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Senior Clinical Research Associate - Cardiovascular Medical Device
T45 Labs
61d ago
0$113k - $153kOtherNew York, NY, USjobspy_indeed
remoteindeed
Job Description
**Senior Clinical Research Associate \- Cardiovascular Medical Device****Status:** Full\-time, Exempt
**Reports to:** Senior Clinical Operations Manager
**Location:** Remote
Overview
VahatiCor is an early**\-**stage cardiovascular medical device company developing break through cardiovascular technologies, including Class III catheter\-based systems. We operate with a purpose\-driven, agile, and collaborative culture, where each team member plays a meaningful role in advancing solutions that improve patient outcomes. As our clinical program grows, we are building a dedicated clinical operations team to support early feasibility studies and future pivotal trials.
The Senior Clinical Research Associate (CRA) will own site activation, clinical study startup, site management, enrollment performance, and protocol execution across VahatiCor’s cardiovascular medical device clinical trials. This role serves as the primary operational partner to clinical sites, driving site readiness, investigator engagement, enrollment success, and consistent protocol execution throughout the study lifecycle. The ideal candidate brings deep experience in sponsor\-side medical device clinical research, clinical operations, site management, and early\-stage medical device clinical trials.
Responsibilities***Site Activation \& Study Startup**** Lead site qualification, feasibility, and readiness activities for assigned **car**diovascular medical device clinical trial sites.
* Own clinical study startup and site activation activities, including collection and review of essential regulatory and startup documentation.
* Ensure investigators, study coordinators, and site personnel are prepared to enroll patients efficiently and compliantly.
* Partner with the Clinical Trials Manager and study leadership on site contracting and budgeting activities and ensure timely site activation.
* Track startup milestones and proactively identify and resolve activation barriers.
*Site Management \& Enrollment** Serve as the primary operational contact for assigned cardiovascular clinical trial sites**.**
* Build and maintain strong relationships with investigators, coordinators, and site personnel.
* Drive patient screening and enrollment activities to achieve study recruitment goals.
* Own site performance across assigned sites and implement actions to improve enrollment, protocol adherence, and study execution.
* Partner with sites to address operational challenges and maintain study momentum.
*Training \& Clinical Study Execution** Conduct Site Initiation Visits (SIVs) and provide study\-specific training to investigators and site personnel.
* Deliver ongoing site education throughout study execution.
* Ensure cardiovascular medical device clinical study activities are conducted in accordance with the protocol, Good Clinical Practice (GCP), applicable FDA medical device regulations, and company procedures.
* Participate in investigator meetings, study team meetings, and site
