General Information
| Job Description | RSCH CMPLNC ANL 2 | Working Title | Research Compliance Analyst |
|---|---|---|---|
| Job Code | 006229 | Grade | 20 |
| Department Name | Research Compliance - D01234 | Department Head | Charles Greer |
| Supervisor | Lorraine Joy Castro | Effective Date | 09/12/2022 |
Position(s) Directly Supervised
| Job Code | Title | FTE |
|---|
Generic Scope
| Professional who applies acquired job skills, policies, and procedures to complete substantive assignments/projects/tasks of moderate scope and complexity; exercises judgment within defined guidelines and practices to determine appropriate action. |
Custom Scope
| Using research compliance concepts, applies organization policies and procedures to review and/or pre-review moderately complex, minimal risk research protocols. Works independently in most cases without a great deal of supervision or oversight for routine or standard assignments. Occasionally pre-reviews or highlights potential issues of concern for department head or committee members to consider in their review of research protocols that qualify for full review. |
Department Custom Scope
| UCR's Office of Research Integrity (ORI) promotes the highest standards of research excellence and ensures compliance with federal and state regulations. This position is responsible for providing support and leadership to various research compliance areas covered by the ORI. The Research Compliance Analyst will be responsible for providing support and leadership to the Institutional Review Boards (IRBs) as well as providing back up support, as needed, to the other compliance committees [Conflict of Interest (COI), Institutional Animal Care and Use Committee (IACUC), Stem Cell Research Oversight (SCRO) and Dual Use Research of Concern (DURC)]. The Research Compliance Analyst will serve as a resource to faculty and ensure that federal and state laws, as well as UC policy, are applied correctly. The Research Compliance Analyst will work closely with faculty to facilitate the ethical conduct of research. This position also interacts with a variety of campus and system-wide offices to facilitate the management, administration and conduct of research. |
Education & Experience Requirements
Education Requirements
| Degree | Requirement |
|---|---|
| Bachelor's degree in related area and/or equivalent experience/training. | Required |
| Advanced degree in related area. | Preferred |
Experience Requirements
| Experience | Requirement |
|---|---|
| 2 - 4 years of related experience. | Required |
| Professional experience in a higher education environment. | Preferred |
| Experience working with research administration. | Required |
| Professional experience in a compliance or research environment. | Preferred |
License Requirements
Certification Requirements
| Certification | Requirement |
|---|---|
| Relevant compliance certification (if applicable). | Preferred |
Educational Condition Requirements
| Condition | Requirement |
|---|
Key Responsibilities
| Description | % Time |
|---|---|
| Provides committee support including meeting coordination, maintenance of committee records, coordination of review process, tracking of required updates and renewals, and database management. | 20 |
| Applies research compliance professional concepts to review research protocols to ensure that all regulatory criteria are met as well as policies and/or regulations from the organization, the state and systemwide. | 15 |
| Working with others in the office, provides administrative support and leadership for the Institutional Review Boards (IRBs). When needed, may provide administrative support to other research compliance committees such as the Conflict of Interest (COI), Institutional Animal Care and Use Committee (IACUC), Stem Cell Research Oversight (SCRO) and Dual Research of Concern (DURC). | 15 |
| Under general supervision, participates in pre-review and follow-up of full board committee protocols. | 10 |
Communicates directly with investigators to resolve all concerns as identified during the review process.
|
10 |
| Communicates with researchers and provides guidance on how to resolve particular issues of concern and meet requirements of external regulatory bodies and to properly document these actions in accordance with all applicable laws, regulations, policies and procedures. | 10 |
| Participates in training of individuals and departments on relevant compliance process, forms and policies. | 10 |
| Under general supervision, issues formal communications to funding agencies and other regulatory organization units. | 5 |
| Participates in the development and revision of standard operating procedures and guidelines. | 5 |
Knowledge, Skills & Abilities
| Knowledge/Skill/Ability | Requirement |
|---|---|
| Knowledge of relevant Federal and State regulations, and policies. | Required |
| Strong organizational skills, the ability to multi-task, and work with frequent interruptions. | Required |
| Ability to problem solve issues; listen, interpret and confirm understanding of others' communications; and be objective. | Required |
| Independence, planning and decision making abilities to complete assigned duties. | Required |
| Excellent customer service skills, pleasant, helpful and patient. | Required |
| Proficiency with computers, including ability to operate personal computer software with sophisticated retrieval, storage, and merging capabilities. | Required |
| Effective, efficient and tactful oral and written communication skills. | Required |
| Ability to work in a team oriented setting, to prioritize work, and to follow through on routine assignments with minimal direction. | Required |
| Time management skills and the flexibility to accommodate changing priorities in unit. | Required |
| Demonstrated self-discipline and sound, independent judgment completing complex assignments. | Required |
| Ability to work in high-volume, high-pressure and fast-paced environment to manage and prioritize a large task list with deadlines, frequent interruptions and completing priorities. | Required |
| Detailed knowledge of substantial body of regulatory information regarding the protection of rights and welfare of human research participants (DHHS, OHRP, FDA, HIPPA). | Preferred |
| Ability to exercise good judgement in assessing risk level and contacting appropriate delegate during the review of research | Preferred |
| Thorough knowledge of compliance research regulations and guidance | Preferred |
Special Requirements & Conditions
| Special Condition | Requirement |
|---|
Other Special Requirements & Conditions
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Level of Supervision Received
| Supervision |
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: Yes |