Conducts site monitoring of clinical research studies according to Covance Standard Operating Procedures, ICH Guidelines and GCP
Provide clinical support for projects according to Covance Standard Operating Procedures, ICH Guidelines and GCP
Site management responsibility for clinical studies according to Covance Standard Operating Procedures, ICH Guidelines and GCP.
Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, with or without guidance; liaise with vendors; and other duties, as assigned
Responsible for aspects of registry management as prescribed in the project plans General On-Site
Monitoring Responsibilities:
o Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
o Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
o Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review
o Monitor data for missing or implausible data
o Ensure the resources of the Sponsor and Covance are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including
managing travel expenses in an economical fashion according to Covance travel policy Travel, including air travel, may be required and is an essential function of the job. Prepare accurate and timely trip reports
Perform CRF review, query generation and resolution against established data review guidelines, with or without direct supervision, on Covance or client data management systems, as assigned by management
Assist with the administration of clinical research projects, recruiting investigators, collecting investigator documentation and site management
Provide coverage for clinical contact telephone lines, as required
Update, track and maintain study-specific trial management tools/systems Generate and track drug shipments and supplies, as needed
Track and follow-up on serious adverse events as assigned Implement study-specific communication plan as assigned
Attend investigators' meetings, project team meetings and teleconferences, as needed Assist Senior CRA in managing investigator site budgets
Perform other duties as assigned by management
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