Senior CRA
Core
Conduct site qualification, initiation, monitoring, and close-out visits to ensure patient safety, data integrity, and protocol compliance in clinical trials.
Role type
Senior Clinical Research Associate (CRA)
Builds
Clinical research programs for pharmaceutical and biotechnology sponsors
Domain
Life Sciences / Clinical Research
Required skills
GCP, ICH guidelines, regulatory requirements, patient recruitment, study start-up, site performance metrics, risk assessment, documentation management
Preferred skills
Sponsor-dedicated or cFSP environment experience, patient retention strategies
Technologies
Investigator Site Files (ISF), Trial Master Files (TMF)
Responsibilities
Conduct site qualification, initiation, monitoring, and close-out visits; Ensure investigational sites maintain high standards of patient safety and data integrity; Build and maintain effective relationships with investigators and site personnel; Monitor study progress, including regulatory documentation and patient recruitment; Collaborate with sites to implement patient recruitment and retention strategies; Maintain accurate, complete, and inspection-ready study documentation; Identify, assess, and escalate study risks and quality concerns; Mentor and support junior clinical team members.
Seniority
Senior, hands-on IC
