Assistant Clinical Research Manager - Pediatric Cancer Predisposition Program

Dana-Farber Cancer Institute

  • Boston, MA
  • Permanent
  • Full-time
  • 25 days ago
ResponsibilitiesClinical Trials Operations
  • Assistant Clinical Research Managers (ACRM) will be responsible for assisting the Clinical Research Manager with the oversight of their disease group’s clinical trial portfolio and all related regulatory and compliance requirements.
  • The ACRM will assist the CRM will all aspects of study start up, active and close out activities for the group’s portfolio. They will be responsible for the required tracking of all protocol development, submission, review and approval milestones.
  • The ACRM will assist with the oversight of subject enrollment, protocol treatment and follow-up care processes for protocol patients.
  • Assist with the oversight of registration of protocol patients, study group registrar and pharmaceutical company as outlined in protocol.
Regulatory & Compliance
  • Assists in the responsibility for essential document compliance for entire portfolio. Implements systems to monitor and ensure regulatory document collection and maintenance compliance.
  • Assists in the responsibilities for all clinical trial reporting requirements; safety event, annual approval, deviations etc. May implement systems to monitor portfolio compliance.
  • Assists the study team to be maintain an “audit ready” research environment
Data Management & Clinical Trial Monitoring
  • Assists CRM with responsibility 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. Helps to implement corrective action to maintain data compliance when necessary.
  • Submits required “progress / tracking “reports to key stakeholders, when applicable.
Staff Training & Development
  • Will assist the CRM with the recruitment and oversight of coordinator staff as well as ensures that staff have completed mandatory training in a timely manner. Will help implement program specific on-boarding and orientation process and may participate in annual performance evaluations and competency assessments of research staff as needed.
QualificationsAt 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.
  • Bachelor's Degree required.
  • Minimum of 3-5 years of related experience preferred.
  • Experience in protocol development, data compilation and analysis.
  • Must be able to perform day to day responsibilities independently with minimal supervision from manager.
  • 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.
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.

Dana-Farber Cancer Institute