Senior Clinical Research Associate (Contract)

Premier Research

11d

About The Position

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. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. Your ideas influence the way we work, and your voice matters here. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Join us and build your future here.

Requirements

• 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

Nice To Haves

• Preferred Therapeutic Area: Medical Device and Cardiology
• Preferred Location: East Coast and Mid-West

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.

What This Job Offers

• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees