Clinical Research Coordinator

4 hours ago

Fort Myers, Florida, United States Express Employment Professionals Full time
Job Title: Clinical Research Coordinator

We are seeking a highly organized and detail-oriented Clinical Research Coordinator to join our team at Express Employment Professionals. As a Clinical Research Coordinator, you will play a critical role in the management and support of clinical research studies conducted in our laboratory.

Key Responsibilities:

  • Study Coordination: Oversee the day-to-day management of clinical studies, ensuring that all study protocols, timelines, and regulatory requirements are followed.
  • Participant Management: Recruit, screen, and schedule participants for study visits. Obtain informed consent and maintain clear communication with study participants throughout the research process.
  • Data Collection & Documentation: Ensure accurate and timely collection of study data, including laboratory samples, clinical measurements, and questionnaires. Maintain detailed and organized study records in compliance with regulatory and study-specific requirements.
  • Regulatory Compliance: Ensure all studies comply with local, state, and federal regulations, including those set by the IRB (Institutional Review Board) and FDA (Food and Drug Administration).
  • Study Protocols: Assist in developing, reviewing, and updating study protocols. Work closely with the principal investigator and research staff to ensure adherence to study objectives.
  • Monitoring & Reporting: Monitor study progress, report deviations, and ensure data integrity. Prepare and submit study reports to sponsors, regulatory authorities, and internal teams as required.
  • Coordination with Laboratory Teams: Work closely with lab technicians and research staff to ensure the correct handling, processing, and storage of biological samples.
  • Vendor & Sponsor Communication: Act as the primary point of contact for study sponsors, vendors, and CROs (Contract Research Organizations), ensuring clear communication on study timelines, data queries, and deliverables.
  • Quality Assurance: Conduct routine quality checks on study data and procedures to ensure compliance with study protocols and regulatory standards.
  • Budget Management: Assist in the management of study budgets, including tracking expenditures and managing study-related expenses.
  • Training & Supervision: Train and supervise junior research staff, lab technicians, and interns involved in the study to ensure quality and consistency in study procedures.

Requirements:

  • Education: Bachelor's degree in biology, clinical research, or a related scientific field. A master's degree or certification in clinical research (e.g., SOCRA, ACRP) is preferred.
  • Experience:
    • Minimum of 2-3 years of experience as a Study Coordinator or similar role, preferably within a clinical or laboratory setting.
    • Familiarity with regulatory requirements for clinical research, including GCP (Good Clinical Practice) and FDA regulations.
  • Skills:
    • Excellent organizational and project management skills.
    • Strong attention to detail and ability to maintain accurate study records.
    • Proficiency in clinical research software and data management tools.
    • Strong communication skills for coordinating with participants, research teams, and external partners.
    • Ability to multitask and manage multiple studies or projects simultaneously.
    • Knowledge of clinical trials, study design, and protocol implementation.
  • Attributes: Self-motivated, proactive, and able to work both independently and in a collaborative environment.

Express Employment Professionals is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

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