Assistant Clinical Research Manager - Center of Early Detection & Intervention Blood Cancers Interventional Clinical Trials

About the Role The Assistant Clinical Research Manager (ACRM) will work within the Center of Early Detection & Intervention Blood Cancers (CEDI BC) Interventional Clinical Trials program and assist in the management of the research team to conduct clinical trials under Good Clinical Practice, under the auspices of the Principal Investigator. In collaboration with the program’s Clinical Research Managers, physicians, and research nursing staff, the ACRM assists with the design, implementation, and evaluation of the program’s clinical research activities and regulatory oversight, and provides day-to-day supervision of the program’s clinical research staff as needed. This hybrid role includes on-site and remote work; the selected candidate may only work remote days from New England states. What You'll Do

• Assist the Clinical Research Manager with oversight of the disease group’s clinical trial portfolio and all related regulatory and compliance requirements.
• Help manage study start-up, active, and close-out activities for the group’s 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, study group registrar, and pharmaceutical company as outlined in the protocol.
• Regulatory & Compliance: assist in essential document compliance for the portfolio; implement systems to monitor regulatory document collection and maintenance compliance; assist in responsibilities for all clinical trial reporting requirements (safety events, annual approvals, deviations); may implement systems to monitor portfolio compliance; maintain an audit-ready research environment.
• Data Management & Clinical Trial Monitoring: assist the CRM with data management and compliance for the portfolio; maintain schedules and procedures for timely and complete data collection; regularly report data compliance status to key stakeholders (PI, Sponsor, CTO); help implement corrective action to maintain data compliance; submit required progress/tracking reports to stakeholders when applicable.
• Staff Training & Development: assist with recruitment and oversight of coordinator staff; ensure mandatory training is completed in a timely manner; help implement program-specific onboarding and orientation; participate in annual performance evaluations and competency assessments of research staff as needed. What We're Looking For
• Ability to perform day-to-day responsibilities independently with minimal supervision from managers.
• Ability to identify regulatory scenarios that require consultation.
• Strong understanding of clinical trials start-up, active, and close-out phases.
• Strong understanding of clinical research, local policy and federal regulation.
• Knowledge of cancer as a disease process and cancer treatment modalities. Compensation & Benefits
• Salary: $70,000.00 - $85,300.00 per year.