(Senior) Clinical Research Associate

Company Description Laplace Interventional is a medical device company focused on developing a minimally invasive transcatheter treatment for patients with Tricuspid Regurgitation. The team is dedicated to advancing cardiovascular care through innovative technologies that improve patient outcomes and quality of life. Laplace Interventional offers a collaborative environment where technical expertise and hands-on craftsmanship directly support product development and clinical impact. Team members have the opportunity to contribute to cutting-edge solutions in structural heart interventions while working closely with engineering and clinical partners. The company recently got IDE approval for its pivotal trial and is backed by both strategic as well as venture investors. 

Position Title: Senior Clinical Research Associate

Reporting To: Senior Director of Clinical Affairs

POSITION SUMMARY

We are seeking a Senior Clinical Research Associate to support clinical studies of an investigational structural heart implant, including early feasibility and pivotal trial execution. This individual will manage assigned sites, conduct or oversee monitoring activities, and coordinate with contract research organizations (CROs) to protect participant safety, maintain reliable data, and keep studies progressing.

This is a hands-on individual contributor role requiring independent judgment, strong relationships with investigators and study coordinators, and timely escalation of risks. The scope includes overseeing the day-to-day management of assigned sites from qualification and start-up through enrollment, follow-up, and closeout in compliance with Good Clinical Practice and applicable regulatory requirements, and the experience necessary to support the development and revision of study tools, manuals, and training materials.

RESPONSIBILITIES

·      Lead day-to-day management of assigned sites from qualification and start-up through enrollment, follow-up, and closeout; identify barriers and track actions to resolution.

·      Coordinate collection and review of essential documents, ethics approvals, agreements, and training records; verify site readiness and recommend activation to the authorized study lead.

·      Conduct assigned qualification, initiation, monitoring, and closeout visits remotely or on site. Document findings promptly and follow through on corrective actions.

·      Review informed consent, eligibility documentation, protocol compliance, source records, study data, and investigational device accountability as required by the monitoring plan.

·      Partner with CRO monitors and study teams to review monitoring reports, track overdue activities, and escalate recurring findings or site performance concerns.

·      Support timely identification, documentation, and follow-up of adverse events, device deficiencies, and protocol deviations; escalate safety concerns through established study processes.

·      Work with sites and data management to resolve queries, obtain missing follow-up data, and prepare for data reviews and database lock while preserving investigator responsibility for data and medical decisions.

·      Maintain complete, accurate study records in the trial master file and relevant tracking systems; support document quality checks, reconciliation, and audit readiness.

·      Train site personnel and support development and revision of study tools, manuals, and training materials. Document training and reinforce consistent study procedures.

·      Track enrollment, follow-up, monitoring, and outstanding issues; provide clear status updates and practical recommendations to Clinical Affairs leadership.

·      Support audits and inspections, root cause investigations, and corrective and preventive actions in collaboration with Quality and study leadership.

·      Collaborate with clinical specialists, Regulatory Affairs, Quality, and vendors; mentor less experienced clinical staff and contribute to practical process improvements.

REQUIRED EXPERIENCE

·      Bachelor’s degree in a life science, nursing, health-related discipline, or equivalent relevant experience.

·      At least five years of clinical research experience, including at least two years of independent clinical monitoring experience.

·      Experience with interventional medical device studies and management of sites across multiple stages of a clinical trial.

·      Working knowledge of Good Clinical Practice, applicable FDA investigational device requirements, ISO 14155, and IRB requirements.

·      Ability to interpret protocols and medical records, identify discrepancies and compliance risks, and drive issues to documented resolution.

·      Experience using electronic data capture, clinical trial management, and electronic trial master file systems; proficiency with Microsoft Office.

·      Strong written communication, organization, and relationship management skills; ability to prioritize independently in a changing environment.

·      Ability to meet the travel requirements (est. 20%) and work effectively with geographically distributed sites and colleagues.

PREFERRED EXPERIENCE (Not Required)

·      Experience with structural heart, interventional cardiology, or other Class III implant studies, particularly U.S. IDE and randomized pivotal trials.

·      Sponsor-side experience, including CRO oversight, in a medical device startup or small clinical team.

·      Experience supporting safety event documentation, endpoint adjudication materials, imaging core laboratories, and long-term patient follow-up.

·      Experience with international sites, audit or inspection preparation, or a relevant professional certification such as ACRP or SOCRA.

POSITION DETAILS

This is a full-time position located in Plymouth, MN. Hybrid or Remote options can be considered.