FSP Sr Clinical Research Associate I
Core
Senior Clinical Research Associate responsible for the preparation, initiation, monitoring, and closure of clinical study sites to ensure compliance with ICH-GCP and local regulations.
Role type
Senior Clinical Research Associate (IC)
Builds
Clinical trials for pharmaceutical and biotech companies
Domain
Clinical Research / Life Sciences
Deliverable
physical/clinical work
Required skills
Independent monitoring, site selection support, regulatory maintenance, training of investigators, source data verification, adverse event reporting, supply management, audit preparation, risk assessment
Preferred skills
Therapeutic expertise, international travel, driving license
Technologies
CTMS, eTMF
Responsibilities
Initiate, monitor, and close study sites; perform source data reviews and case report form reviews; manage study supplies and drug accountability; ensure inspection readiness and compliance with ICH-GCP; report serious adverse events; prepare monitoring visit reports; support audits and regulatory inspections.
Seniority
Senior, hands-on IC