Covance

Senior Clinical Research Associate

LV
Job Number
2017-15335
Job Category
Clinical Research Associate
Position Type
Part-Time

Job Overview

We are currently looking for talented Senior Clinical Research Associates to work for us in a sponsor based model as our sponsor, a well-known mid-sized pharma company, is currently expanding their Clinical Operations team.  This is a part-time (0.8 FTE), permanent and home-based position.

 

Responsibilities:

  • 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
  • Review progress of projects and initiate appropriate actions to achieve target objectives
  • Organize and make presentations at Investigator Meetings
  • Act as contact for clinical trial supplies and other suppliers (vendors) as assigned
  • 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
  • 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
  • May act as a local client contact as assigned

Education

  • University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology
  • In lieu of the above requirement, candidates with four or more years of relevant clinical research experience in pharmaceutical or CRO industries will be considered*
  • Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries
  • Thorough understanding of the drug development process
  • Fluent in local office language and in English, both written and verbal

Experience

  • Minimum of four years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits)
  • Have a full understanding of Serious Adverse Event (SAE) reporting
  • Advanced site monitoring skills
  • Advanced study site management skills
  • Ability to work with minimal supervision
  • Good planning and organization 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 Ability to work within a project team
  • Works efficiently and effectively in a matrix environment

Preferred:     

  • One or more year’s additional experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred
  • Experience in complex studies is preffered
  • Experience in neurology / CNS is preffered

 

Why Covance?
At Covance, you will join like-minded professionals who, together, build our reputation as one of the world's largest and most respected contract research organizations. In choosing Covance, you will be part of a dedicated team that makes a difference in helping to deliver life-saving and life-enhancing medicines to people around the world.

 

We welcome your application and believe this decision may be the most rewarding career move you will ever make!

Education / Qualifications

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Experience

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