GENERAL SUMMARY

Working under clinical research managers and tasked with administering clinical trials. Responsibilities include managing clinical trials and collecting data, informing participants about study objectives, and administering questionnaires.

ESSENTIAL JOB FUNCTION/COMPETENCIES

• Provide subject care and data collection procedures in adherence with the assigned study protocol and in accordance with good clinical research principals..
• Review subject charts, database records, and other sources to screen and identify potential subjects for inclusion in study based on criteria described in the protocol.
• Coordination and management of the clinical trial, communication with sponsor and authorities, visit coordination, sampling, time management and product accountability.
• Data collection and management, collection and development of source documents, use of CRFs, managing patient registration, AEs, filing and archiving, managing monitoring visits, dealing with queries.
• Maintain accurate records of the receipt, inventory, and dispensation of study drug and obtain and coordinate subject blood samples, cultures, tissues, and other specimens for laboratory analysis as described in study protocol.
• Patient visits, data collection and transcription/EDC, prepare for monitor visits, protocol adherence to include height, weight, blood pressure, respirations, pulse temperature, O2 saturation.
• Schedule appointments and organize materials to be used during study visits and ensure that all required tests are completed for each study visit per protocol.
• Includes initial study start-up information/ requirements, dissemination of updated Investigator's Brochures, protocols and informed consent information, online training initiated by sponsor, review of correspondence throughout study.
• Completes Source Documentation-which includes completing and uploading all necessary documents to CRIO and maintaining all charts properly.
• Medical Assessment-includes obtaining information from patient or chart regarding name of medication, start and stop dates, dose, and indication.
• Biological Sampling Collection/Packaging/Shipping - includes serum and/or tissue collection, processing, packaging and shipping per study specific requirements.
• Case Report Form (CRF) Entries and Management - includes data entry, query resolution in paper and/or electronic CRFs.
• Investigational Product (IP) Management - includes receiving IP supplies, IP accountability, monitoring of temperature controls, destructions or return of IP.
• Develop and/or Maintain Essential Documents - includes study specific training documents, study specific logs, patient questionnaires, patient pill diaries, lab requisition forms, other study specific forms.
• Supply Chain Maintenance-Supplies Inventoried, stocking, organizing, and resupply order placed as required. Completed in Envi system.
• Study Coordination- rooming, administer questionnaires, scheduling scans, set up room for procedures and wipe and clean equipment after procedures and visits.
• Obtain/Maintain all required training- GCP, IATA,CPR Occasionally help the study coordinators at other offices such as the surgery center.
• Performs other position related duties as assigned.