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Clinical Research Associate II

Company: Covance
Location: Daytona Beach
Posted on: May 3, 2021

Job Description:

Are you ready to redefine whats possible, and discover your extraordinary potential at Covance? A career here provides the unique chance to create a lasting impact and difference in our patients 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, youll 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 Florida region but could be other regions occassionally***
Recommended:
- University or college degree, or certification in a related allied health profession from an appropriately accredited institution(e.g. nursing licensure)
- Minimum of 2 years of ClinicalMonitoring experience
Preferred:
- Thorough knowledge of Covance SOPs for site monitoring
Minimum Required:

- University or college degree, or ce1tification in a related allied health professionfrom anappropriatelyaccreditedinstitution(e.g. nwsinglicensure)
- Minimum of 2 years of Clinical Monitoirngexperience in a CRA role
- Ability to monitor study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines
- Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and foJlow up of SAEs
- Good planning, organization and proble m solving abilities
- Ability to work with minimal supervision
- Good communication and interpersonal skills
- Good analytical and negotiation skills
- Fluent in localoffice language and in English, both written and verbal
- Works efficiently and effectively in a matrix environment

Preferred:
One (1) or more additional years of experience in a related field (i.e. medical. clinical, pharmaceutica,l laboratory, research, data analysis, data management or technical writing) is preferred

#LI-ML1
#REMOTE

Keywords: Covance, Daytona Beach , Clinical Research Associate II, Other , Daytona Beach, Florida

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