Clinical Research Coordinator I

About the role

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.

Responsibilities

• Patient Coordination
  • Prescreen study candidates
  • Obtain informed consent per Care Access Research SOP
  • Follows SOPs/GCP precisely; completes documentation accurately
  • Demonstrates empathy; follows patient privacy and safety protocols
  • Complete visit procedures in accordance with protocol
  • Complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc.
  • Receives structured mentorship; participates 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
  • Low complexity; stable protocols with limited procedures and minimal IP handling
  • 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
• Carefully 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)
• Document 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
  • Aid in developing 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
  • Adapts to new systems; seeks feedback; escalates issues
  • Owes assigned tasks; meets deadlines with support
  • Ensures adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords)
  • Interacts in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management
  • Maintains effective relationships with study participants and other Care Access Research personnel

Qualifications

• 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

Benefits & Perks

• 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 Mandatory

Physical Demands

• Walking
• Sitting
• Lifting (Up to and Overhead 25 lbs)
• Driving - 20%

Pay Range

$55,000 - $85,000 USD per year for full time team members

Equal Opportunity Employer

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.

Notice to Applicants

• Under Maryland law, an employer may not require or demand, as a condition of employment or continued employment, that an individual submit to or take a lie detector or similar test. An employer who violates this law is guilty of a misdemeanor and subject to a fine not exceeding $100.