JOB SCOPE: Responsible for the implementation and coordination of clinical studies for IVD medical devices.
Identify, evaluate, and establish clinical study sites.
Conduct regular site monitoring visits (virtually and physically) and prepare reports for study initiation, monitoring, and close-out visits.
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) submissions.
Manage study budget and agreements with study sites.
Manage study Trial Master Files.
Train site staff on protocol requirements, source documentation and case report form completion.
Serve as point of contact with study sites during IVD medical device studies.
Attend regularly scheduled teleconference meetings with clients during study preparation and throughout studies.
Monitor and analyze clinical study data and report on performance both internally and with study sponsors.
Assist with the development of study databases for managing clinical data.
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.
Ability to learn applicable protocol requirements as provided in company training.
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.
10-25% Travel including local, within U.S and outside of the US. Travel may include:
Attending off-site client meetings
Attending clinical site Initiation, interim and close out monitoring visits
Attending annual industry conferences (i.e.: Association of Clinical Research Professionals)
MINIMUM REQUIRED EDUCATION AND EXPERIENCE:
Bachelor's degree in a health care or other scientific discipline or educational equivalent.
2+ years’ relevant clinical study experience in the medical devices industry with specific experience in in vitro diagnostic devices a plus.
ACRP or similar certification a plus but not required.
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 where we know our success is directly tied to yours. Take the next step to explore an opportunity with MDC by applying for this position.