The senior clinical research associate assists in monitoring functions of Phase I-IV clinical pharmaceutical research studies using knowledge of the drug development process, Good Clinical Practices, FDA regulations and other relevant regulations. Provide clinical and technical support for CRA I and CRA II. Perform clinical trial initiation, monitoring and close-out activities in accordance with Standard Operating Procedures and Project Specific Operating Procedures. Assist with protocol review. Ensure the integrity of clinical data in drug studies. Review study protocols and provide feedback about implementation of protocol. Develop drug study specific monitoring plans. Collect, review and track regulatory documentation using electronic data capture. Assist in the development of study specific monitoring plans, annotated CRFs, monitoring conventions, tracking forms and other study-related documents.

Requirements – Bachelor's Degree or foreign degree equivalent in Biology, Microbiology, Biochemistry, Medicine, Pre-Medicine or Nursing and one year of experience in the job offered or one year of experience as a Clinical Research Associate or Clinical Study Coordinator. (Alternatively, employer accepts a 3 year diploma or foreign degree equivalent in Biology, Microbiology, Biochemistry, Medicine, Pre-Medicine or Nursing and three years of experience). Special requirements – Experience with monitoring functions of Phase I-IV clinical pharmaceutical research studies. Travel to various unanticipated client/customer sites required.

Education Level: BACHELORS DEGREE Work Days: Sun Mon Tues Wed Thur Fri Sat Work Shifts: 1st 2nd 3rd Rotating Split Contact Information Mail Resume to: 500 Carew Tower 441 Vine Street CINCINNATI OH 45202 Contact Name: Ms. Chrissy Disibio

---