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Premier Research · 1 month ago

Senior Clinical Research Associate (Contract)

Regional_NC

Full-time, Contract

Hybrid

Senior Level

5+ years exp

Premier Research is looking for a Senior Clinical Research Associate (Contract) to join our Functional Services Provider (FSP) team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics.

BiopharmaBiotechnologyHealth CarePharmaceutical

Responsibilities

Conducts source verification by comparing data recorded on Case Report Forms against source documents, verifying Informed Consent Forms for accuracy and completeness, and reviewing regulatory documents and device accountability records

Issues, investigates, and resolves any data discrepancies identified during source verification activities

Ensures clear written communication to clinical sites and project team members through monitoring reports, follow-up letters, study memos, and general correspondence

Maintains thorough documentation and proper escalation of issues related to visit reports

Ensures all site personnel are appropriately trained and prepared to conduct the clinical study in accordance with the protocol and applicable regulations

Collaborates with cross-functional team members and study sites throughout all study phases

Qualification

Clinical research monitoringSite managementAnalytical skillsOrganizational skillsCustomer experienceMedical Device knowledgeCardiology knowledgeCommunication skillsTeam collaboration

Required

Bachelor degree, or international equivalent from an accredited institution, preferably in a clinical, biological, scientific, or health-related field or equivalent combination of education, training and experience

5+ years of practical experience conducting continuous independent onsite monitoring of clinical research sites as well as site management activities. Alternately, must have proven experience in all primary job functions

Proven ability to drive a successful customer experience through positive customer interactions, provision of quality and timely deliverables, and task ownership

Strong analytical and organization skills, able to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities

Ability to meet the requirement of 3 DOS (days on site)/monitoring visits; 75% travel