Internal Clinical Research Associate (East Coast Remote)
About The Position
Selution, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs. Based on the U.S. East Coast, the Internal Clinical Research Associate (iCRA) is responsible for day-to-day management and oversight of assigned global clinical trial sites for sponsor-led medical device studies. The role focuses on proactive site management, site performance oversight, follow-up compliance, data quality, inspection readiness, and support of clinical trial execution in compliance with study protocols, Good Clinical Practice (GCP), and applicable regulatory requirements. The individual acts as the primary operational contact for assigned sites and works closely with Clinical Study Managers, Data Management, Monitoring, and cross-functional teams to ensure timely and high-quality study execution. The iCRA plays a critical role in ensuring high-quality clinical trial execution through proactive site oversight and operational support. The role contributes directly to data quality, patient follow-up compliance, protocol adherence, and inspection readiness, thereby supporting successful study execution, database lock timelines, regulatory submissions, and overall credibility of the clinical program.
Requirements
- Must be based on the U.S. East Coast
- Minimum requirement of a Bachelor's degree in Life Sciences or related field.
- Minimum 3-5 years of experience in the medical device sector, preferably in a CRO or Sponsor setting.
- Experience in site management and oversight of global clinical trial sites is required.
- Strong understanding of ICH-GCP guidelines and FDA regulatory requirements.
- Strong organizational and prioritization skills with the ability to manage multiple sites and competing timelines.
- Excellent communication and relationship management skills.
- Strong attention to detail and proactive problem-solving mindset.
- Ability to independently drive site follow-up and operational issue resolution.
- Ability to work cross-functionally and collaboratively across global teams.
- Comfortable working across multiple time zones, including the US, Europe and Asia.
- Strong sense of accountability and ownership.
- US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
Nice To Haves
- Experience supporting FDA-regulated IDE clinical trials is strongly preferred.
- Experience with FDA BIMO inspections, audit preparation, or inspection readiness activities is highly desirable.
- Experience in peripheral vascular clinical studies is preferred.
Responsibilities
- Serves as the primary sponsor contact for assigned clinical trial sites and maintains regular communication with investigators and study coordinators.
- Proactively manages site performance, including patient recruitment, follow-up compliance, data entry timeliness, query resolution, source document collection, and protocol compliance.
- Performs monthly data deep dives to support Data Management cleaning activities.
- Tracks and escalates site-related risks, protocol deviations, delayed visits, missing data, and quality concerns to the Clinical Study Manager and Clinical Director.
- Collaborates closely with Monitors, Data Management, Safety, Core Labs, and vendors to ensure timely issue resolution and high-quality study conduct.
- Supports inspection readiness activities, including preparation for FDA BIMO inspections, audits, and internal quality reviews.
- Reviews site documentation and study data for completeness, consistency, and protocol compliance.
- Supports and oversees site activation activities, including site initiation visits, study trainings, and ongoing retraining activities as needed.
- Supports the collection and review of essential documents, regulatory documentation, and site-level study records.
- Contributes to continuous process improvements related to site management, follow-up compliance, data quality, and operational oversight.
- Ensures adherence to company SOPs, ICH-GCP guidelines, applicable regulatory requirements, and study-specific procedures.
Benefits
- The expected pre-tax pay rate for this position is $71,500 - $96,000 per year.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
