Clinical Research Associate

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November 15

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MDC Associates, Inc.

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Healthcare Insurance • Biotechnology • Science

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.

11 - 50 employees

Founded 1993

⚕️ Healthcare Insurance

🧬 Biotechnology

🔬 Science

📋 Description

• 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.

🎯 Requirements

• BA, BS, or Master’s degree in Life Sciences, Data Science, Statistics, or a related field (preferred). • 2+ years’ relevant clinical study experience in the medical devices industry or pharmaceuticals industry with specific experience in in vitro diagnostic devices a plus. • ACRP or similar certification a plus but not required. • In depth knowledge of, and experience in applying, applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP), International Conference on Harmonisation (ICH), and HIPAA guidelines. • Understanding of U.S. Food and Drug Administration (FDA) laws and guidance pertaining to clinical studies. • Understanding of IRB guidelines and Common Rule. • Computer skills including proficiency in use of Office 365, Microsoft Word, Excel, Access, Outlook and PowerPoint. • Strong written and verbal communication skills including good command of English language. • Excellent organizational and problem-solving skills. • Effective time management skills. • Attention to detail and accuracy in work. • Ability to manage competing priorities without compromising quality. • Ability to establish and maintain effective collaborative relationships with coworkers, managers and clients.

🏖️ 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 • Paid Holidays