Senior CRA (Phase I)

Covance by Labcorp - Tampa, FL (30+ days ago)

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Job Overview:
Are you ready to redefine what’s possible, and discover your extraordinary potential at Covance? A career here provides the unique chance to create a lasting impact and difference in our patient’s lives. Joining our team will offer you a rewarding career, an opportunity to work in a high-energy & collaborative work place, along with access to comprehensive benefits. Your work will be meaningful, the patient outcomes are real, and the results are lasting. With the support of exceptional people from across the globe and an energized purpose, you’ll be empowered to own your career journey with mentoring, training and personalized development planning.

Our mission is to help our clients bring the miracles of medicine to market sooner - join us for your next career move.

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

General On-Site Monitoring Responsibilities:
Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review. Monitor data for missing or implausible data
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
Prepare accurate and timely trip reports
Manage small projects under direction of a Project Manager/Director as assigned
Serve as lead monitor for a protocol or project and may assist in establishing monitoring plans as assigned
Perform other duties as assigned by management

***Requires 60%+ travel within the US***

Minimum Required:
Univensity or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure) AND o a minimum of 4 years of Clinical Monitoring experience
In lieu of the above education requirement, external candidates with a minimum of 6 years recent clinical monitoring experience will be considered

Minimum Required:
4 years of Clinical Monitoring experience, preferably in a Phase I environment
Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs Advanced site monitoring skills
Advanced study site management skills
Advanced registry administration skills
Ability to work with minimal supervision
Good planning and organizational skills
Good computer skills with good working knowledge of a range of computer packages
Advanced verbal and written communication skills
Ability to train and supervise junior staff
Ability to resolve project-related problems and prioritizes workload for self and team Ability to work within a project team
Works efficiently and effectively in a matrix environment

One (1) or more additional years of experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred
Local project coordination and/or project management