Clinical Research Associate

MDC Associates ("MDC") is a full-service CRO dedicated to supporting innovators and entrepreneurs bringing In Vitro Diagnostics (IVD) and Medical Devices to market that impact the lives of millions of patients around the world. Initially founded to provide Regulatory and Quality guidance, we identified a need for highly skilled Clinical Affairs, Clinical Operations, and Data Management services and built our CRO to best ensure our client's success. We're proud of our 35+ year track record providing guidance and resources that have helped to deliver next-generation advances in microbiology, clinical chemistry, infectious disease and companion diagnostics (CDx) that contribute to a healthier world.

The Clinical Research Associate is highly motivated and organized individual with a proven history executing IVD clinical studies. The CRA will be tasked to conduct site qualification, site initiation, interim monitoring and close out visits to clinical sites. The ideal candidate will have a keen understanding of the nuances of IVD clinical studies and will conduct all clinical trials in accordance with Good Clinical Practices and study protocol requirements.

Primary Responsibilities

• Develop and conduct site training on protocol requirements, source documentation completion, and electronic data capture (EDC).
• Conduct regular site monitoring visits (virtually and physically) and prepare reports for study initiation, monitoring, and close-out visits.
• Ensure site adherence to study protocols and regulatory requirements.
• Draft and / or provide input into Clinical Study Protocols, supporting plans and procedures, including Informed Consent Forms (ICFs), Monitoring Plans and Data Collection Forms in conjunction with the assigned Project Team.
• Assist with Institutional Review Board (IRB) management.
• Manage study budget and agreements with study sites.
• Manage study Trial Master Files.
• Serve as primary point of contact with study sites.
• Monitor and analyze clinical study data and report on performance to the project team.
• Assist with the development of study databases for managing clinical data.

Qualifications

Knowledge and Skills

Travel Requirements

Pay

Benefits

Equal Opportunity Employer

MDC is an Equal Opportunity Employer committed to a diverse workforce. MDC will not discriminate against any worker or job applicant based on race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, gender identity, marital or civil partnership status, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, or membership in any other category protected under law.