Clinical Research Coordinator

A Clinical Research Coordinator independently directs and manages research activities; responsible for management and coordination of numerous research studies and personnel; educate staff on project research protocols; and acts as a central resource person.

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
  • Maintain records for the receipt, dosing, administration and accountability of investigational product
  • 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
  • Oversee and direct research activities assigned to Clinical Research Assistant (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.