Job Description

Summary:
The Clinical Research Coordinator plans, directs, and coordinates clinical research projects. This role involves evaluating and analyzing clinical data, ensuring compliance with regulations, and exercising independent judgment on significant matters.

Responsibilities:

• Perform study subject visits, including:
  • Screening and recruiting subjects.
  • Dosing and administering study drugs or implementing study methodologies.
  • Accounting for study drugs.
  • Communicating with subjects and medical providers, including the Principal Investigator and Sub-Investigators.
  • Collecting, labeling, storing, and shipping specimens.
  • Entering patient and research data into designated systems.
  • Maintaining patient charts and resolving research queries.
• Ensure adherence to Good Clinical Practice (GCP) standards.
• Monitor study activities for compliance with protocols, regulations, and site requirements.
• Maintain records of study activity, including case report forms, drug dispensation records, and regulatory forms.
• Track subject enrollment and document dropout information, communicating updates as directed.
• Assess eligibility of potential subjects through screenings, medical record reviews, and discussions with healthcare professionals.
• Oversee subject enrollment, ensuring informed consent is properly obtained and documented.
• Record and report adverse events and side effects to oversight agencies as necessary.
• Prepare for and participate in quality assurance audits by study sponsors or regulatory groups.
• Create and maintain study-related documents such as protocol worksheets, procedural manuals, and progress reports.
• Evaluate proposed study protocols for factors such as data management plans and subject risks.
• Provide instruction to research staff on study standards and procedures.
• Collaborate with investigators and management to prepare reports or presentations on study results and procedures.
• Communicate with laboratories or investigators regarding findings.
• Stay updated on clinical research trends through literature review, continuing education, and conferences.
• Order drugs or devices needed for study completion.
• Document findings in clinical trial management systems (CTMS) and other platforms as directed.
• Travel to investigator meetings, company sites, or sponsor-required meetings as needed.
• Perform additional duties as assigned, including those typically handled by research assistants.

Requirements:

• Knowledge of medical terminology and principles of administration.
• High school diploma or degree in nursing or a health-related field.
• At least 2 years of on-the-job training as a clinical research assistant or study coordinator.
• Completion of continuing education certifications, including:
  • IATA (dangerous goods handling).
  • GCP (Good Clinical Practice).
  • BLS/Phlebotomy course (if required).
  • CPR course (as arranged by the company).
  • Stericycle training during the first week of employment.

Physical Requirements:

• Prolonged periods of sitting at a desk and working on a computer.
• Periods of standing and walking around the office.
• Ability to lift up to 20 pounds.
• Exposure to human bodily fluids.
• Occasional night and weekend work schedules.
• Possible overtime as needed.
• Travel to sponsor-required meetings as necessary.
• Work performed primarily in a clinical or office environment.

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