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Clinical Research Associate I
at Rho, Inc.
- Regular Full-Time
The Clinical Research Associate I (CRA I) role is integral to ensuring project success as part of a multi-disciplinary team that provides scientific, statistical, and operations and management support for clinical trials.
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. The CRA I will be responsible for supporting study team management, providing input into monitoring tool and process development, as well as training for newly assigned project CRAs.
This position requires up to 80% travel and is based in Durham, NC. This is an office-based position.
- Perform all site monitoring 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
- Contribute to the development of protocols, study tools, and materials as well as documentation for clinical trials
- Proactively drive project success, including collaborating with cross-functional team members, as well as Project Director, Principal Investigator, Sponsor and site staff
- Interact and collaborate with other CRAs
- 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 on-site and remote monitoring and study closure activities across multiple protocols
- BA/BS, preferably in a life science, nursing, pharmacy or related field
- Minimum of 3 years of work experience within the CRO, pharmaceutical, or biotechnology industry
- Approximately 0-2 years of on-site clinical monitoring experience and/or clinical trial support/regulatory document specialist experience. Minimum of 1 year of on-site monitoring experience preferred
- Proficient technical/scientific knowledge required for comprehension and execution of clinical protocols
- Strong organizational and logistics skills to ensure effective management of multiple sites and protocols within timeframes and on budgets
- Superior written and verbal communication skills
- Ability to work in a matrix environment
- Demonstrated ability to train and mentor clinical research staff preferred
- The ability to constructively interact directly with Sponsor personnel
- Computer literacy, including proficiency in MS Office
- Ability to perform up to 80% travel