Assistant Clinical Research Manager - Breast Oncology Clinical Trials

Clinical Trials Operations

• Assists the Clinical Research Manager with the oversight of their disease group’s clinical trial portfolio and all related regulatory and compliance requirements.
• Assists with the oversight of study start up, active and close out activities for the group’s portfolio.
• Aids in the required tracking of all protocol development, submission, review and approval milestones.
• Assists with the oversight of subject enrollment, protocol treatment and follow-up care processes for protocol patients.
• Aids in the oversight of registration of protocol patients, study group registrar, and pharmaceutical company as outlined in protocol.

Regulatory & Compliance

• Aids in the responsibility for essential document compliance for the entire portfolio.
• Implements systems to monitor and ensure regulatory document collection and maintenance compliance.
• Aids in the responsibilities for all clinical trial reporting requirements; safety event, annual approval, deviations etc.
• May implement systems to monitor portfolio compliance.

Data Management & Clinical Trial Monitoring

• Aids the CRM with responsibility for data management and compliance for the 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.
• Helps to implement corrective action to maintain data compliance when necessary.
• SUBMITS REQUIRED “PROGRESS / TRACKING” REPORTS TO KEY STAKEHOLDERS, WHEN APPLICABLE.

Staff Training & Development

• Aids the CRM with the recruitment and oversight of coordinator staff and ensures that staff have completed mandatory training in a timely manner.
• Helps implement program specific on-boarding and orientation process and may participate in annual performance evaluations and competency assessments of research staff as needed.

Knowledge, Skills, and Abilities Required

• Must be able to perform day-to-day responsibilities independently with minimal supervision from managers.
• Has the ability to identify regulatory scenarios that require consultation.
• Has a good understanding of clinical trials start-up, active and close out phases.
• Has a good understanding of clinical research, local policy and federal regulation.
• Knowledge of cancer as a disease process, cancer treatment modalities, and the clinical trial process.
• In addition, has experience in protocol development, data compilation and analysis.
• The ACRM will have a good understanding of the various tracking systems used to ensure timely data management by the clinical research staff.
• They will also understand 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.

Minimum Job Qualifications

• Bachelor’s Degree required,
• Minimum of 3 plus years of related experience preferred.
• Must have the ability to function independently, think critically and with good professional judgment.

Supervisory Responsibilities

• No direct report
• Will provide day to day supervision for study management staff, including clinical research coordinators, students, volunteers, and other research assistants as needed.

Patient Contact

• May have contact with patients of all ages and populations.

Pay Range

$70,000.00 - $85,300.00