Clinical Research Coordinator

4 weeks ago


Hialeah, Florida, United States Superior Associates in Research Full time
Job Summary

The Clinical Research Coordinator will be responsible for managing clinical research studies, including recruiting and screening patients, coordinating study visits and procedures, maintaining study records, and ensuring adherence to study protocols.

Key Responsibilities:

  • Manage clinical research studies, including patient recruitment and screening, data collection, and study documentation.
  • Ensure compliance with study protocols, regulations, and ethical principles.
  • Maintain accurate records and manage study budgets.
  • Communicate effectively with study team members, patients, and sponsors.
  • Monitor study activities to ensure compliance with protocols and with relevant local, federal, and state regulatory and institutional policies.
  • Assess eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians and nurses.
  • Oversee subject enrollment to ensure that informed consent is properly obtained and documented.
  • Record adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies.
  • Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.
  • Identify protocol problems, inform investigators of problems, or assist in problem resolution efforts such as protocol revisions.
  • Prepare study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports.
  • Review proposed study protocols to evaluate factors such as sample collection processes, data management plans, and potential subject risks.
  • Participate in preparation and management of research budgets and monetary disbursements.
  • Instruct research staff in scientific and procedural aspects of studies including standards of care, informed consent procedures, or documentation procedures.
  • Collaborate with investigators to prepare presentations or reports of clinical study procedures, results, and conclusions.
  • Communicate with laboratories or investigators regarding laboratory findings.
  • Review scientific literature, participate in continuing education activities, and/or attend conferences and seminars to maintain knowledge of clinical studies affairs and issues.
  • Order drugs or devices necessary for study completion.
  • Solicit industry-sponsored trials through contacts and professional organizations.

Requirements:

  • Knowledge of biological and medical terminology.
  • Understanding of the principles of administration and management.

Education and Experience:

  • Bachelor's degree in a life science or related field preferred.
  • Five to 10 years of related experience required.

Physical Requirements:

  • Prolonged periods of sitting at a desk and working on a computer.
  • Must be able to lift up to 15 pounds at times.


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