Sr. Clinical Research Associate

Key Responsibilities

• Conduct and oversee all types of site visits (e.g., selection, initiation, interim, close-out) to ensure protocol adherence, patient safety, and data accuracy.
• Collaborate with Principal Investigators, study coordinators, and cross-functional teams to drive study success.
• Ensure compliance with ICH/GCP, IRB requirements, and internal monitoring plans.
• Identify and resolve data collection issues within electronic data capture (EDC) systems.
• Review and reconcile data queries, listings, and discrepancies.
• Maintain accurate and complete study documentation and files.
• Lead study team meetings and contribute to protocol development and amendments.
• Support site recruitment and provide oversight to ensure enrollment goals are met.
• Mentor junior CRAs and provide technical expertise in clinical programming and data validation.
• Assist in the development and refinement of SOPs, workflows, and templates.
• Partner with Clinical Trials Manager to manage timelines, budgets, and resources.
• Liaise with regulatory authorities and CROs as needed.
• Ensure timely and compliant execution of monitoring reports, trip reports, and follow-up letters.
• Monitor site performance metrics and facilitate effective communication across stakeholders.

Qualifications

• Education: Bachelor’s degree or higher in biomedical sciences or a related field.
• Experience: 5+ years of experience in clinical research within biotech, pharma, medical device, or academia.
• Strong knowledge of GCP, FDA regulations, and ISO standards.
• Proficiency in EDC systems, CTMS, and Microsoft Office Suite.
• Certification (CCRC or CCRA) is a plus.
• Excellent understanding of medical terminology and clinical trial processes.
• Proven ability to manage multiple studies and priorities with precision and urgency.
• Exceptional communication, organizational, and interpersonal skills.
• Demonstrated ability to work independently and collaboratively in remote, cross-functional teams.
• Ability to travel up to 75% of the time.

Additional Details

We are a leading precision medicine solutions company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. Our products, testing services, and digital healthcare solutions cover the pre- and post-transplant patient journey, and we are the leading provider of genomics-based information for transplant patients.

Our competitive Total Rewards package includes:

• Competitive base salary and incentive compensation
• Health and welfare benefits, including a gym reimbursement program
• 401(k) savings plan match
• Employee Stock Purchase Plan
• Pre-tax commuter benefits

We also offer:

• A Living Donor Employee Recovery Policy that allows up to 30 days of paid leave annually to a full-time employee who makes the selfless act of donating an organ or bone marrow.

Join us in transforming the future of organ transplant care. Apply now!