Senior Clinical Research Coordinator - Axiom Brain Health, Tampa, FL

JOB SUMMARY

The Senior Clinical Research Coordinator at Axiom Brain Health is responsible for independently coordinating, implementing and managing a diverse clinical trial portfolio in accordance with Good Clinical Practice (GCP), Institutional Review Board (IRB) approvals, and regulatory requirements. This role serves as a subject-matter resource for junior staff, supports protocol compliance oversight, liaises with sponsors and monitors, and helps foster a culture of quality, collaboration, continuous learning, and participant safety.

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

This position offers the opportunity to work with innovative therapies, advanced diagnostics, and industry-leading sponsors while making a meaningful difference in the lives of patients affected by neurological disease.

KEY RESPONSIBILITIES

Study Coordination

• Independently coordinates multiple clinical research studies across varying therapeutic areas and phases while maintaining exceptional quality and regulatory compliance.
• Reviews study protocols and identify operational needs, feasibility, and required resources.
• Schedules and conducts all aspects of participant study visits, study procedures, laboratory collection and handling, third-party facility and procedure management, collects research data and other protocol assessments.
• Collaboration with Investigators and Site Director to identify and resolve study related challenges while maintaining protocol integrity.
• Build strong relationships with sponsors, CROs, and monitors to support successful study conduct and site performance.

Participant Management

• Conducts informed consent discussions while ensuring participants, care givers, and study partners fully understand study requirements and their rights during participation.
• Ensure all participants receive exceptional participant experience through

compassionate care, education, and consistent care and communication.

• Ensures documentation aligns with ALCOA-C practices.
• Monitor participant safety, identify and document adverse events, and communicate with Principal Investigator (PI) and sponsor, as required.
• Supports participant retention through timely follow-up, visit reminders, and engagement.

Regulatory & Documentation

• Ensure compliance with protocol, FDA regulations, ICH-GCP guidelines, IRB regulations, institutional policies, HIPAA regulations and Good Documentation Practices (GDP).
• Knowledgeable in how to prepare, submit, and maintain regulatory documents, IRB submissions, continuing reviews, and investigator site files (ISF).
• Maintain accurate, complete, timely, and audit-ready source documentation, case report forms (CRFs), and study records.
• Ensures investigational product (IP) accountability and compliance in collaboration with pharmacy or designated site personnel.
• Participate in Site Selection Visits (SSV), Site Initiation Visits (SIV), Investigator Meetings (IM), sponsor monitoring visit (IMV), audits, inspections and internal quality initiatives.
• Identify protocol deviations, report and collaborate with the Site Director on the assessment of root cause, and contribute to corrective and preventative action (CAPA) activities as applicable.

Data Management

• Performs data entry and query resolution in electronic data capture (EDC) systems within the contracted timeline.
• Resolve data queries and monitor findings promptly while ensuring data accuracy and completeness.
• Monitor study to identify potential opportunities for improvement in study performance and participant retention and outcomes.

Leadership & Collaboration

• Serves as a resource and mentor to junior level staff members including but not limited to Clinical Research Coordinators, Research Assistants and other research personnel.
• Assists with onboarding and training new team members on site operating procedures (SOP), study specific protocol procedures, documentation standards, and compliance and regulatory requirements.
• Promote a culture of collaboration, accountability, continuous improvement, high-quality and operational excellence.
• Contribute to continuous improvement of workflow efficiency, participant experience, and overall site performance.
• Collaborates effectively with investigators, clinical teams, sponsors, CROs, and regulatory personnel.

Qualifications

Knowledge, Skills, Abilities

• Medical terminology
• Comprehensive understanding of clinical research regulations and study conduct.
• Ability to effectively communicate (both verbal and written) with participants, caregivers, study partners, colleagues, sponsors, CROs, and external vendors.
• Strong organizational skills with the ability to multitask, strong attention to detail, and problem solving with the highest level of quality.
• Ability to work in a fast-paced environment
• Ability to be a strong mentor to junior level colleagues
• Ability to work collaboratively and cooperatively with others
• Acceptance of direction and constructive criticism
• Experience working with CTMS systems (eRegulatory and eSource); ability to learn databases (e.g., RealTime CTMS)
• Familiar with Google Suite, Microsoft Word, Excel, and Power Point and Outlook.
• Passionate about advancing neurological research and improving the lives of patients through innovation.

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.

Why join Axiom Brain Health?

At Axiom Brain Health, you'll have the opportunity to:

• Make a meaningful impact on the future of Alzheimer's disease, Parkinson's disease, Multiple Sclerosis, and other neurological disorders.
• Work alongside experienced physicians, clinical research professionals, and spectacular research partners.
• Coordinate innovative clinical trials involving cutting-edge therapies and diagnostics.
• Mentor and develop the next generation of clinical research professionals.
• Expand your expertise through ongoing professional development and exposure to

complex clinical trials.

• Be part of a collaborative, mission-driven culture that values quality, integrity, innovation, compassion, and continuous learning.
• Grow your career with opportunities for advancement into leadership positions as our research programs continue to expand.

What Success Looks Like

Within your first year, you will:

• Successfully manage multiple active clinical trials with exceptional quality and compliance.
• Build collaborative relationships with participants, caregivers, study partners, sponsors, CROs, monitors, and colleagues.
• Serve as a mentor and resource for junior research staff.
• Contribute to strong enrollment, participant retention, and study performance metrics.
• Help strengthen Axiom Brain Health's reputation as a premier destination for neurological clinical research.

Required:

• Bachelor’s degree in health-related, life science, or scientific field; or equivalent clinical research experience.
• Minimum 3–5 years of clinical research coordination experience.
• Demonstrate the ability to independently manage multiple clinical research studies while maintaining high-quality and regulatory standards.
• Strong knowledge of FDA regulations, ICH-GCP, Good Documentation Practices (GDP)/ALCOA-C, and clinical research compliance.
• Experience conducting informed consent, coordinating study visits, collecting research data, and managing CRFs/EDC systems independently.
• Strong interpersonal skills with the ability to build relationships with participants, caregivers, study partners, colleagues, external vendors, sponsors and CROs, while demonstrating and maintaining excellent organizational, communication and critical thinking skills.

Preferred:

• ACRP, SoCRA, or equivalent clinical research certification (CCRC, CCRP, ACRP-CP).Bilingual English/Spanish.
• Experience in neurology, Alzheimer’s disease, Parkinson’s disease, Multiple Sclerosis(MS), or other multiple therapeutic areas or complex interventional trials.
• Familiarity with FDA inspections or sponsor audits.
• Experience working with CTMS platforms such as RealTime CTMS, eRegulatory and eSource.

Compensation

Salary Range: $65,000-85,000

Benefits may include health insurance, retirement savings, paid time off, performance incentives, and professional development opportunities.