Senior Clinical Research Associate - Cardiovascular Medical Device
V
VahatiCorCardiovascular Medical Devices
Remote position supporting clinical sites throughout the Eastern United States, Eastern or Central time zoneFull-TimeSenior
Salary$113,000 - $153,000
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Job Details
- Experience
- 7+ years of clinical research experience
- Required Skills
- GCP
Requirements
- Bachelor’s degree in Life Sciences, Nursing, Biomedical Engineering, or a related scientific discipline.
- 7+ years of clinical research experience supporting medical device clinical trials.
- Proven sponsor-side medical device clinical research experience.
- Prior clinical operations experience within an early-stage medical device company.
- Demonstrated experience owning clinical study startup, site activation, patient enrollment, and clinical trial execution.
- Experience owning site qualification, Site Initiation Visits (SIVs), and clinical trial monitoring.
- Deep understanding of Good Clinical Practice (GCP), FDA medical device regulations, and clinical research operations.
- Ability and willingness to travel up to 60% for site activities.
- Strong organizational, relationship-building, and problem-solving skills.
- Excellent written and verbal communication skills.
Responsibilities
- Lead site qualification, feasibility, and readiness activities for assigned cardiovascular medical device clinical trial sites.
- Own clinical study startup and site activation activities, including collection and review of essential regulatory and startup documentation.
- Serve as the primary operational contact for assigned cardiovascular clinical trial sites.
- Drive patient screening and enrollment activities to achieve study recruitment goals.
- Conduct Site Initiation Visits (SIVs) and provide study-specific training to investigators and site personnel.
- Conduct clinical trial monitoring activities to ensure study quality, compliance, and protocol adherence.
- Partner cross-functionally with Clinical Operations, Clinical Affairs, Regulatory, and Quality teams to support study execution.
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