Clinical Research Associate - IVD

October 1

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MDC Associates, Inc.

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regulatory • diagnostics • point of care • FDA • IVDR

11 - 50

Description

• MDC Associates is a full-service CRO focusing on In Vitro Diagnostics (IVD) and Medical Devices. • The Clinical Research Associate conducts site qualification, initiation, monitoring, and close-out visits. • Ideal candidate possesses strong understanding of IVD clinical studies and Good Clinical Practices.

Requirements

• 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. • 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.

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