Administrative Director of Research

Children’s Specialists of San Diego, Inc (CSSD) is a medical group comprised of over 150 pediatric sub specialists in over 26 specialty areas.   Our Group was formed 30 years ago and has experienced steady growth.   Our success is based on strong quality, financial and operational measures.  We are affiliated with both Rady Children’s Hospital-San Diego and UCSD Pediatric program.    Due to continued growth of the organization, we are currently seeking an experienced professional as Administrative Director of Research.   

 

 

Under the general supervision of the CSSD Research Director (a physician), has responsibility, authority and accountability for the operation of the research program for CSSD.  Oversees the daily operations of the clinical trials/research program by monitoring office and clinical activities, interfacing with researchers and others regarding clinical trials activities, as well as efficient operations and timely implementation protocols.

 Maintains compliance with institutional, state and federal regulations by monitoring and evaluating the quality and appropriateness of clinical trial activities throughout CSSD. Coordinates fiscal responsibility for the program by developing annual budget and recommending rate schedules, reviewing monthly operational reports, and promoting cost containment activities to promote fiscal viability and budget neutrality.  Oversees the fiscal tracking of all research projects by following and accounting for subject accruals, fund transfers, reconciling accounts, time lines, data analysis, and reporting on fiscal standing of each project to the Principal Investigator and Research Director. Serves as the main contact and legal contract reviewer and negotiator for industry sponsors for contract services for clinical investigational drug and device trials and as main contact for UCSD sub-contracts for research projects to be performed by CSSD.   Reviews sponsor-proposed contract terms of Confidentiality Disclosure Agreements and Clinical Trial Agreements, communicates when needed with CSSD’s general counsel to ensure proposed and/or revised terms are consistent with CSSD standards, work to ensure that CDA’s and CTA’s are executed in a timely manner.   Reviews and approves prospective contract and subcontract language and terms as necessary. Maintains a control system for all contracts to ensure all relevant parties remain apprised of provisions requiring compliance.  Provides leadership in quality performance by establishing systems to improve efficiency and customer satisfaction, developing and revising Policies and Procedures for research administration and for clinical trials and devices and correcting deficiencies to ensure a standard of quality research throughout CSSD.   Participates in meetings and task forces, engaging in projects or assignments to further the research objectives of CSSD.   Ensures all projects have appropriate resources, permissions from Divisions or other outside entities they may impact, contracts or agreements, and follow research policies and procedures.   Represents the research program to other departments, UCSD and RCHSD and facilitates interdepartmental collaboration by interfacing with other departmental directors and staff and by participating in meetings and committees. Represents the research program to the community, industry sponsors, research organizations, physician groups, donors and consumer groups by providing educational presentations and publications in order to advance the goals of the program. In coordination with CSSD Research Director, enhances program development by recruiting quality sponsored trials and physician investigators in order to expand the quantity of quality trials able to be performed at CSSD.  Identifies potential research projects based on review of formal protocol and research designs for applicability to available patient populations and investigator pool.   Ensures compliance with Human Subject Protection guidelines and serves as a resource for investigators and others on matters involving subject informed consent preparation and implementation, serious adverse event reporting, processing and implementing protocol amendments, IND/Medwatch report review and reporting, clinical investigational brochure change reporting, annual continuing review requirements, and all other communications that interface with the IRB.

 

Required:

§         Bachelor degree in health related field required.

·        3-5 years experience in similar position

·        Working knowledge of clinical trials and research administration.

·        Prior leadership in a related field.

·        Intermediate to advanced level computer skills required to perform the job functions such as MS Office and databases.

·        Proven knowledge of basic accounting principals, budgets and finance.

·        Proven knowledge of contracts and contracts language

 

Preferred:  

·        Advanced degree in health related field preferred

 

We strive to create an environment that is comfortable and values individuals for their skills and contributions to the organization.   We offer a strong compensation and benefits package, including Paid Time Off and a very generous 401(k) Plan.   

 

If you possess the skills and interest in joining an organization with the vision of being the premier provider of healthcare to infants, children, adolescents and mothers with high-risk pregnancies, through excellence in clinical care, research, teaching and advocacy, we want to hear from you!    Please submit your resume, with salary requirements, to our HR Director:   pkjones@rchsd.org .     EOE M/F/D/V