MDC Associates, Inc.
MDC Associates, Inc. is a trusted partner for Contract Research Organization (CRO) services, specializing in Data Management, Regulatory Affairs, and Quality Systems in the In Vitro Diagnostics (IVD) industry. The company offers comprehensive support for clinical studies, regulatory audits, quality management, and IVD market clearance, focusing on microbiology, clinical chemistry, infectious diseases, and diagnostic technologies. MDC Associates collaborates with startups, growing businesses, and established companies, providing tailored strategies, quality system development, regulatory guidance, and global network access. With over 35 years of expertise and a strong relationship with the FDA, they guide IVD makers through market clearance processes effectively and ensure compliance with regulatory standards.
regulatory • diagnostics • point of care • FDA • IVDR
Clinical Research Associate - IVD
April 3
MDC Associates, Inc.
MDC Associates, Inc. is a trusted partner for Contract Research Organization (CRO) services, specializing in Data Management, Regulatory Affairs, and Quality Systems in the In Vitro Diagnostics (IVD) industry. The company offers comprehensive support for clinical studies, regulatory audits, quality management, and IVD market clearance, focusing on microbiology, clinical chemistry, infectious diseases, and diagnostic technologies. MDC Associates collaborates with startups, growing businesses, and established companies, providing tailored strategies, quality system development, regulatory guidance, and global network access. With over 35 years of expertise and a strong relationship with the FDA, they guide IVD makers through market clearance processes effectively and ensure compliance with regulatory standards.
regulatory • diagnostics • point of care • FDA • IVDR
📋 Description
• 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.
🎯 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.
🏖️ 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
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