DESCRIPTION

This position will monitor clinical research projects in the Sanford Stem Cell Clinical Center's (SSCCC) Alpha Clinic. The Clinical Monitor uses skills as a seasoned, experienced research compliance professional with a full understanding of industry practices and organization policies/procedures to apply FDA, federal, state, and university regulations, policies, and guidelines, and promote best practices. Interacts frequently with investigators, persons in other organizational departments, and frequently with site staff and PIs outside the University. Interactions require the use of tact and independent judgment, knowledge of standards and best practices, and counseling to resolve a wide range of research compliance issues. Demonstrates good judgment in selecting methods and techniques for obtaining solutions.

This position is an integral part of the SSCCC Alpha Clinic portfolio. Incumbent will frequently interface and manage research trials primarily at the UC San Diego's SSCCC Alpha Clinic, with the potential of visiting up to eight additional Alpha Clinic sites in the California Institute of Regenerative Medicine (CIRM) network. The clinical monitor will work under the general supervision of the SSCCC Alpha Clinic Director of Clinical Research and Director of SSCCC, SSCI Executive Director and SSCI Director.

The incumbent is responsible for adherence to FDA regulations, study protocols, SOPs, GCP and ALCOA guidelines, for all sites conducting stem cell studies. Also responsible for ensuring the accuracy and data integrity at sites as well as appropriate documentation as outlined in FDA guidelines for clinical trials. Incumbent manages clinical research sites, identifying and introducing new monitoring procedures to optimize team performance, overseeing the execution of the Standard Operating Procedures, protocol implementation, and overseeing study close-out in order to maintain regulatory compliance and standardize "Best Practices" at each site.

Monitor defines goals and progress, contributes innovative solutions to implementation of studies, and determines clinical needs of research projects. Other duties include developing productivity and data management tools and working with other groups to provide operational and strategic support. Independently conducts study site visits that include training and leading site personnel (PIs, study coordinators, physicians) in protocol procedures and compliance, implementation, and administration of stem cell clinical tests. The incumbent also facilitate and attend meetings as well as participate in conference calls with trial Project Directors and other SSCCC team members as required. Performs other duties as assigned.

MINIMUM QUALIFICATIONS

• Seven years of related experience, education/training, OR a Bachelor’s degree in related area plus three years of related experience/training.

• Demonstrated self-discipline and sound, independent judgment completing complex assignments. Monitors must be able to work independently as well as a team to ensure the success of our trials. SSCCC Alpha Clinical Monitors function as ambassadors to CIRM sites and therefore must possess the ability to make independent judgments that will not endanger the integrity of the trial, trial data, or most importantly, participant safety per UCSD guidelines.

• Thorough knowledge and ability to apply all relevant Federal, state, and university regulations, policies, and federal guidance documents. Must be current with CITI training, GCP, and have a thorough knowledge of each of the trial protocols that they will be monitoring. Knowledge of FDA regulations and regulatory compliance is also critical as it pertains to each study.

• Thorough knowledge and experience with quantitative and qualitative research design; scientific research concepts and terminology. The incumbent is expected to contribute to the design of the monitoring plan for each trial, and therefore, must have experience and knowledge of trial and research designs, particularly those related to the monitoring of the trial/study.

• Demonstrated proficiency in public speaking, and writing. Must have exceptional communication skills since they work very closely with site personnel, which includes study coordinators, nurses, doctors, administrators, etc. They are also frequently asked to present at Investigator Meetings, which requires speaking to diverse and large audiences. Monitors must also have excellent writing skills since they are required to complete and submit monitoring reports related to each of their site visits. This documentation is essential to the conduct of each trial.

• Conflict of Interest: Understanding of stock options, consulting agreements and other corporate documents related to research and analysis of potential conflicts of interest.

PREFERRED QUALIFICATIONS

• Clinical Trials certification preferred.

• Knowledge/familiarity of any EDC, eRegulatory Binder, or eTMF platforms.

• Awareness of COI in regards to UCSD/CIRM disclosure reporting to ensure that sites are not approved to begin screening participants until COI has been reviewed and no conflicts have been determined/and or have been resolved.

SPECIAL CONDITIONS

• Employment is subject to a criminal background check.

• Must be willing to work onsite at the SSCCC Alpha Clinic. May be required to travel.