As a Clinical Research Associate you will serve as the pivotal link between clinical studies and robust clinical data. You’ll lead efforts to identify, evaluate, and establish clinical study sites for in-vitro diagnostic medical devices.

You have an opportunity to play a crucial role in making the latest diagnostic tests and devices available quickly and safely to clinicians and their patients. At MDC Associates, that’s our mission, and we need you to help us meet the growing demand for better clinical tools.

Responsibilities

• Identify, evaluate, and lead the implementation and coordination of clinical studies
• Serve as the point of contact for study participants throughout IVD medical device studies
• Conduct site monitoring visits and prepare reports for study initiation, monitoring, and close-out visits
• Draft 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, and case report form completion
• Assist with the development of study databases for managing clinical data
• Monitor and analyze clinical study data and report on performance

About MDC

For over 30 years, MDC has helped innovators and entrepreneurs bring in vitro diagnostics (IVD) and medical devices to market and impact the lives of millions of patients worldwide. Our mission is to continue to support these innovators by applying our expertise in Regulatory Affairs, Quality Systems, Training, and other consulting services to help them launch new advances that promote and protect our global and local community’s health. Learn more at www.mdcassoc.com.

By joining MDC, you will experience opportunities to grow your skillset and advance your career in a culture where we value everyone and know that our success is tied to yours. Take the next step to explore an opportunity with MDC by applying for this position.

Qualifications

• Bachelor’s degree in health care or other scientific discipline or educational equivalent
• 2+ years of relevant clinical study experience in the medical devices or pharmaceuticals industries (experience with in-vitro diagnostic devices preferred)
• ACPR or similar certifications are preferred but not required
• Demonstrated experience applying clinical research regulatory requirements, such as Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and HIPAA guidelines
• Strong understanding of U.S. Food and Drug Administration (FDA) laws and guidance on clinical studies
• Strong working knowledge of IRB guidelines and Common Rule
• Ability to manage competing priorities and drive initiatives without compromising quality
• Ability to communicate information from complex sources and present options/solutions to multiple stakeholders and diverse teams
• Excellent organizational, problem-solving, and time-management skills
• Proficiency across the Microsoft Office Suite
• Attention to detail and accuracy in work

Equal Opportunity Employer

MDC Associates, Inc. is an Equal Opportunity Employer committed to a diverse workforce. MDC Associates, Inc. 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.

Travel Requirements

20-50% estimated travel includes:

• Study sites and clinical study management
• Meetings with regulatory agencies
• Scientific, medical, and industry meetings and conferences
• International travel as needed

Reports To

Senior Clinical Affairs Scientist

Location

In-Office (Beverly, Massachusetts)
Remote-eligible

Our offices are within easy walking distance from the Beverly Depot, allowing for a green commute from Boston and the North Shore (Newburyport and Rockport lines).

Pay and Benefits

MDC Associates, Inc offers competitive salaries and benefits, including health/dental, HRA, and 401k with a match. We also support an engaging work environment that provides everyone with the opportunity and structure to learn and grow.

• Salary + Bonus
• Medical, Dental, and Vision Insurance
• Flexible Spending / Dependent Care Accounts
• Short and Long-Term Disability
• Group and Voluntary Term Life Insurance
• 401(k) with Match Potential
• Flexible Paid/Sick Time Policy