#TP100533 Regulatory Research Coordinator
Position available through UCSD Temporary Employment Services (TES). Employment through TES is an excellent way to gain valuable UCSD experience and get your foot in the door for career positions. TES employment includes medical coverage, paid vacation & sick time, paid holidays, as well as training and development opportunities!DESCRIPTION
Under general supervision, the Regulatory Coordinator provides regulatory support and project management for product development activities related to UC San Diego Clinic's current clinical studies. The incumbent interacts with departments/agencies involved in clinical research including Research Compliance and other regulatory agencies pertinent to clinical research with an emphasis on human subject protection, subject consents, and diverse IRB policies applicable for UC San Diego Clinic members. The incumbent works closely with various functional areas and study teams in developing regulatory strategies, facilitating communications with regulatory agencies, and preparing and submitting regulatory documentationQUALIFICATIONS
Theoretical knowledge in a biological, psychological, life science or related discipline.
Bachelor's degree with three to seven years of relevant experience or an equivalent education and experience.
Demonstrated experience producing clinical regulatory documents, including proposals, consents, adverse event reports and close out documents.
Knowledge of evolving US regulations, guidelines, and specifications applicable to clinical research.
Experience interpreting regulations, guidelines, and precedents related to drugs and biological development.
Certified Clinical Research Coordinator or PMPSPECIAL CONDITIONS
Background check and medical screening are required.