Must be located on the East Coast
Labcorp Drug Development is seeking an Unblinded CRA to primarily focus on drug accountability at a site level across a range of protocols and therapeutic areas.
Essential Job Duties:
- 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; liaise with vendors; and other duties, as assigned
- Responsible for all aspects of site management as prescribed in the project plans
- Travel, including air travel, may be required and is an essential function of the job.
- Prepare accurate and timely trip reports
- Review progress of projects and initiate appropriate actions to achieve target objectives
- Organize and make presentations at Investigator Meetings
- Participate in the development of protocols and Case Report Forms as assigned
- Participate in writing clinical trial reports as assigned
- Interact with internal work groups to evaluate needs, resources and timelines
- Act as contact for clinical trial supplies and other suppliers (vendors) as assigned
- Responsible for all aspects of registry management as prescribed in the project plans
- Undertake feasibility work when requested
- Conduct, report and follow-up on Monitor Quality Control Visits (MQC) or Quality Control Visits (CQC) when requested
- Independently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management
- University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate.
- A minimum of 1 year of Onsite Clinical Monitoring experience is preferred
- Early Stage experience is preferred.
- Thorough knowledge of ICH Guidelines and understanding of local regulatory requirements
- Thorough knowledge of monitoring procedures
- Basic understanding of the drug accountability process
- Valid Driver's License
- Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
- Good planning, organization and problem-solving abilities
- Ability to work with minimal supervision
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