General Summary:

The Clinical Manager of Research, under the guidance and supervision of the Principal Investigator (PI) and the Medical Director, ensures the integrity and quality of clinical trials are maintained and conducted in accordance w/ federal, state, and local regulations, ICH/GCP guidelines, Institutional Review Board (IRB) approvals, and institutional policies and procedures. This position is primarily responsible for the accurate completion of visit procedures and collection of information from study patients according to protocols, and for protecting the health, safety, and welfare of research participants.

Essential Job Functions/Competencies

• Ensures compliance with each study's protocol by providing thorough review and documentation at each study visit
• Performs medical tests, including, but not limited to, patient vital signs, phlebotomy, and nursing assessments
• Administers investigational medications including oral, infusion and intravesical and perform drug accountability for all medications.
• Query patients for adverse events and notify PI to determine causality and Grading
• Provides accurate and timely data collection, documentation, entry, and reporting in both sponsor and Crio data bases
• Complete all required training - GCP, IATA and specific protocols requirements (ie: iwrs, edc, protocol training)
• Submit and maintain Regulatory Documents for all protocols during start up, maintenance and close out.
• Develop and Maintain institutional SOP's
• Communicates and collaborates with Patients, investigators, sponsors, irb and protocol vendors
• Responsible for Recruitment of patients and assessing eligibility requirements for protocols

Certifications, Licensures or Registry Requirements

• Active RN License for the state

Educational Requirements

• Bachelor's degree

Experience Requirement

• 1-3- preferred.