Cra III / Scra I
Core
Conduct site feasibility, initiation, and monitoring visits to ensure clinical trials adhere to protocols and ICH GCP guidelines.
Role type
Senior Clinical Research Associate (CRA III / SCRA I)
Builds
Clinical trial operations for biotech and pharmaceutical companies
Domain
Clinical Research / Biopharma
Deliverable
client delivery
Required skills
ICH GCP compliance, site monitoring, data query resolution, TMF management, adverse event reporting, study document development
Preferred skills
Lead CRA experience, mentoring junior staff, audit participation
Technologies
Case Report Forms (CRF), Investigator Site Files (ISF)
Responsibilities
Conduct Pre-Study, Study Initiation, Interim, and Close-out visits; monitor source data and Investigational Product accountability; raise and resolve data queries; collect and file TMF documentation; report Serious Adverse Events; mentor less experienced staff.
Seniority
Senior, hands-on IC