This job has closed.

ATR International · 1 week ago

Clinical Trials Management Associates

Santa Monica, CA

Contract

Hybrid

Mid Level

$60/hr - $60/hr

4+ years exp

ATR International is seeking a Clinical Trials Management Associate for a very important client in the healthcare sector. The role involves conducting site evaluations and monitoring visits, ensuring compliance with clinical trial regulations, and coordinating with CROs and vendors.

Human ResourcesRecruitingStaffing Agency

Diversity & Inclusion

No H1B

Hiring Manager

Ashita S Shelat

Responsibilities

Must meet all requirements for Clinical Research Associate position and have demonstrated proficiency in all relevant areas. With limited supervision conducts site evaluations/initiations and closeout visits in addition to routine monitoring visits, as required:

Working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials

Assures site compliance with the routine protocol and regulatory requirements and quality of data. Assists in the setting and updating of study timelines

Assists in CRO or vendor selection

With guidance from supervisor coordinates CROs or vendors

Participate or effectively runs meetings and conference calls with CROs, vendors, and multi-functional teams (May participate in abstract presentations, oral presentations and manuscript development)

Interfaces with individuals in other functional areas to address routine study issues

Travel is required

Qualification

Clinical Trials ManagementFDA RegulationsICH GuidelinesGCP ComplianceCRO CoordinationScientific Discipline DegreeRN CertificationCCRA CertificationCommunication SkillsTeam CollaborationPresentation SkillsProblem SolvingTime Management