Assistant Clinical Research Manager - GI Oncology

Dana-Farber Cancer Institute - Boston, MA

Full-time - Mid Level

Boston, MA

Professional, Scientific, and Technical Services

About the position

The Gastrointestinal (GI) Oncology Clinical Research Program at Dana-Farber Cancer Institute is seeking an Assistant Clinical Research Manager (ACRM) to join our program. This position is integral to the management of clinical trials across multiple GI cancers, including esophageal, stomach, liver, pancreas, colon, and neuroendocrine cancers. The ACRM will work closely with the Principal Investigator and the clinical research team to ensure the successful conduct of clinical trials in accordance with Good Clinical Practice (GCP). This role is designed for new managers who may not have prior supervisory experience, providing a transition into management within a supportive environment. In this role, the ACRM will assist in the design, implementation, and evaluation of clinical research activities, ensuring compliance with regulatory requirements. The ACRM will provide day-to-day supervision of the clinical research staff and will be responsible for overseeing the clinical trial portfolio, including study start-up, active management, and close-out activities. The ACRM will also play a key role in subject enrollment, protocol treatment, and follow-up care processes, ensuring that all regulatory and compliance requirements are met. The ACRM will be involved in data management and clinical trial monitoring, maintaining schedules for timely data collection and reporting compliance status to stakeholders. Additionally, the ACRM will assist in staff training and development, ensuring that all team members are adequately trained and supported in their roles. This position offers a unique opportunity to contribute to groundbreaking cancer research while fostering an inclusive and diverse work environment.

Responsibilities

• Assist the Clinical Research Manager with oversight of the clinical trial portfolio and regulatory compliance requirements.
• Support all aspects of study start-up, active management, and close-out activities for the clinical trial portfolio.
• Track protocol development, submission, review, and approval milestones.
• Oversee subject enrollment, protocol treatment, and follow-up care processes for protocol patients.
• Assist with the registration of protocol patients and coordination with study group registrars and pharmaceutical companies.
• Work on process improvement projects within the research team as needed.
• Ensure compliance with essential documents for the entire clinical trial portfolio.
• Implement systems to monitor regulatory document collection and maintenance compliance.
• Assist with clinical trial reporting requirements, including safety events and annual approvals.
• Maintain an 'audit ready' research environment for the study team.
• Assist with data management and compliance for the clinical trial portfolio.
• Maintain schedules and procedures for timely and complete data collection.
• Report data compliance status to key stakeholders, including the DFCI PI and study sponsors.
• Implement corrective actions to maintain data compliance when necessary.
• Submit required progress and tracking reports to stakeholders as applicable.
• Assist with recruitment and oversight of coordinator staff, ensuring timely completion of mandatory training.
• Help implement program-specific onboarding and orientation processes for new staff.
• Participate in annual performance evaluations and competency assessments of research staff as needed.
• Assist in running meetings and presenting updates for the research team.

Requirements

• Bachelor's Degree required.
• Minimum of 3-5 years of related experience preferred.
• Experience in protocol development, data compilation, and analysis.
• Ability to perform day-to-day responsibilities independently with minimal supervision.
• Ability to identify regulatory scenarios that require consultation.
• Good understanding of clinical trials start-up, active, and close-out phases.
• Knowledge of clinical research local policy and federal regulations.