RHO

Clinical Research Associate II

Job Location US
ID
2021-1716
Type
Regular Full-Time

Overview

The Clinical Research Associate II (CRA II) performs and coordinates 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 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 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 is up to 80%.  Applicants must live within a 60 minute commute of a US metropolitan airport.

Responsibilities

  • 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 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 within the CRO, pharmaceutical or biotechnology industry
  • BA/BS, preferably in a life science, nursing, pharmacy or related field
  • Therapeutic experience in CNS, Rare Disease, Infectious Disease or Gene Therapy
  • 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

EOE. Veterans/Disabled

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