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 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
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
Computer literacy, including proficiency in MS Office and use of EDC systems