Senior Clinical Research Coordinator

***Must be located/based in Tampa, Florida*****

Location: On site, Tampa, FL

JOB SUMMARY

The Senior Clinical Research Coordinator at Axiom Brain Health is responsible for the coordination, implementation, and management of clinical research studies 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 ensures high-quality data collection 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.

KEY RESPONSIBILITIES

·      Independently coordinates multiple clinical research studies across varying therapeutic areas and phases.

·      Reviews study protocols and identifies operational needs, feasibility, and required resources.

·      Schedules and conducts participant study visits, collects research data, and manages required study procedures per protocol.

·      Ensures compliance with protocol, IRB regulations, institutional policies, FDA regulations, and ICH-GCP guidelines.

·      Conducts informed consent discussions and ensures documentation aligns with ALCOA-C practices.

·      Monitors participant safety, documents adverse events, and communicates with Principal Investigator (PI) and sponsor, as required.

·      Supports participant retention through timely follow-up, visit reminders, and engagement.

·      Knowledgeable in how to prepare, submit, and maintain regulatory documents, IRB submissions, and continuing reviews.

·      Maintains accurate and timely source documentation, case report forms (CRFs), and study files.

·      Ensures investigational product (IP) accountability and compliance in collaboration with pharmacy or designated site staff managing the IP.

·      Performs data entry and query resolution in electronic data capture (EDC) systems within the contracted timeline.

·      Participates in investigator meetings (IM), site selection visits (SSV), site initiation visits (SIV), sponsor monitoring visits, audits, inspections and quality review processes.

·      Identifies deviations and contributes to corrective and preventive action planning.

·      Serves as a resource and mentor to junior level staff members including but not limited to Clinical Research Coordinators and Research Assistants.

·      Assists in training new staff on site operating procedures (SOP), study specific protocol procedures, documentation standards, and compliance expectations.

·      Collaborates effectively with investigators, clinical teams, sponsors, CROs, and regulatory personnel.

Knowledge, Skills, Abilities

•     Medical terminology

•     Effective communication (both verbal and written)

•     Strong organizational skills with the ability to multitask

•     Ability to work in a fast-paced environment

•     Detail oriented

•     Ability to work collaboratively and cooperatively with others

•     Acceptance of direction and constructive criticism

•     Experience working with CTMS systems; ability to learn databases (e.g., RealTime CTMS)

•     Familiar using Google Suite, Microsoft Word, Excel, and Power Point, and Outlook

Required:

·      Bachelor’s degree in a health-related or scientific field; or equivalent clinical research experience.

·      Minimum 3–5 years of clinical research coordination experience.

·      Strong knowledge of ICH-GCP, Good Documentation Practices (GDP)/ALCOA-C, and clinical research regulatory requirements.

·      Experience conducting informed consent, coordinating study visits, and managing CRFs/EDC systems independently.

Preferred:

·      Certification in Clinical Research (e.g., CCRC, CCRP, ACRP-CP).

·      Spanish Speaker.

·      Experience with multiple therapeutic areas or complex interventional trials.

·      Familiarity with FDA inspections or sponsor audits.

• 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.