Clinical Research Coordinator - 247707

Medix™; Austin (TX); On-site; USD 60,000 - 80,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

A leading clinical research organization is seeking a Full Cycle Clinical Research Coordinator to manage all aspects of Alzheimer's clinical trials. This role requires knowledge of GCP and FDA regulations, excellent organizational and communication skills, and a minimum of 2 years of experience in clinical trial coordination. The candidate should hold a Bachelor’s in life sciences and have proficiency in clinical systems. Full-time position with relocation assistance available.

Qualifications

• 2+ years of experience coordinating clinical trials, preferably in CNS or Alzheimer’s research.
• Knowledge of ICH-GCP and FDA regulations.
• CPR/First Aid certified or willing to obtain.

Responsibilities

• Oversee and manage all aspects of Alzheimer’s clinical trials.
• Prepare, submit, and track IRB submissions.
• Conduct study visits and administer cognitive assessments.

Skills

Organizational skills

Communication skills

Interpersonal skills

Proficiency in EDC systems

Education

Bachelor’s degree in life sciences or related field

Tools

EDC systems

CTMS

eRegulatory systems

Job description

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