Capital Associated Industries, Inc.
  • Durham, NC, USA
  • Full Time

Cato Research is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Cato is a non-laboratory environment.

 

We are currently recruiting a Clinical Research Associate II to join our team.  Responsibilities include the following:

 

  • Travels to investigational sites to verify that: the rights and well-being of human subjects are protected; the reported trial data are complete, accurate, and verifiable against source documents; and that the trial is conducted in compliance with the currently approved protocol, Good Clinical Practices, applicable regulations and applicable standard operating procedures (SOPs).
  • Conducts investigational site visits (evaluation, initiation, periodic and termination) in order to verify proper storage conditions, accountability, and disposition of the investigational products; maintenance of up-to-date and accurate investigator's study files; and accurate recording and reporting of adverse events.
  • Writes and submits written reports of investigational site findings and updates tracking systems as required.
  • May be involved in organizing or participating in investigator's meetings, clinical study report writing, and the development of protocols, informed consent forms, study procedure manuals, monitoring plans, and case report forms.
  • Maintains a high level of professional expertise through familiarity with regulatory and clinical literature and continuous education.

 

Requirements:

 

  • Requires a B.A./B.S., R.N., B.S.N. degree or equivalent experience.
  • Minimum of 3 -5 years' experience as a CRA with primary site monitoring responsibilities in the pharmaceutical, biotechnology, medical device, or CRO industry, or equivalent experience.
  • Valid driver's license required.
  • Knowledge of regulatory requirements and ICH-E6 guidelines required.
  • Ability to manage competing demands and to respond cooperatively with shifting priorities.
  • Demonstrates attention to details. Plans and organizes with little supervision.
  • Keeps abreast of industry standards and conditions.
  • Identifies and solves problems in a timely manner.
  • Ability to effectively communicate with peers, project team, upper management both internally and externally, and external healthcare professionals.
  • Proficiency with various computer applications such as Word, Excel, and Power Point, required: experience with EDC systems preferred

 

 

Equal Employment Opportunity and Affirmative Action

We are committed to Equal Employment Opportunity and Affirmative Action. We recruit, hire, train and promote persons in all job titles and ensure that all other personnel actions are administered without regard to race, religion, color, national origin, citizenship, sex, age, veteran status, disability, genetic information, or any other protected characteristic. Cato Research is committed to providing reasonable accommodations to employees and applicants with disabilities to the full extent required by the Americans with Disabilities Act ADA. If you feel you need a reasonable accommodation pursuant to the ADA, you are encouraged to contact us at 919.361.2286

 

Capital Associated Industries, Inc.
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