Clinical Research Associate II at Covance



At Covance, you can make a difference by helping to deliver life-saving and life-enhancing medicines to people around the world. Our commitment to this mission has resulted in Covance’s impressive history of company stability and growth. We’ve achieved these results by fostering a work environment that encourages, develops and leverages our team’s capabilities.

 

Covance’s ongoing success offers team members unsurpassed growth and career development opportunities. There is no better time to join us!


Job location : TAIWAN

Closing date : November 30, -0001

Job code : CRA2

Responsibilities:

  • May serve as lead monitor for a protocol or project and assist in establishing monitoring plans.
  • Review progress of projects and initiate appropriate actions to achieve target objectives.
  • Organize/make presentations at Investigator Meetings.
  • Report, write narratives and follow-up on serious adverse experiences.
  • Interact with internal work groups to evaluate needs, resources and timelines.
  • 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.

On-Site Monitoring Responsibilities:

  • Ensure that study staff has received the proper materials and instructions.
  • 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.
  • Prepare accurate and timely trip reports.

Qualifications:

  • Minimum of two years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits).
  • 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 follow up of SAEs.
  • University/college degree (life science preferred), or certification in a related allied health profession from an accredited institution (e.g., nursing certification, medical or laboratory technology).
  • Good planning, organization and problem solving abilities.
  • Ability to work with minimal supervision.
  • Good communication, interpersonal, analytical and negotiation skills.
  • Computer competency.
  • Fluent in local language as well as English, both written and verbal.

At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career.

 

Apply online at www.Covancecareers.com using requisition/position ID 14698. Please send English CVs only.

 

Covance is committed to diversity in the workplace and is an equal opportunity employer. (M/F/D/V). Your confidentiality and privacy are important to us.


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