About this role
About the Role The Assistant Clinical Research Manager (ACRM) will work within the Breast Oncology clinical research program to assist in managing the research team and the conduct of clinical trials under Good Clinical Practice (GCP) and under the Principal Investigator. They will collaborate with the program’s Clinical Research Managers physicians and research nursing staff to design, implement, and evaluate clinical research activities, ensure regulatory oversight, and provide day-to-day supervision of staff as needed. 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.
- Support study start-up, active conduct, and close-out activities; track protocol development, submission, review, and approval milestones.
- Oversee subject enrollment, protocol treatment, and follow-up care for protocol patients.
- Assist with registration of protocol patients, study group registrar, and pharmaceutical company as outlined in protocol.
- Regulatory & Compliance: assist in the responsibility for essential document compliance for the entire portfolio; implement systems to monitor and ensure 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.
- Data Management & Clinical Trial Monitoring: assist with data management and compliance for the entire portfolio; maintain schedules and procedures for timely data collection; regularly report data compliance status to key stakeholders; help implement corrective actions to maintain data compliance; submit required progress/tracking reports to stakeholders.
- Staff Training & Development: assist with recruitment and oversight of coordinator staff; ensure mandatory training is completed timely; help implement onboarding/orientation and participate in annual performance evaluations and competency assessments as needed. What We're Looking For
- Strong knowledge of Good Clinical Practice and the clinical trial process.
- Experience across start-up, active, and close-out phases.
- Ability to work independently with minimal supervision.
- Understanding of local policy and federal regulations related to clinical research.
- Knowledge of cancer biology, treatment modalities, and the clinical trial process; experience with protocol development, data compilation and analysis.
- Good understanding of tracking systems used to ensure timely data management; awareness of Federal and State regulations as applicable.
- Excellent communication and collaboration with investigators, research staff, and external sponsors. Nice to Have
- Not explicitly listed in the posting. Compensation & Benefits
- Salary: $70,000.00 - $85,300.00 per year
- Hybrid work arrangement with 2-3 days onsite per week