervision of clinical research staff.

The CRM will be responsible for tracking and complying with clinical trial performance benchmarks, including protocol and regulatory compliance, patient safety, staff development and training, and financial goals.

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 strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds.

The CRM will collaborate with the DFCI Clinical Trials Office, the Office for Human Research Studies, and the Quality Assurance for Clinical Trials to fulfill local and federal requirements governing human clinical trials.

The CRM will identify and manage operational, logistical, and regulatory challenges related to the conduct of clinical trials and act as a leader in overseeing their resolution.

The CRM will 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.

The CRM will 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.

The CRM will 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 meetings.

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.

Bachelor's Degree required.

Minimum of 5+ years of related experience, or Master's Degree with 5 years related experience.

KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:

Must be able to perform day-to-day responsibilities independently with little or no supervision from manager.

Must have very proficient knowledge of and ability to execute clinical trials start-up, active, and close-out phases.

Must have very proficient knowledge of clinical research local policy and federal regulation.

Must efficiently identify complex regulatory scenarios, independently develop viable solutions to present to supervisor.

Must be very proficient in the ability to manage personnel issues and to provide critical feedback to supervisees, when applicable.

Must have 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.

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.

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