Job Description
MDC Associates ("MDC") is a full-service CRO dedicated to supporting innovators and entrepreneurs bringing In Vitro Diagnostics (IVD) and Medical Devices to market that impact the lives of millions of patients around the world. Initially founded to provide Regulatory and Quality guidance, we identified a need for highly skilled Clinical Affairs, Clinical Operations, and Data Management services and built our CRO to best ensure our client's success. We're proud of our 35+ year track record providing guidance and resources that have helped to deliver next-generation advances in microbiology, clinical chemistry, infectious disease and companion diagnostics (CDx) that contribute to a healthier world.
The Clinical Research Associate is highly motivated and organized individual with a proven history executing IVD clinical studies. The CRA will be tasked to conduct site qualification, site initiation, interim monitoring and close out visits to clinical sites. The ideal candidate will have a keen understanding of the nuances of IVD clinical studies and will conduct all clinical trials in accordance with Good Clinical Practices and study protocol requirements.
Primary Responsibilities
- 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.
Qualifications
- 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.
Knowledge and Skills
- 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.
Travel Requirements
- Up to 75% travel including local, within U.S and outside of the US. Travel may include:
- Attending clinical site Initiation, interim and close out monitoring visits
- Attending annual industry conferences (i.e.: Association of Clinical Research Professionals)
Pay
- Compensation commensurate with experience.
- Employee Stock Options
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
Equal Opportunity Employer
MDC is an Equal Opportunity Employer committed to a diverse workforce. MDC 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.