Clinical Research Coordinator (in-person)

JOB SUMMARY

The Clinical Research Coordinator at Axiom Brain Health is responsible supporting the coordination, implementation, and day-to-day management of clinical research studies in accordance with Good Clinical Practice (GCP), Institutional Review Board (IRB) approvals, and regulatory requirements. This role ensures protocol compliance oversight, high-quality data collection and participant safety.

This position is ideal for someone who is detail-oriented, organized, and interested in contributing to Alzheimer’s and other neurodegenerative disease research.

RESPONSIBILITIES

• Coordinates clinical research studies under the guidance of the Site Director and Principal Investigator (PI).
• Reviews study protocols and supports identification of operational needs and study requirements.
• Schedules and conducts participant study visits and performs protocol-required procedures.
• Collects and records study data in accordance with protocol and regulatory requirements.
• Ensures compliance with study protocols, IRB regulations, institutional policies, FDA regulations, and ICH-GCP guidelines.
• Maintains accurate and timely source documentation, case report forms (CRFs), and study files.
• Supports investigational product (IP) accountability in collaboration with pharmacy or designated site staff.
• Conducts informed consent discussions and ensures documentation aligns with ALCOA-C practices.
• Monitors participant safety, documents adverse events, and communicates with the PI and sponsor as needed.
• Performs data entry and resolves queries in electronic data capture (EDC) systems within required timelines.
• Participates in site visits, including site initiation visits (SIVs), monitoring visits, audits, and inspections.
• Identifies protocol deviations and communicates them to appropriate team members.
• Collaborates with investigators, clinical staff, sponsors, CROs, and regulatory personnel.
• Supports participant recruitment and retention through follow-up and engagement efforts.

Qualifications

Knowledge, Skills, Abilities

• Basic knowledge of medical terminology
• Strong verbal and written communication skills
• Strong organizational skills and attention to detail
• Ability to manage multiple tasks and prioritize effectively
• Ability to work in a fast-paced environment
• Ability to work collaboratively within a team
• Willingness to accept direction and feedback
• Experience with CTMS and/or ability to learn systems such as RealTime CTMS
• Proficiency with Google Suite, Microsoft Office (Word, Excel, PowerPoint)

Required:

• Bachelor’s degree in a health-related or scientific field; or equivalent clinical research experience
• 1–3 years of clinical research experience
• Basic understanding of ICH-GCP and clinical research processes
• Experience supporting study visits, data entry, and documentation

Preferred:

• Master’s degree in a health-related or scientific field
• Clinical research certification (e.g., CCRC, CCRP, ACRP-CP)
• Spanish-speaking
• Experience in Alzheimer’s disease or other neurodegenerative research
• Exposure to EDC systems and regulatory documentation

This role is part of a small, hands-on team, and responsibilities may evolve over time. Willingness to take on additional tasks, pitch in where needed, and support team priorities is essential.

Job Type: Full-time

Pay: $55,000.00 - $70,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Professional development assistance
• Retirement plan

Application Question(s):

• Are you authorized to work in the United States? (Required)
• Will you be able to reliably commute to Tampa, Fl 33609 for this job? (Required)

Work Location: In person