Rho is seeking CRAs and Contract CRAs to perform and coordinate all aspects of the clinical monitoring and site management in accordance with ICH Good Clinical Practices, FDA guidelines, local regulations and Rho Standard Operating Procedures.
These positions require proven monitoring skills and will conduct site visits to assess site adherence to protocol and regulatory requirements as well as manage required documentation. These individuals 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 individuals in these positions may also 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 travel is up to 80%. Applicants must live within a 60 minute commute of a US metropolitan airport.
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
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
Full-time CRAs will be expected to 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
Minimum of 2 years of on-site monitoring experience (minimum of 5 years is required for contract openings)
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 organization 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
Internal Number: 2018-1423; 2017-1374
About Rho, Inc.
Rho is a Contract Research Organization (CRO) with unsurpassed expertise, integrity, and passion for clinical research. Our dedication to providing outstanding clinical research is fueled by an unrivaled commitment to quality. Our distinct combination of expertise and insight delivers results in every phase of clinical research. We share the same level of involvement, commitment, and passion as our clients—a dedication to collaboration that delivers life-saving products with more efficiency and greater speed.