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Clinical Research Associate II

Clinical Research Associate II

ID 
2017-1339
Job Location 
US-NC-Chapel Hill
Type 
Regular Full-Time

More information about this job

Overview

The Clinical Research Associate II (CRA II) performs and coordinates all aspects of the clinical monitoring process in accordance with ICH Good Clinical Practices, FDA guidelines, local regulations and Rho Standard Operating Procedures.

 

This position requires proven monitoring skills. The CRA II conducts site visits to assess site adherence to protocol and regulatory requirements as well as manages required documentation. The CRA II will also be responsible for ensuring the data remains audit ready and able to pass an audit by Rho, the Sponsor or a regulatory agency.

 

The CRA II will be part of a multi-disciplinary team that provides scientific, statistical, and operations and management support for federal clinical trials. In these trials, on-site monitoring is used in conjunction with extensive remote monitoring and site management. Thus, this role will work closely with the project manager, who has primary responsibility for site management, and the data manager.

 

Required to travel is up to 80%.  The ideal candidate will be located in the Raleigh/Durham/Chapel Hill, NC area, however will consider non-local canddiates who are willing to travel to and work in-office as needed.

Responsibilities

  • Perform all site monitoring visit activities, inclusive of all study visit types (PSV, SIV, IMV and COV)
  • Provide feedback to assist sites with resolution of detected deficiencies and corrective action needed, follow-up with sites until deficiencies are resolved
  • Draft clinical monitoring plans and contribute to the development of protocols, study tools, and materials as well as documentation for clinical trials
  • Provide mentoring, training, and co-monitoring of junior clinical team members
  • Develop and maintain effective working relationships with clinical sites and within Rho as well as ensure communication of project goals and critical requirements
  • Participate in the Clinical Operations community at Rho by contributing to internal initiatives and standard operating procedures for the administration and monitoring of clinical trials
  • Perform both onsite & remote monitoring and study closure activities across multiple protocols

Qualifications

  • Approximately 2-5 years of on-site monitoring experience
  • BA/BS, preferably in a life science, nursing, pharmacy or related field
  • Clinical background preferred
  • Proficient technical/scientific knowledge required for comprehension and execution of clinical protocols
  • High organizational and logistics skills to ensure effective management of multiple sites and protocols within timeframes and on budgets
  • Superior written and verbal communication skills
  • Demonstrate an understanding of medical/therapeutic area knowledge and medical terminology
  • Demonstrate the ability to train and mentor clinical research staff
  • Computer literacy, including proficiency in MS Office and use of EDC systems