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Sr. Clinical Research Associate

Sr. Clinical Research Associate

ID 
2017-1357
Job Location 
US-NC-Chapel Hill
Type 
Regular Full-Time

More information about this job

Overview

The Senior Clinical Research Associate (Sr. CRA) role is integral to driving project success. This position will perform and coordinate all aspects of the clinical monitoring and site management process in accordance with ICH Good Clinical Practices, FDA guidelines, local regulations and Rho Standard Operating Procedures.

 

This position requires proven monitoring skills. The Sr. CRA conducts site visits to assess site adherence to protocol and regulatory requirements as well as manages required documentation. The Sr. CRA 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 Senior CRA will be responsible for supporting study team management by providing input into monitoring tools and process development as well as training for newly assigned project CRAs..

 

Required to travel up to 80%. Applicants must live within a 60 minute commute of a US metropolitan airport.

Responsibilities

Responsibilities and duties include, but are not limited to:

  • Perform all site monitoring visit activities, inclusive of all study visit types (PSV, SIV, IMV and COV)
  • Participate in the site selection process with oversight from the Clinical Team Lead role
  • Provide feedback to assist sites with resolution of detected deficiencies and corrective action needed, follow-up with sites until deficiencies are resolved
  • Contribute to the development and review 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
  • Attend and present at meetings and conferences, including Investigator Meetings
  • Participate in the RFP process, including business development meetings
  • 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

Minimum Requirements:

  • 5+ years of on-site monitoring experience within the CRO, pharmaceutical, or biotechnology industry
  • BA/BS, preferably in a life science, nursing, pharmacy or related field
  • Broad range of therapeutic experience
  • Superior written and verbal communications skills
  • Demonstrated understanding of medical/therapeutic area knowledge and medical terminology required for comprehension and execution of clinical protocol
  • Demonstrated ability to train, mentor, and lead clinical research staff
  • The ability to constructively interact directly with sponsor personnel

 

EOE. Veterans/Disabled