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.

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
  • Coverage of 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
  • Adapts to new systems; seeks feedback; escalates issues
  • Owns 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)
  • Maintains effective relationships with study participants and other Care Access Research personnel

Requirements

• 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)
• 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 and capabilities 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

Qualifications

• Bachelor’s Degree preferred, or equivalent combination of education, training, and experience
• A minimum of 1-year prior Clinical Research Coordinator experience required
• Recent phlebotomy experience required
• Licenses:
• Required: National phlebotomy certification by an organization approved by the Louisiana State Board of Medical Examiners

Pay

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

Schedule

Position requires onsite work 5 days per week

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

Diversity & Inclusion

We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission.

Mandatory Employer Disclosures

• Notice to Illinois applicants: Applicants are not obligated to disclose expunged juvenile records or adjudication, arrest, or conviction.
• Notice to Connecticut applicants: Care Access may require applicants to submit to a urinalysis drug test in connection with an application for employment.
• Notice to Arizona, Georgia, Indiana, and North Dakota applicants: Care Access complies with applicable laws prohibiting smoking in and around places of employment.
• Notice to Massachusetts applicants: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
• Notice to Rhode Island applicants: Care Access complies with Rhode Island law prohibiting smoking in enclosed areas within places of employment. Care Access is also subject to is subject to Chapters 29–38 of Title 28 of the Rhode Island General Laws.
• Notice to Maryland applicants: UNDER MARYLAND LAW, AN EMPLOYER MAY NOT REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE 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.

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