Senior Clinical Research Associate, Cardiac Catheter Products

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee and track clinical study operations at both US and international clinical locations.

• Monitor the recruitment of patients, clinical data, and all study-related information.

• Offer case support to research sites across various studies with minimal supervision.

• Prepare project and study documentation, such as informed consent forms, CRFs, study guides, reference binders, and patient diaries.

• Organize data listing reviews and interim as well as final clinical study reports.

• Examine CRFs and source documents to ensure compliance with protocols and data integrity.

• Create study-specific monitoring tools and associated documents.

• Provide monitoring reports, confirmation letters, and follow-up letters within established timelines.

• Resolve outstanding action items from monitoring visits.

• Review and authorize essential regulatory documents.

• Assist in tracking study metrics and facilitating the efficient execution of clinical trials.

• Supervise clinical data and ensure timely closure of queries.

• Support submissions to IRB/IEC and relevant regulatory authorities.

• Ensure adherence to study timelines across various studies.

• Mentor and coach other Clinical Research Associates.

• Maintain up-to-date knowledge of protocols and product development.

• Coordinate and manage site-related activities and escalate any issues as necessary.

• Safeguard the rights and well-being of study subjects and confirm informed consent.

• Manage accountability for investigational products.

• Ensure compliance with reporting of adverse events and serious adverse events.

• Handle documentation, tracking, and escalation of protocol deviations.

• Participate in site audits as requested.

⛳️ Requirements

• Bachelor’s degree (BS/BA) or equivalent professional experience.

• A minimum of 5 years of experience directly supporting clinical research or related experience in a medical/scientific field.

• At least 3 years of experience as a CRA in device or biotech clinical trials.

• Experience with cardiovascular devices is preferred.

• CRA certification, such as CCRA or CCRP, is highly desirable.

• Proficient in Adobe Acrobat, Microsoft Word, Excel, PowerPoint, Smartsheet, EDC systems, and CTMS systems.

• Familiarity with FDA and international regulations and guidelines, including GCPs, SOPs, submissions, product launches, labeling, advertising and promotion, product vigilance, and medical device reporting.

• Working knowledge of FDA, European Regulatory, and EC procedures, as applicable.

• Strong oral and written communication skills with excellent presentation abilities.

• Competencies in critical thinking, analysis, organization, problem-solving, and judgment.

• Ability to function as a team member, manage multiple tasks, and adjust to shifting priorities.

• Willingness to work flexible hours and travel 30%-50% of the time; overnight and/or international travel may be necessary.

• Capable of lifting 10-15 pounds.

🏝️ Benefits

• A range of health insurance plans along with supplemental insurance options.

• 401k retirement savings plan.

• Stock options awards.

• Employee Stock Purchase Plan (ESPP).

• Paid time off.

• Paid holidays.

• Flexible work schedule.

• Wellness program, featuring an onsite gym and mindfulness classes.

• Opportunities for professional and personal growth and development.