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.
Description: Summary Responsible for the overall maintenance of the physical plant, under the direction of the Maintenance Supervisor and Community Manager. Essential Duties and Responsibilities Include the following. Other duties may be assigned. Participate...
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