Clinical Research Associate

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

📋 Description

• Oversee and evaluate designated clinical sites and studies to ensure adherence to compliance, quality, and operational excellence.

• Conduct qualification, initiation, routine monitoring, and closeout visits using onsite, remote, virtual, or in-house approaches.

• Execute source data review (SDR) and source data verification (SDV).

• Gain a comprehensive understanding of study protocols, investigational products, usage instructions, and study documentation.

• Review and contribute to monitoring plans, source documents, and study-related materials.

• Ensure adherence to protocol requirements, GCP, ISO standards, regulatory guidelines, and IRB/EC policies.

• Prioritize patient safety and confirm informed consent procedures.

• Assist in site feasibility evaluations and site selection processes.

• Draft monitoring reports, visit documentation, and communication records.

• Facilitate site initiation visits and aid in the development of site-facing training and presentation materials.

• Identify, communicate, and help mitigate study risks, issues, and compliance matters.

• Participate in study team meetings and provide updates regarding site status, performance, risks, and progress.

• Maintain Trial Master Files and ensure the timely completion of site closeout activities.

• Collaborate with cross-functional teams and study sites in a remote or hybrid setting.

⛳️ Requirements

• A Bachelor's degree or higher in healthcare, life sciences, or a related scientific field.

• Proficient knowledge of clinical trial processes, monitoring activities, data management, and investigational product handling.

• Familiarity with ICH-GCP, FDA regulations, ISO standards, and HIPAA requirements.

• A minimum of 2 years of experience as a Clinical Research Associate, Clinical Research Coordinator, or similar laboratory role supporting clinical research, diagnostics, biotechnology, medical devices, or pharmaceutical studies.

• Experience in 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.

• Proficiency 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.

• Strong attention to detail and a commitment to quality.

• Ability to establish relationships with investigative sites and internal stakeholders.

• Exceptional organizational and time-management skills.

• Strong written and verbal communication abilities.

• Adaptability and willingness to learn in a dynamic clinical research environment.

• Willingness to travel approximately 40% of the time.

🏝️ Benefits

• Comprehensive Total Rewards program.

• Opportunities for rewards and recognition.

• Competitive compensation and benefits packages.

• Opportunities for personal and professional growth.

• In-person collaboration that fosters learning, progress, and success.