Clinical Research Coordinator

Overview

Full Cycle Clinical Research Coordinator – Alzheimer’s Trials – Ocala, FL. We are seeking a highly motivated and detail-oriented Clinical Research Coordinator to oversee and manage all aspects of Alzheimer’s disease clinical trials from study start-up through close-out. The ideal candidate will have strong knowledge of GCP, FDA regulations, and experience in neurodegenerative research, particularly in Alzheimer’s disease. This role requires excellent organizational, communication, and interpersonal skills to coordinate with internal teams, study participants, sponsors, and regulatory bodies.

• Collaborate with sponsors, regulatory affairs, and site leadership to initiate Alzheimer’s trials
• Prepare, submit, and track IRB submissions, amendments, and regulatory documents
• Coordinate feasibility assessments, site selection activities, and pre-study visits
• Develop and implement recruitment strategies targeting Alzheimer’s patients and caregivers
• Screen, consent, and enroll participants according to protocol and ethical guidelines
• Maintain patient confidentiality and advocate for participant welfare
• Schedule and conduct study visits per protocol requirements
• Collect, document, and enter clinical data accurately into EDC systems
• Administer cognitive assessments (e.g., MMSE, MoCA) and track clinical outcomes
• Monitor for adverse events and report accordingly
• Dispense and manage investigational products and ensure compliance
• Ensure adherence to study protocols, GCP, FDA, ICH, and institutional policies
• Maintain complete and accurate study documentation (regulatory binders, source documents, logs)
• Prepare for and participate in sponsor monitoring visits, audits, and inspections
• Assist with study close-out activities, final data entry, and archiving of essential documents
• Contribute to final study reports and publications as needed

Required:

• Bachelor’s degree in life sciences, healthcare, or related field
• 2+ years of experience coordinating clinical trials (CNS or Alzheimer’s research preferred)
• Knowledge of ICH-GCP, FDA regulations, and clinical trial processes
• Strong organizational, communication, and interpersonal skills
• CPR/First Aid certified (or willingness to obtain)

Preferred:

• CCRC or ACRP certification
• Experience administering neuropsychological assessments
• Familiarity with Alzheimer’s disease clinical trial protocols (e.g., ADNI, DIAN, AHEAD)

Work is performed in a clinical and/or research setting. Ability to sit or stand for extended periods and lift up to 25 lbs.