Covance Clinical Research Associate - (Experience req'd) Unblinded - South/TX L USA in Houston, Texas
Must be located in South/TX USA
Covance 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
Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.