The Clinical Affairs Specialist will provide guidance to study sponsors and IVD medical device manufacturers in support of clinical study design and execution. Responsible for the development of clinical study protocols and implementation of those protocols at study sites. Develops and implements strategies in a collaborative environment between colleagues and clients with the goal of successful regulatory submissions.
Development and execution of clinical study strategies and protocols to support the validation of new medical and in vitro diagnostic devices.
Prepare and present clinical study protocols and reports for regulatory bodies including the US FDA.
Creation of Clinical and Analytical Study Protocols and supporting plans and procedures, including Informed Consent Forms (ICFs), Monitoring Plans and Data Collection Forms in conjunction with the assigned Project Team.
Assist clients in identifying and contracting with potential Clinical Trial Sites and/or Reference Laboratories.
Assist with Institutional Review Board (IRB) submissions.
Lead and manage internal and external resources to support all aspects of clinical and method comparison studies in accordance with Good Clinical Practice including site initiation, interim, and close-out monitoring visits (virtually and physically).
Monitor and analyze clinical study data and report on performance both internally and with study sponsors.
Prepare study reports to support Regulatory Filings such as FDA 510(k), de novo and PMA submissions, Health Canada Licensure, EU Technical Files, etc.
Provide input on the content of submission documents based on experience, regulations, and guidance available from regulatory bodies.
Implementation of regulatory and clinical processes as they relate to company procedures, clinical studies, testing, and documentation and ensure that they are communicated through company policies and procedures.
REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES:
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 guidelines pertaining to clinical studies.
Understanding of IRB guidelines and Common Rule.
Knowledge of the European Commission Medical and In Vitro Diagnostic Device Regulations.
Knowledge of applicable protocol requirements as provided in-company training.
Computer skills including proficiency in the use of Office 365, Microsoft Word, Excel, Access, Outlook, and PowerPoint.
Strong written and verbal communication skills including good command of the 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.
20-25% Travel including local, within the U.S and outside of the US. Travel may include:
Attending off-site client meetings
Attending clinical site Initiation and Monitoring Visits
Attending annual industry conferences
MINIMUM REQUIRED EDUCATION AND EXPERIENCE:
Minimum of a Bachelor's degree in health care or other scientific discipline or educational equivalent.
In-depth knowledge of the scientific, ethical, and regulatory foundations of clinical research
5-10 years relevant clinical study experience in the medical device or pharmaceutical industry with specific experience in in-vitro diagnostic devices a plus.
Knowledge/experience in medical or in-vitro diagnostic device product development a plus.
ACRP or similar certification a plus but not required.
About MDC Associates, Inc.
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.