Rho is a full-service contract research organization optimally sized to deliver results from clinical research with agility and adaptability. Maximizing profitability, stability, and planned growth has helped provide us with the experience, capacities, and capabilities of a larger organization—all without losing touch with our entrepreneurial passion. From our headquarters in Chapel Hill, North Carolina, we employ more than 400 creative and critical thinkers. We provide excellent service to some of the nation’s leading pharmaceutical, biotechnology, and medical device companies as well as a number of federal agencies. Our experienced teams help our clients bring new products to the marketplace in a wide range of therapeutic areas.
Post : Clinical Research Associate II
Job Description
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 part of a multi-disciplinary team that provides scientific, statistical, and operations and management support for federal clinical trials. In these trials, on-site monitoring is used in conjunction with extensive remote monitoring and site management. Thus, this role will work closely with the project manager, who has primary responsibility for site management, and the data manager.
Responsibilities
• Perform all site monitoring visit 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
• Draft clinical monitoring plans and 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 intiatives and standard operating procedures for the administration and monitoring of clinical trials
• Perform both onsite & remote monitoring and study closure activities across multiple protocols
Candidate Profile
• 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
Additional Information:
Location: USA
Qualification : BA/BS
Experience : 2-5 years
Industry Type: Pharma
Functional Area: CRA
End Date: 15th May, 2018
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