General Information
| Job Description | RSCH ADM 5 | Working Title | Assistant Director of Clinical Research |
|---|---|---|---|
| Job Code | 000387 | Grade | 25 |
| Department Name | Sponsored Pgm Admin Services - D01158 | Department Head | |
| Supervisor | Effective Date | 08/01/2016 |
Position(s) Directly Supervised
| Job Code | Title | FTE |
|---|
Generic Scope
| Recognized organization-wide expert. Has significant impact and influence on organizational policy and program development. Regularly leads projects of critical importance to the organization; these projects carry substantial consequences of success or failure. May direct programs with organization-wide impact that include formulating strategies and administering policies, processes, and resources. Significant barriers to entry exist at this level. |
Custom Scope
| Having wide-ranging experience, uses contracts and grants concepts and organization objectives to assess and resolve the most complex contracts and grants issues having organization-wide impact. Given scope and impact, this role only exists in a central research administration organization. Manages the most complex transactions. Advises on the most complex proposals, including those involving large collaborations, international collaborators, complex contracts. Reviews research / training contract and grant proposals to extramural sponsors to ensure the proper commitment of institutional resources and compliance with institutional and sponsor policies. Proposals and contracts have direct organization-wide impact. Eligible for full delegation of authority to submit proposals on behalf of the organization and to act on behalf of the organization with federal, state and non-profit sponsors of extramurally funded grants, contracts, cooperative agreements and subcontracts and in acceptance of same. Serves as signing authority for less experienced staff. May serve as a staff manager and oversee staff, or may serve as a subject matter expert and is often recognized as an expert for the organization in the industry in a particular area, such as federal contracts, state contracts, subcontracts or information systems, or sponsored project administration and compliance. |
Department Custom Scope
| 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. |
Education & Experience Requirements
Education Requirements
| Degree | Requirement |
|---|---|
| Bachelor's degree in related area and/or equivalent experience/training. | Required |
| Ph.D., J.D., or Master's degree in a related field. | Preferred |
Experience Requirements
| Experience | Requirement |
|---|
License Requirements
Certification Requirements
| Certification | Requirement |
|---|
Educational Condition Requirements
| Condition | Requirement |
|---|
Key Responsibilities
| Description | % Time |
|---|---|
| Orients, trains and provides guidance to new or less experienced staff. | 5 |
| Directs and ensures complete and accurate collection of research management data at all stages of the contract and grant life cycle. | 5 |
| Independently oversees award reporting and closeout. | 5 |
| Communicates/teaches advanced/expert research administration such as compliance focused concepts at campus, national, organization level meetings. | 5 |
| Approves reviews conducted by entry-level analysts. Approves/signs-off submission of pre-award update information requested by sponsor representatives before issue of awards. | 5 |
| Independently negotiates terms and conditions of the most complex research grant, contract and subcontract proposals and awards from various sponsors. | 20 |
| Directs, initiates and designs analyses of federal, state, and university policy and assists with developing and writing office and organization policy and procedures. | 5 |
| Maintains and develops professional relationships with sponsor representatives. | 5 |
| Independently detects areas where new regulations need to be understood and implemented. | 5 |
| Initiates and coordinates policy exception requests, and briefs the Director of SPA, as appropriate, on unresolved problems or issues, and recommends creative solutions. | 5 |
| Conducts review, advanced analyses, and coordination of requests for institutional or sponsor prior approvals, such as no cost time extensions, re-budgeting, changes to work scope, and changes in project personnel. | 5 |
| Provides advice to deans, departments chairs, center directors, faculty and staff regarding sensitive, critical, and/or complex clinical trials, sponsored programs and material transfer issues. | 5 |
| Interacts and works closely with other central administrative offices (e.g., Fiscal Services, Campus Counsel, Material Management, Environmental Health and Safety, etc.) and with UC system-wide offices at the Office of the President (e.g., Research Administration Office, Office fo Technology Transfer, etc.) to facilitate the management, administration, and conduct of UCR's sponsored programs. | 5 |
| Networks with peers among the UC medical school campuses, and also on a national basis, and stays abreast of industry-wide best practices, trends, and issues of key clinical trial agreement terms. | 5 |
| Endorse sponsored program proposals and awards on behalf of The Regents of the University of California within the delegated signature authority. | 10 |
| The ADCR shall perform additional sponsored program activities as reasonably assigned. | 5 |
Knowledge, Skills & Abilities
| Knowledge/Skill/Ability | Requirement |
|---|---|
| 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. | Required |
| Expert knowledge and understanding of the compliance and sponsor policies related to research administration. | Required |
| 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). | Required |
| Expert knowledge of federal, state and non-profit sponsor regulations, policies, requirements, procedures and areas of interest. | Required |
| Ability to perform highly complex financial analysis and customized reporting. | Required |
| Demonstrated advanced knowledge of generally accepted accounting, fiscal and reporting principles. | Required |
| Demonstrated expert level competence in the use of spreadsheet and database software in financial analysis, fiscal management and financial reports. | Required |
| Leadership and mentoring skills to develop and oversee less experienced analysts. | Required |
| 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. | Required |
| 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. | Required |
| 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). | Required |
| Demonstrated knowledge of electronic proposal submission processes and funding mechanisms employed by extramural sponsors. | Required |
| Excellent negotiation skills sufficient to arrive at mutually agreeable terms from a less than optimal starting position. | Required |
| Advanced ability to organize workload in the face of competing priorities and to complete work assignments on a timely basis despite frequent interruptions. | Required |
| Demonstrated attention to detail and accuracy. | Required |
| 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. | Preferred |
| 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. | Preferred |
| Avanced knowledge of intellectual property principles, policies, regulations, practices and the technical and legal issues affecting the protection, use and exploitation of intellectual property. | Preferred |
| Advanced ability to identify complex problems and implement appropriate solutions. | Preferred |
| Advanced ability to develop and maintain effective working relationships within a diverse, multicultural, environment. | Preferred |
Special Requirements & Conditions
| Special Condition | Requirement |
|---|
Other Special Requirements & Conditions
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Level of Supervision Received
| GeneralDirection |
Environment
Working Environment
| Campus |
Other Requirements
Items Used
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Physical Requirements
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Mental Requirements
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Environmental Requirements
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Critical Position
| Is Critical Position: No |