Clin Res Assoc II
Raleigh, NC  / Durham, NC 
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Job Description
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 workplace, 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.


As a CRA you will berResponsible 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
?Responsible for all aspects of registry management as prescribed in the project plans
?Undertake feasibility work when requested
?Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor as assigned
?Negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned
?Complete process of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
?Independently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management
?Assist with training, mentoring and development of new employees, e.g. co-monitoring
?Co-ordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned
?Perform other duties as assigned by management

Education/Qualifications:

University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)

  • In lieu of the above requirement, candidates with two (2) or more years of relevant clinical research experience in pharmaceutical or CRO industries may be considered
  • Fluent in EnglishAdvanced site monitoring skills
  • Thorough knowledge of ICH Guidelines and GCP including basic understanding of regulatory requirements
  • Thorough knowledge of monitoring procedures
  • Basic understanding of the clinical trial process
  • Valid Driver's License
Experience:
  • Ability to monitor studies 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 follow up of SAEs
  • Ability to work with minimal supervision
  • Good planning and organization skills
  • Good computer skills with good working knowledge of a range of computer packages
  • Good communication and interpersonal skills
  • Good analytical and negotiation skills
  • Fluent in English, both written and verbal
  • Works efficiently and effectively in a matrix environment
  • Experience in monitoring Cardiovascular, Respiratory, Oncology, Diagnostic Imaging or Medical Device preferred.

Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran). Your confidentiality and privacy are important to us.

 

Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Experience
2 years
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