Note: The job is a remote job and is open to candidates in USA. MD-Clinicals is seeking an experienced Senior Clinical Research Associate to join their Clinical Operations team in the United States. The role involves monitoring and managing medical device clinical investigations to ensure compliance with regulations and high-quality research standards.
Responsibilities
- Manage all clinical research activities for assigned investigational sites
- Perform site qualification, initiation, routine monitoring, and close-out visits according to study plans and company SOPs
- Ensure compliance with study protocols, ICH-GCP, ISO 14155, FDA regulations (21 CFR Parts 812, 50 and 56), and applicable regulatory requirements
- Prepare and coordinate IRB/Ethics Committee submissions and maintain complete and accurate essential study documentation
- Support regulatory submissions where applicable
- Review informed consent forms and assist with study document preparation and translations when required
- Maintain investigator site files and Trial Master File (TMF) documentation
- Monitor subject safety, protocol compliance, source documentation, and data quality
- Identify site issues and implement appropriate Corrective and Preventive Actions (CAPAs)
- Ensure timely safety reporting and study documentation updates
- Coordinate study-related payments and administrative activities
- Assist Project Managers with the preparation of essential study documents
- Act as Coordinating CRA for multicenter clinical investigations when required, supporting colleagues across different US regions
Skills
- Bachelor's degree in Life Sciences, Nursing, Biomedical Sciences, Pharmacy, or another relevant scientific discipline
- Significant experience as a Clinical Research Associate within the medical device industry
- Solid experience monitoring medical device clinical investigations in the United States
- Experience independently managing investigational sites from initiation through close-out
- Strong knowledge of ICH-GCP (E6)
- Strong knowledge of ISO 14155
- Strong knowledge of FDA regulations, including 21 CFR Parts 812, 50 and 56
- Strong knowledge of clinical trial processes and documentation
- Excellent communication and interpersonal skills
- Strong organizational and time management abilities
- Ability to work independently while collaborating within an international team
- Detail-oriented with excellent problem-solving skills
- Strong written and verbal English communication skills
- Willingness to travel extensively within the United States
- Valid driver's license
- Authorization to work in the United States
- Previous experience coordinating multicenter studies is considered an asset
Benefits
- The opportunity to work on innovative medical device clinical research projects.
- A collaborative and international working environment.
- Career growth and professional development opportunities.
- Competitive compensation and benefits (for employees) or attractive project opportunities (for freelancers).
- The opportunity to make a meaningful impact on the development of technologies that improve patients' lives.
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