Assistant Director of Clinical Research
Salary: Commensurate with Experience
Title: Assistant Director of Clinical Research
Category: Management and Professional
Department: Sponsored Pgm Admin Services
Date Posted: 08/29/2017
Position Information: The Assistant Director of Clinical Research (ADCR) works independently and proactively with decision-making responsibility under the general consultative direction of the Director, Sponsored Programs Administration. The ADCR is responsible for providing contracting services for clinical (drug and/or medical device) trials and other extramurally-funded clinical research projects, such as pre-clinical and observational studies. The ADCR will serve as the lead contract and grant officer for all sponsored programs administration activities associated with UCR's School of Medicine The duties of the ADCR include, but are not limited to: reviewing, endorsing and submitting proposals to sponsors; reviewing required prior approvals for research projects; conducting comprehensive analysis of a variety of awards (e.g., sponsor-initiated and investigator-initiated clinical trial agreements related to clinical/research grants, outgoing clinical sub-agreements, amendments, material transfer agreements related to clinical research, and confidentiality agreements); drafting, negotiating, and executing such awards with industry (e.g., pharmaceutical companies and contract research organizations), non-profit, state, and federal sponsors, on behalf of The Regents, in compliance with University policies and applicable Federal and state laws; providing on-going administrative management services during the term of the award (e.g. negotiating and executing award modifications); interacting with a variety of campus and University of California system-wide offices to facilitate the management, administration and conduct of clinical and other sponsored research; participating in the development and delivery of campus training related to clinical research; and understanding evolving trends in clinical trial research.
Minimum Requirements: Progressively responsible and recent experience drafting, negotiating, and finalizing clinical trial agreements, as well as confidential agreements and other research-related contracts, grants, and subcontracts. Ten years of related work experience.
Leadership and mentoring skills to develop and oversee less experienced analysts.
Demonstrated attention to detail and accuracy.
Expertise in the areas of fiscal management, human/animal subject compliance, intellectual property, conflict of interest, procurement, property management, environmental health and safety, and human resources (for academic and staff positions).
Advanced ability to organize workload in the face of competing priorities and to complete work assignments on a timely basis despite frequent interruptions.
Working knowledge of applicable policies, Federal and State regulations, and industry standards relating to contract authority, use of human subjects, research regulatory compliance requirements, subject injury and indemnification, intellectual property, copyright and patent law, confidentiality, publication rights, Federal and California privacy laws (i.e., HIPAA and CMIA), access to records, appropriate overhead rates, coverage analysis, record retention requirements for FDA-regulated clinical trials, and the ability to develop expertise on many such policies, regulations and industry standards.
Demonstrated knowledge of electronic proposal submission processes and funding mechanisms employed by extramural sponsors.
Ability to perform highly complex financial analysis and customized reporting.
Demonstrated advanced knowledge of generally accepted accounting, fiscal and reporting principles.
Expert knowledge of federal, state and non-profit sponsor regulations, policies, requirements, procedures and areas of interest.
Expert knowledge of pertinent federal and non-Federal sponsor regulations including OMB Circulars, the NSF and PHS Grants Policy Statements, Federal Acquisition Regulation, patent and copyright law, and cost-accounting standards.
Excellent negotiation skills sufficient to arrive at mutually agreeable terms from a less than optimal starting position.
Superior oral communications skills (which demonstrate the ability to effectively convey and explain information, influence outcomes and tactfully deal with diverse people, situations, and ideas) and superior written communications skills (which demonstrate the ability to draft clear, concise correspondence, specifications, documentation, and analytical reports).
Demonstrated expert level competence in the use of spreadsheet and database software in financial analysis, fiscal management and financial reports.
Expert knowledge and understanding of the compliance and sponsor policies related to research administration.
Preferred Qualifications: Five or more years of hands-on comprehensive experience drafting, negotiating, and finalizing clinical trial agreements, confidentiality agreements, and other clinical research-related awards with industry, non-profit, state, and Federal sponsors.
Avanced knowledge of intellectual property principles, policies, regulations, practices and the technical and legal issues affecting the protection, use and exploitation of intellectual property.
Advanced ability to develop and maintain effective working relationships within a diverse, multicultural, environment.
Advanced ability to identify complex problems and implement appropriate solutions.
Working knowledge and general understanding of the interests, perspectives, rights and responsibilities of University faculty, administrators, subcontractors, and sponsors related to the administration of clinical trials and other research-related projects.
Additional Information: In the Heart of Inland Southern California, UC Riverside is located on nearly 1,200 acres near Box Springs Mountain in Southern California; the park-like campus provides convenient access to the vibrant and growing Inland region. The campus is a living laboratory for the exploration of issues critical to growing communities'air, water, energy, transportation, politics, the arts, history and culture. UCR gives every student, faculty and staff member the resources to explore, engage, imagine and excel.
UC Riverside is recognized as one of the most ethnically diverse research universities in the country boasting several key rankings of which we are extremely proud.
- Washington Monthly (August 2016) ranked UC Riverside 12th in the nation in its annual University and College Survey. \
- Education Trust placed UC Riverside 9th in the nation for closing the graduation gap between black and white students by 1.7 percentage points.
- In QS World University Rankings 2016/2017, UC Riverside's Department of Philosophy is #1 in the world for the frequency with which published papers are cited by other philosophers.
- U.S. News and World Report Survey (September 2016) ranked UC Riverside 118th overall; earns "Great Schools, Great Prices."
- Shanghai Jiao Tong University (August 2016) Academic Ranking of World Universities ranked UC Riverside among the top 151 to 200 institutions. This survey bills itself as "the most trustworthy precursor of global rankings of the world's top 500 universities."
- U.S. News and World Report's Best Graduate Schools (2016) including:
- Graduate School of Education - 62nd among ranked schools
- Bourns College of Engineering - 71st among ranked schools
For information about our generous employee benefits package, visit: Employee Benefits Overview