Sr. Clinical Research Associate (Cardiac Catheter Products)

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Sr. Clinical Research Associate (Cardiac Catheter Products) based in the United States.

This is an exciting opportunity to support the successful execution of clinical studies for innovative cardiac catheter products in a fast-growing medical technology environment. The role will oversee and monitor clinical research activities across U.S. and international sites, helping ensure studies are conducted with scientific rigor and regulatory compliance. You will work closely with clinical sites and cross-functional teams to protect study participants while maintaining high-quality clinical data. The position combines hands-on site management, regulatory oversight, data review, and clinical project coordination across multiple studies. You will also contribute to study documentation, monitoring strategy, submissions, and trial metrics while helping resolve issues and maintain timelines. As a senior member of the clinical research team, you will provide guidance and mentorship to other Clinical Research Associates. This role is ideal for an experienced clinical research professional who enjoys working independently in an innovative, collaborative, and rapidly evolving environment.

Accountabilities

• Manage and monitor clinical research activities across U.S. and international clinical sites, supporting multiple studies with limited supervision.
• Provide clinical case support to research sites and coordinate site activities throughout the study lifecycle.
• Monitor patient recruitment, study participation, clinical data, and site performance to ensure studies remain on track.
• Review paper and electronic case report forms, source documentation, and other study records to confirm protocol adherence, data quality, and scientific validity.
• Prepare and maintain study and project documentation, including informed consent forms, CRFs, study guides, reference binders, patient diaries, monitoring tools, and related materials.
• Produce high-quality monitoring reports, confirmation letters, and follow-up communications in accordance with SOPs and monitoring plans.
• Track and ensure timely closure of missing action items, data queries, protocol deviations, and other study-related issues.
• Review and approve essential regulatory documentation across multiple clinical studies.
• Support clinical submissions to IRBs/IECs and applicable regulatory authorities.
• Assist with the development and monitoring of study metrics to promote efficient clinical trial execution.
• Monitor clinical data and ensure queries are addressed and closed within established study timelines.
• Maintain strong knowledge of study protocols and product development activities across assigned programs.
• Ensure clinical studies comply with applicable FDA requirements, ICH-GCP principles, SOPs, protocols, and relevant local regulations.
• Protect the rights, safety, and well-being of study participants and verify that appropriate informed consent is obtained before participation.
• Manage investigational product accountability, including storage, inventory, dispensing and receipt records, returns, and destruction.
• Ensure adverse events and serious adverse events are reported appropriately in accordance with protocols and applicable regulations.
• Manage documentation, tracking, and escalation of protocol deviations.
• Participate in site audits and other quality activities as requested.
• Partner effectively with clinical and cross-functional teams, escalating risks and issues appropriately.
• Coach and mentor other Clinical Research Associates and contribute to their professional development and training.

Requirements

• Bachelor’s degree or equivalent combination of education and relevant experience.
• At least 5 years of experience directly supporting clinical research or working in a relevant medical or scientific field.
• At least 3 years of Clinical Research Associate experience supporting medical device or biotechnology clinical trials.
• Cardiovascular device or cardiac clinical research experience is strongly preferred.
• CRA certification, such as CCRA, CCRP, or another recognized certification, is strongly preferred.
• Strong knowledge of clinical research processes, ICH-GCP, FDA regulations, SOPs, and applicable local clinical research requirements.
• Familiarity with U.S. and European regulatory requirements and ethics committee procedures, as applicable.
• Knowledge of clinical strategy, regulatory submissions, product launch activities, labeling, advertising and promotion, product vigilance, and medical device reporting.
• Proficiency with EDC and CTMS platforms and the ability to quickly learn additional clinical research technologies.
• Strong proficiency with Adobe Acrobat, Microsoft Word, Excel, PowerPoint, and Smartsheet.
• Excellent written, verbal, presentation, and interpersonal communication skills.
• Strong critical-thinking, analytical, problem-solving, and decision-making abilities.
• Highly organized and detail-oriented, with the ability to independently manage short- and long-term projects and recommend appropriate actions.
• Demonstrated ability to coordinate multiple priorities, work effectively within a team, and adapt to changing business and study requirements.
• Strong judgment and initiative, with the ability to recognize when issues require escalation to clinical or management leadership.
• Comfortable working in a dynamic, fast-paced environment where priorities may evolve rapidly.
• Willingness to travel approximately 30%-50% of the time, including overnight and potentially international travel.
• Ability to lift approximately 10-15 pounds.

Benefits

• Remote work opportunity within the United States.
• Comprehensive health insurance options and supplemental insurance plans.
• 401(k) retirement savings plan.
• Stock option awards and Employee Stock Purchase Plan (ESPP), providing opportunities to share in organizational growth.
• Paid time off and paid holidays.
• Flexible work schedule designed to support work-life balance.
• Wellness program with resources such as an onsite gym and mindfulness classes.
• Professional and personal development opportunities within a growing, innovation-focused environment.
• Opportunity to contribute to the development of innovative medical technologies with potential impact on patient care.
• Collaborative culture focused on scientific rigor, creativity, professional growth, and meaningful healthcare outcomes.
• Equal employment opportunities and reasonable accommodations for qualified individuals with disabilities.