Sr. Clinical Research Associate

CareDx, Inc.; Oregon; Ibrido; USD 100.000 - 130.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health and welfare benefits

401(k) match

Employee Stock Purchase Plan

Gym reimbursement program

Pre-tax commuter benefits

Living Donor Employee Recovery Policy

Descrizione del lavoro

CareDx, Inc. is seeking a Senior Clinical Research Associate to join our Clinical Operations team. The role focuses on ensuring integrity, quality, and compliance of clinical trials in a fast-paced environment.

You will lead site visits, collaborate with investigators and cross-functional teams, and mentor junior CRAs. The ideal candidate has 5+ years in clinical research, strong GCP/FDA knowledge, and experience with EDC/CTMS.

Competenze

• Bachelor's degree or higher in biomedical sciences or related field.
• 5+ years of experience in clinical research.
• Strong knowledge of GCP, FDA regulations, and ISO standards.
• Certification (CCRC or CCRA) is a plus.

Mansioni

• Conduct and oversee site visits to ensure protocol adherence and data accuracy.
• Collaborate with investigators, coordinators, and cross-functional teams to drive study success.
• Ensure compliance with ICH/GCP, IRB requirements, and monitoring plans.
• Identify and resolve data collection issues within EDC systems.
• Review and reconcile data queries, listings, and discrepancies.
• Maintain complete study documentation and files.
• Lead study team meetings and contribute to protocol development.
• Support site recruitment and oversight to meet enrollment goals.
• Mentor junior CRAs and provide expertise in clinical programming and data validation.
• Assist in SOPs, workflows, and templates development.
• Partner with Clinical Trials Manager to manage timelines, budgets, and resources.
• Liaise with regulatory authorities and CROs as needed.
• Ensure timely monitoring reports and follow-ups.
• Monitor site performance metrics and facilitate stakeholder communication.

Conoscenze

GCP knowledge

FDA regulations

Clinical data review

Communication skills

Travel readiness

Formazione

Bachelor's degree in biomedical sciences

Strumenti

EDC systems

CTMS

MS Office

Descrizione del lavoro

CareDx, Inc. is 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. CareDx offers products, testing services, and digital healthcare solutions along the pre- and post-transplant patient journey, and is the leading provider of genomics-based information for transplant patients.We are seeking a highly skilled and motivated Senior Clinical Research Associate to join our Clinical Operations team. This role is pivotal in ensuring the integrity, quality, and compliance of our clinical trials. The ideal candidate will bring deep expertise in clinical study management, a passion for improving patient outcomes, and the ability to lead and mentor within a fast-paced, collaborative environment.

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.

What You Bring

• A proactive mindset and high standards for quality and accuracy.
• Strong analytical and problem-solving skills.
• Ability to adapt quickly to changing demands and environments.
• A customer-focused approach in working with sites and external partners.
• A commitment to continuous improvement and operational excellence.

Additional Details:Every individual at CareDx has a direct impact on our collective mission to improve the lives of organ transplant patients worldwide. We believe in taking great care of our people, so they take even greater care of our patients.

Our competitive Total Rewards package for US Employees 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
• And more!
• 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.

With products that are making a difference in the lives of transplant patients today and a promising pipeline for the future, it’s an exciting time to be part of the CareDx team. Join us in partnering with transplant patients to transform our future together.

CareDx, Inc. is an Equal Opportunity Employer and participates in the E-Verify program.

Remote: US only roles

$100,000—$130,000 USD