This position assists investigators as coordinator of a complex clinical research study; may be responsible for multiple research studies simultaneously, acting as a liaison with the sponsoring agency, monitoring and the study participants; responsible for managing and recording all phases of study protocol as required by sponsoring agency to ensure compliance.
Duties and Responsibilities:
• Coordinates screening and enrollment of clinical trial patients to ensure proper execution of assigned complex clinical research trials and to ensure that study protocols, SOPs, ICH-GCPs and regulatory requirements are met.
• Reviews physician-patient schedules and assesses patients for possible clinical trial enrollment.
• Educates patients and families during the informed consent process.
• Registers patients and participants to protocols.
• Ensures eligibility requirements are met and reviewed with the physician investigator.
• Ensures protocol-required patient testing is ordered and complete.
• Maintains record of recruitment strategies.
• Markets protocols as needed to meet recruitment goals.
• Coordinates clinical trial activities and research done at the inpatient and outpatient units.
• Gathers and verifies source documents
• Verifies the accuracy, completeness and timely submission of case report forms.
• Collaborates with the investigator to ensure protocol compliance in patient selection, treatment, dose modifications and response.
• Interview patients to assess adverse events, medication compliance, and patient-reported outcomes.
• Obtains follow-up data required when the patient is off active treatment.
• Corrects and resubmits data or answers queries within one week of receipt or as requested by the pharmaceutical company; reviews expectation reports; notifies research base of errors.
• Maintains drug inventory
• Maintains inventory of individual drug accountability records.
• Ensures treatment order is correct by reviewing protocol guidelines and calculating the dose prescribed.
• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
• Meets and addresses issues with study monitors, sponsors and regulatory agencies as appropriate.
• Respond to queries
• Participates in review and development of SOPs, and internal procedures.
• Analyzes and develops action plans to address findings, including development of CAPA reports
• Participates in development, revision and implementation of clinical, general and other applicable SOPs, Directives and internal procedures as required, ensuring consistency with GCP, regulatory, and/or Sponsor requirements
• Performs CRC, Reviewer and Unit staff duties if required
• Maintains adequate, accurate, complete and legible records
• Detailed review of subject and study documentation, CRFs and source documents
• Maintains current professional knowledge base of clinical research methodologies and regulatory requirements (FDA, TPD, etc.)
• Performs other tasks as assigned and as training and experience allow.
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