Clinical Research Assistant

A Clinical Research Assistant will support clinical operations and work as a team with the Clinical Research Coordinator (CRC) to support clinical study conduct.

Essential Job Functions:

  • Conduct and oversee assigned clinical trials in compliance with protocol, GCP guidelines and FDA regulations
  • Conduct consent discussions and obtain informed consent as delegated by the Principal Investigator
  • Act as primary contact between investigator, agencies, sponsoring companies, subjects, and vendors
  • Conduct study assessments and procedures as delegated including (but not limited to) efficacy and safety assessments
  • Facilitate routine monitoring visits, sponsor visits, and sponsor audits
  • Perform eCRF/CRF completion and query resolution
  • Manage study subject visits
  • Work with regulatory, recruitment, and laboratory staff to ensure compliance with study guidelines and conduct
  • Does not maintain records for the receipt, dosing, administration and accountability of investigational product; may assist with IP verification as needed
  • Other duties as assigned

Knowledge, Education, and Experience:

  • Bachelor’s Degree preferred or related experience
  • Knowledge of FDA, GCP, ICH, and other state and federal agency guidelines
  • Knowledge of HIPAA Privacy Act and its application to clinical research
  • Knowledge of IRB requirements

Job Category: Clinical

Job Type: Full Time

Job Location: BerlinMarlton

Apply for this position

  • Accepted file types: pdf, doc, docx, Max. file size: 150 MB.
  • This field is for validation purposes and should be left unchanged.