Clinical Research Associate - (Experience req'd) Unblinded - East - NE or SE

Company: Labcorp
Location: Orlando
Posted on: October 12, 2021

Job Description:

Job Overview:

Unblinded CRA

Must be located in the East (NE or SE) Regions of the USA

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

#LI-Remote

Education/Qualifications:

• 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.

Experience:

• 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

Keywords: Labcorp, Orlando , Clinical Research Associate - (Experience req'd) Unblinded - East - NE or SE, Other , Orlando, Florida