Clinical Research Associate (IVD)

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

• Participate in the identification, recruitment, and evaluation of clinical studies and investigators.
• Serve as the primary point of contact for clinical study sites throughout ongoing clinical studies.
• Conduct site monitoring visits and prepare reports for study initiation, monitoring, and close-out visits.
• Assist in the drafting or review of clinical study protocols, supporting plans, and procedures, including informed consent forms, monitoring plans, and data collection forms in collaboration with study project teams.
• Assist with Institutional Review Board (IRB) submissions.
• Manage trial master files, budgets, and agreements for assigned studies.
• Train site staff on protocol requirements, source documentation, EDC system, and case report form completion.
• Monitor and analyze clinical study data and report on performance.
• Assists in resolving any issues to ensure compliance with site file audits.
• Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through monitoring visits.
• Reviews the quality and integrity of the clinical data through review of eCRF data and on-site source verification.
• Works with sites to resolve data queries.
• Ensures all study deliverables are completed per study timelines.
• Performs other duties, as requested

Qualifications

• Bachelor's degree in scientific discipline or health care preferred
• Must have direct experience working in In Vitro Diagnostics (IVD) clinical studies.
• Must have at least 2 years of clinical study monitoring experience.
• Strong organizational and communication skills, required.
• Certified Clinical Research Associate (CCRA) or similar certification, preferred.

Requirements

• Demonstrated experience applying clinical research regulatory requirements, such as Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and HIPAA guidelines.
• Positive and flexible team-player.
• Strong working knowledge of IRB guidelines and Common Rule.
• Ability to manage competing priorities and drive initiatives without compromising quality.
• Excellent written, verbal, and formal presentation skills.
• Strong understanding of IVD required.
• Up to 50% travel.

Pay

• Up to $125k OTE including attractive variable compensation program.
• Employee Stock Options.

Benefits

• Medical, Dental, and Vision Insurance.
• Health Reimbursement Account (HRA)
• Flexible Spending (FSA) / Dependent Care Accounts (DCA)
• Short and Long-Term Disability
• Group Term Life Insurance
• 401(k) with Safe Harbor Match
• Unlimited PTO
• 13 Paid Holidays

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.

We invite you to apply if you have an interest in learning more about MDC and joining our mission to provide diagnostic innovators with the exceptional support and personalized solutions they need to make our world a healthier place.