Experienced Clinical Research Associate
Core
Conduct on-site clinical monitoring visits for medical therapeutics development in rare diseases, cell and gene therapy, and other areas.
Role type
Clinical Research Associate (CRA)
Builds
Clinical trial data and regulatory compliance for biotechnology, pharmaceutical, and medical device companies
Domain
Clinical Research / Healthcare
Deliverable
physical/clinical work
Required skills
Source document verification, case report form review, regulatory document review, study drug inventory management, adverse event reporting, patient recruitment assessment, clinical research methodologies, medical terminology
Preferred skills
Registered Nurse, Dietician, Pharmacist, Research Assistant background, experience leading CRA activities, mentoring junior colleagues
Technologies
Clinical trial management systems (implied by source document/CRF review)
Responsibilities
Conduct pre-study, initiation, monitoring, and closeout visits for research sites; Perform source document verification and case report form review; Perform regulatory document review; Conduct study drug inventory; Perform adverse event and serious adverse event reporting and follow-up; Assess patient recruitment and retention; Lead CRA activities if eligible; Mentoring and training Junior colleagues if eligible.