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 a part of a multi-disciplinary team that provides scientific, statistical, operations, and management support for commercially or federally funded clinical trials.
Required to travel is up to 80%. Applicants must live within a 60 minute commute of a US metropolitan airport.
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
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, with sponsors, 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 activation and closure activities across multiple protocols
May participate in drafting Clinical Monitoring Plans and Templates
Approximately 2-5 years of on-site monitoring experience
BA/BS, preferably in a life science, nursing, pharmacy or related field
Clinical background preferred
Broad range of therapeutic experience
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
Demonstrated ability to train and mentor clinical research staff
Computer literacy, including proficiency in MS Office and use of EDC systems