Medix™
LOOKING FOR CANDIDATES TO RELOCATE TO FL. RELOCATION ASSISTANCE AVAILABLE
Job Title: Full Cycle Clinical Research Coordinator – Alzheimer’s Trials
Location: Ocala, FL
Position Summary We are seeking a highly motivated and detail-oriented Full Cycle Clinical Research Coordinator (CRC) 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.
Key Responsibilities Study Start‑Up
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
Study Coordination & Conduct
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
Regulatory & 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
Close‑Out & Reporting
Assist with study close‑out activities, final data entry, and archiving of essential documents
Contribute to final study reports and publications as needed
Qualifications 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
Proficiency in clinical systems (EDC, CTMS, eRegulatory, etc.)
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 Environment & Physical Demands
Work is performed in a clinical and/or research setting
Ability to sit or stand for extended periods and lift up to 25 lbs
Seniority level
Associate
Employment type
Full‑time
Job function
Administrative, Research, and Health Care Provider
Industries
Hospitals and Health Care and Research Services
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Job Title: Full Cycle Clinical Research Coordinator – Alzheimer’s Trials
Location: Ocala, FL
Position Summary We are seeking a highly motivated and detail-oriented Full Cycle Clinical Research Coordinator (CRC) 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.
Key Responsibilities Study Start‑Up
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
Study Coordination & Conduct
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
Regulatory & 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
Close‑Out & Reporting
Assist with study close‑out activities, final data entry, and archiving of essential documents
Contribute to final study reports and publications as needed
Qualifications 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
Proficiency in clinical systems (EDC, CTMS, eRegulatory, etc.)
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 Environment & Physical Demands
Work is performed in a clinical and/or research setting
Ability to sit or stand for extended periods and lift up to 25 lbs
Seniority level
Associate
Employment type
Full‑time
Job function
Administrative, Research, and Health Care Provider
Industries
Hospitals and Health Care and Research Services
#J-18808-Ljbffr