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.
As a Clinical Trial Assistant you will support the Regulatory and Clinical Affairs team, contributing to the successful planning, management, and execution of clinical trial projects. This is your opportunity to acquire foundational experience in clinical research and start your path of growth in the Clinical Research Organization at MDC. Join our fast-growing team as we scale up to meet the increasing demand of the medical diagnostics industry.
- Execute clinical trial project tasks in support of the Regulatory and Clinical Affairs team
- Review, track, and archive project records and assist with preparation of study reports
- Coordinate ordering and distribution of trial materials in accordance with study contracts and protocols
- Track and confirm inventory levels of trial materials at study sites and report potential issues
- Assist with data entry and tracking
- Provide general administrative support to the Regulatory and Clincal Affairs team
- Additional duties as required
- Associates degree or two years of relevant academic or work experience (scientific or healthcare industries preferred)
- Ability to exercise discretion and good judgement when handling confidential information
- Willingness to learn and comply with U.S. Food and Drug Administration regulations, International Conference on Harmonisation (ICH), Good Clinical Practice (GCP), and HIPAA guidelines
- Excellent organizational, problem-solving, and time management skills
- Strong written and verbal communication skills
- Proficiency across the Microsoft Office Suite
- Ability to manage competing priorities and drive initiatives without compromising quality
- Self-driven team player with demonstrated ability to work independantly and collaboratively
- Ability to adapt to change in a fast-paced, multi-disciplinary team setting
- Attention to detail and accuracy in work
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 around the world. 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 communities’ 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.
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.
Minimal to no travel expected
Regulatory and Clinical Affairs Manager
In-Office: Beverly, Massachusetts
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 the opportunity and structure to learn and grow.