Experienced CRA (multi-sponsor, multi-therapeutic, home-based and office-based positions available)
Core
Conduct clinical monitoring visits (qualification, initiation, monitoring, closeout) at research sites to ensure compliance with protocols and regulations for medical therapeutics development.
Role type
Clinical Research Associate (CRA)
Builds
Clinical trial data integrity and regulatory compliance for biotechnology, pharmaceutical, and medical device companies
Domain
Clinical Research / Clinical Trials / Healthcare
Deliverable
client delivery
Required skills
Medical terminology, clinical patient management, drug therapy techniques, clinical research methodologies, regulatory compliance (GCP/SOPs), risk-based monitoring, adverse event reporting, patient recruitment assessment
Preferred skills
Background in nursing, dietetics, pharmacy, or science faculty
Technologies
Integrated Clinical Trial Management System
Responsibilities
Conduct qualification, initiation, monitoring, and closeout visits at research sites; Verify investigator qualifications, training, and resources; Review medical records and source documentation against case report forms; Perform on-site and virtual monitoring with risk-based approach; Verify subject eligibility; Review regulatory documents; Manage medical device and investigational product accountability; Verify and review adverse events and concomitant medications; Assess patient recruitment and retention success; Complete monitoring reports and follow-up letters.
Seniority
Mid-level, independent execution