Clinical Research Coordinator II

About Care Access

Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly into communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow.

Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all. To learn more about Care Access, visit

The Clinical Research Coordinator’s primary responsibilities are to utilize Good Clinical Practices (GCPs) in the process of screening, enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance.

• Duties include but not limited to:
  • Ability to understand and follow institutional SOPs
  • Review and assess protocol (including amendments) for clarity, logistical feasibility
  • Ensure that all training and study requirements are met prior to trial conduct
  • Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff
  • Assist with planning and creation of appropriate recruitment materials
  • Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database
  • Actively work with recruitment team in calling and recruiting subjects
  • Attend Investigator meetings as required
  • Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives
  • Assist in the creation and review of source documents
  • Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords)
• Study Management
  • Prioritize activities with specific regard to protocol timelines
  • Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials
  • Maintain effective relationships with study participants and other Care Access Research personnel
  • Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management
  • Communicate clearly verbally and in writing
• Patient Coordination
  • Prescreen study candidates
  • Obtain informed consent per Care Access Research SOP
  • Complete visit procedures in accordance with protocol
  • Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc.
  • Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion
  • Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate)
• Documentation
  • Record data legibly and enter in real time on paper or e-source documents
  • Accurately record study medication inventory, medication dispensation, and patient compliance
  • Resolve data management queries and correct source data within sponsor provided timelines
  • Assist regulatory personnel with completion and filing of regulatory documents
  • Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

• Excellent working knowledge of medical and research terminology
• Excellent working knowledge of federal regulations, good clinical practices (GCP)
• Ability to communicate and work effectively with a diverse team of professionals
• Strong organizational, prioritization and leadership skills with a strong attention to detail
• Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS Word and Excel
• Critical thinker and problem solver
• Friendly, outgoing personality; maintain a positive attitude under pressure
• High…