Clinical Research Associate

Clinical Research Associate

The Clinical Research Associate (CRA) is responsible for the management and monitoring of assigned clinical research studies and investigative sites. This role ensures studies are conducted in compliance with Good Clinical Practice (GCP), applicable regulatory requirements, company policies, and established quality standards.

The CRA will collaborate closely with cross-functional teams and study sites to support the successful execution of clinical research activities. This position offers an excellent opportunity for early-career clinical research professionals to develop monitoring expertise through hands-on site management, study oversight, and collaboration with experienced clinical operations leaders. This role requires approximately 40% travel.

The CRA will have strong organizational, communication, and site management skills and the ability to manage multiple priorities and meet competing deadlines in a fast-paced environment. They will work independently while fostering teamwork in a remote or hybrid environment.

Responsibilities

• Manage and monitor assigned clinical sites and studies to ensure compliance, quality, and operational success.
• Conduct monitoring activities, including qualification, initiation, routine monitoring, and closeout visits through onsite, remote, virtual, or in-house methods.
• Perform source data review (SDR) and source data verification (SDV) according to study requirements.
• Develop a comprehensive understanding of study protocols, investigational products, instructions for use (IFU), and related study documentation.
• Review and contribute to monitoring plans, study source documents, and other study-related materials.
• Ensure sites conduct clinical studies in compliance with protocol requirements, GCP, ISO standards, regulatory requirements, and IRB/EC policies.
• Prioritize patient safety and verify proper informed consent procedures are followed and documented.
• Support site feasibility assessments and site selection activities.
• Prepare timely, accurate, and high-quality monitoring reports, visit documentation, and communication records.
• Facilitate site initiation visits and support the development and delivery of site-facing training and presentation materials.
• Identify, communicate, and help resolve study risks, issues, and compliance concerns.
• Participate in study team meetings and provide regular updates regarding site status, performance, risks, and progress.
• Maintain Trial Master Files (TMF) and ensure timely site closeout activities.

Required Qualifications

• Bachelor's degree or higher in healthcare, life sciences, or related scientific discipline.
• Working knowledge of clinical trial processes, monitoring activities, data management, and investigational product handling.
• Knowledge of applicable regulations and guidelines, including ICH-GCP, FDA regulations, ISO standards, and HIPAA requirements.

Preferred Qualifications & Skills

• 2 years of Clinical Research Associate experience, Clinical Research Coordinator experience, or relevant laboratory experience supporting clinical research, diagnostics, biotechnology, medical device, or pharmaceutical studies.
• Experience supporting diagnostic, in vitro diagnostic (IVD), point-of-care (POC), molecular biology, microbiology, or laboratory-based clinical studies.
• Laboratory experience in molecular biology, microbiology, or blood culture testing.
• Experience working with electronic data capture (EDC), clinical trial management systems (CTMS), and electronic Trial Master File (eTMF) platforms.
• Experience with Veeva Vault TMF and/or Veeva CDMS platforms.

What Makes You Successful

• Strong attention to detail and commitment to quality.
• Ability to build relationships with investigative sites and internal stakeholders.
• Excellent organizational and time-management skills.
• Strong written and verbal communication skills.
• Adaptability and willingness to learn in a fast-paced clinical research environment.