Clinical Research Coordinator I

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.

How This Role Makes a Difference

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

• Prescreen study candidates
• Obtain informed consent per Care Access Research SOP
• Follow SOPs/GCP precisely; complete documentation accurately
• Demonstrate empathy; follow patient privacy and safety protocols
• Complete visit procedures in accordance with protocol
• Complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc.
• Receive structured mentorship; participate in shadowing and skills validation
• 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
• Prioritize activities with specific regard to protocol timelines
• Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials
• 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)

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

Patient Recruitment

• 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 participants

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
• Attend Investigator meetings as required
• Adapt to new systems; seek feedback; escalate issues
• Own assigned tasks; meet deadlines with support
• Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords)
• Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management
• Maintain effective relationships with study participants and other Care Access Research personnel

The Expertise Required

• Ability to understand and follow institutional SOPs
• Excellent working knowledge of medical and research terminology
• Excellent working knowledge of federal regulations and Good Clinical Practices (GCP)
• Executes tasks with supervision; requires frequent review and guidance for visits, consent support, and complex procedures
• 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 level of self-motivation and energy
• Excellent professional writing and communication skills
• Communicates clearly with guidance; asks questions; responds timely
• Ability to work independently in a fast-paced environment with minimal supervision

Certifications/Licenses, Education, and Experience

• Minimum Education: Bachelor’s Degree preferred, or equivalent combination of education, training, and experience
• Minimum Experience: A minimum of 1-year prior Clinical Research Coordinator experience required
• Recent phlebotomy experience required

How We Work Together

Location: Position requires onsite work 5 days per week

Travel: This role requires up to 10% travel within 100 miles of site. Length of travel will depend upon study requirements, staff needs, and company initiatives.

Physical demands associated with this position include: Walking, Standing, Sitting, Lifting (Up to and Overhead 25 lbs), and Driving – 20% each

Pay

The expected pay range for this role is $55,000 – $85,000 USD per year for full-time team members.

Benefits & Perks (US Full-Time Employees)

• Paid Time Off (PTO) and Company Paid Holidays
• 100% Employer paid medical, dental, and vision insurance plan options
• Health Savings Account and Flexible Spending Accounts
• Bi-weekly HSA employer contribution
• Company paid Short-Term Disability and Long-Term Disability
• 401(k) Retirement Plan, with Company Match