Clinical Research Coordinator II

About Care Access

Care Access is working to make the future of health better for all. With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. 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.

• Patient Coordination
  • 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 Care Access Research personnel
  • Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management
  • Coordinate and attend pre‑study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives
  • Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor where appropriate
  • 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
  • Review laboratory and imaging results for completeness and alert values, ensuring investigator review in a timely fashion
  • Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff
• Documentation
  • Record data legibly and enter in real time on paper or e‑source documents
  • Accurately record study medication inventory, 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
  • Assist in the creation and review of source documents
• Patient Recruitment
  • Assist with planning and creation of appropriate recruitment materials
  • Develop recruitment plan and obtain listings of potential candidates from subject database
  • Actively work with recruitment team in calling and recruiting subjects
• Review and assess protocol (including amendments) for clarity and logistical feasibility
• Ensure that all training and study requirements are met prior to trial conduct
• Communicate clearly verbally and in writing
• Attend investigator meetings as required
• Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords)

• Ability to understand and follow institutional SOPs
• Excellent working knowledge of medical and research terminology
• Knowledge of federal regulations and GCP
• Ability to communicate and work effectively with a diverse team
• Strong organizational, prioritization and leadership skills with strong attention to detail
• Strong computer skills with use of 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 level of self‑motivation and energy
• Excellent professional writing and communication skills
• Ability to work independently in a fast‑paced environment with minimal supervision

• Bachelor’s Degree preferred or equivalent combination of education, training and experience
• Minimum of 3 years prior Clinical Research Coordinator experience required
• Prefer 1 year of experience as a Care Access Research…