Regional , Clinical Research Coordinator

regional travel, clinical research coordinator

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 to 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.

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.

the clinical research coordinator’s primary responsibilities are to utilize good clinical practices (gcp) s in the process of screening, enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance.

• 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.
• balance protocol needs with patient experience; proactively address concerns.
• interact in a positive, professional manner with patients, 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.
• mentor crc i peers; provide onboarding and day‑to‑day guidance.
• identify adverse events (aes) and serious adverse events (saes) and promptly notify principal investigator and sponsor (where appropriate)
• moderate complexity; mixed visit types, active ip and ae/sae workflows.
• obtain informed consent per care access research sop
• complete visit procedures in accordance with protocol.
• 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.
• 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, 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.
  • assist in the creation and review of source documents.
• 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
• other responsibilities
  • review and assess protocol (including amendments) for clarity, logistical feasibility
  • ensure that all training and study requirements are met prior to trial conduct.
  • communicate clearly verbally and in writing.
  • anticipate needs; propose solutions; manage change effectively.
  • attend investigator meetings as required.
  • owns studies; prioritizes competing demands; mentors crc i.
  • 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
• excellent working knowledge of federal regulations, good clinical practices (gcp)
• operates independently for most study activities; escalates complex issues as needed.
• a…