Research Compliance Analyst 1-5 RP

Job Summary

Involves staffing, administering or managing research oversight and compliance committee activities related to research activities such as human subjects, animal use and care, conflict of interest and export control. Reviews research protocols for use in specific fields, assists in writing and reviewing protocols, and compliance with federal, state, and University mandated laws, regulations and policies.

Job Title	Research Compliance Analyst 1 RP	Research Compliance Analyst 2 RP	Research Compliance Analyst 3 RP	Research Compliance Analyst 4 RP	Research Compliance Analyst 5 RP
Job Code	5267	5268	5269	5270	5271
Bargaining Unit	RP	RP	RP	RP	RP
FLSA	Non-Exempt	Non-Exempt	Exempt	Exempt	Exempt
Generic Scope	Entry-level professional with limited prior experience; learns to use professional concepts to resolve problems of limited scope and complexity; works on assignments that are initially routine in nature, requiring limited judgment and decision making. Employees at this level are expected to acquire the skills and knowledge to perform more advanced work following an agreed upon time in position, through defined training and development planning.	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.	Experienced professional who knows how to apply theory and put it into practice with in-depth understanding of the professional field; independently performs the full range of responsibilities within the function; possesses broad job knowledge; analyzes problems / issues of diverse scope and determines solutions.	Technical leader with a high degree of knowledge in the overall field and recognized expertise in specific areas; problem-solving frequently requires analysis of unique issues / problems without precedent and / or structure. May manage programs that include formulating strategies and administering policies, processes, and resources; functions with a high degree of autonomy.	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. Directs programs with organization-wide impact (or may have impact beyond the University) that include formulating strategies and administering policies, processes, and resources. Significant barriers to entry exist at this level.
Custom Scope	Uses research compliance professional concepts to support protocol submission process. Reviews and / or pre-reviews minimal risk, expedited or standard procedure research protocols. Applies defined policies and procedures to categorize or analyze departmental issues. This title is bargaining unit only. There should never be an uncovered position.	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 heads or committee members to consider in their review of research protocols that qualify for full review. Typically, the bargaining unit job code should be used for work covered by this title. However, if the position is not covered by the Higher Education Employer-Employee Relations Act (HEERA) due to one of the following reasons—(1) Confidential status, where duties normally require access to confidential information that significantly influences the development of management’s bargaining or grievance positions; (2) employed outside of California at a location with 100 or fewer employees; or (3) Supervisory status, where duties include supervising employees as a regular part of the job—then the position should be listed under the generic title without the “RP” ending.	Uses skills as a seasoned, experienced research compliance professional with a full understanding of industry practices and organization policies / procedures to apply federal, state, and university regulations, policies, and guidelines, and promote best practices. Interacts frequently with investigators, persons in other organizational departments, and occasionally persons outside the University. Interactions require the use of tact and independent judgment, knowledge of standards and best practices, and counseling to resolve a wide range of research compliance issues. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Errors or omissions may ultimately place research participant at undo risk and / or compromise the institution’s assurance of regulatory compliance with the federal government. Typically, the bargaining unit job code should be used for work covered by this title. However, if the position is not covered by the Higher Education Employer-Employee Relations Act (HEERA) due to one of the following reasons—(1) Confidential status, where duties normally require access to confidential information that significantly influences the development of management’s bargaining or grievance positions; (2) employed outside of California at a location with 100 or fewer employees; or (3) Supervisory status, where duties include supervising employees as a regular part of the job—then the position should be listed under the generic title without the “RP” ending.	Uses advanced research compliance concepts to interpret highly complex and broad regulations, policies and guidelines. Regularly works on highly complex research compliance issues where analysis requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria to anticipate and identify problems and develop and implement the appropriate response and / or action. Serves as a technical expert and advisor to department head. Typically, the bargaining unit job code should be used for work covered by this title. However, if the position is not covered by the Higher Education Employer-Employee Relations Act (HEERA) due to one of the following reasons—(1) Confidential status, where duties normally require access to confidential information that significantly influences the development of management’s bargaining or grievance positions; (2) employed outside of California at a location with 100 or fewer employees; or (3) Supervisory status, where duties include supervising employees as a regular part of the job—then the position should be listed under the generic title without the “RP” ending.	Having wide-ranging experience, uses research compliance concepts and organization objectives to resolve the most complex issues having organization-wide impact. Works on the most complex issues where little or no organization precedent exists and analysis of situation(s) or data require an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results. Internal and external contacts often pertain to organization plans and objectives. Is considered a subject matter expert in the organization and often recognized as an expert externally in the industry. Typically, the bargaining unit job code should be used for work covered by this title. However, if the position is not covered by the Higher Education Employer-Employee Relations Act (HEERA) due to one of the following reasons—(1) Confidential status, where duties normally require access to confidential information that significantly influences the development of management’s bargaining or grievance positions; (2) employed outside of California at a location with 100 or fewer employees; or (3) Supervisory status, where duties include supervising employees as a regular part of the job—then the position should be listed under the generic title without the “RP” ending.
Key Resp 01	Under direct supervision, reviews basic research protocols to ensure that all regulatory criteria are met.	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.	Reviews complex research protocols when applying federal regulations, state regulations, and University policies to ensure and document compliance.	Applies advanced research compliance concepts to interpret and apply a wide variety of highly complex policies, regulations and guidelines governing research compliance, and / or disclosures.	Serves as technical / analytical expert / advisor to director, faculty, national and systemwide committees and professional organizations.
Key Resp 02	Participates as directed by senior staff in pre-review and follow-up of full board protocols.	Under general supervision, participates in pre-review and follow-up of full board committee protocols.	Provides guidance on preparing and revising research applications.	Advises faculty on research compliance, funding and other highly complex issues for research projects.	Advises faculty planning large, multi-faceted or complex research projects on relevant research compliance issues and coordinates with other units and / or outside organizations.
Key Resp 03	Determines and evaluates the appropriate level of review in triage.	Determines the appropriate level of review in triage.	Determines appropriate level of review.	May lead a team of research compliance professionals.	Participates in national boards.
Key Resp 04	Under direct supervision, drafts formal communications to funding agencies and other regulatory organization units for review and approval by senior staff member.	Under general supervision, issues formal communications to funding agencies and other regulatory organization units.	Applies research compliance professional concepts to review and pre-review complex research protocols, as well as documentation of research.	Initiates and designs the development and revision of operating procedures, policies, and guidelines.	Reviews, analyzes and classifies all disclosures for research gifts, proposals, grants, contracts and research.
Key Resp 05	Generates reports of review and approval activities, coordinates committee meetings, and records and drafts the minutes of meetings.	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.	Communicates with researchers and provides guidance on how to resolve particular issues and meet requirements of external regulatory bodies, and properly documents these actions in accordance with all applicable laws, regulations, policies, and procedures.	Communicates with researchers and provides guidance on how to resolve particularly complex issues and meet requirements of external regulatory bodies. Ensures that all actions are properly documented in accordance with all applicable laws, regulations, policies, and procedures.	Independently develops responses and / or comments on behalf of organization on proposed federal or state regulations.
Key Resp 06	Categorizes and analyzes conflict of interest disclosures.	Generates and analyzes reports of review and approval activities.	Classifies and analyzes disclosures related to conflict of interest.	Classifies and analyzes disclosures related to highly complex conflict of interest issues.	Interacts with federal government for review, recordkeeping and adherence to published regulations.
Key Resp 07	Participates in the development and revision of standard operating procedures and guidelines.	Communicates directly with investigators to resolve all concerns as identified during the review process.	Understands and coordinates complex disclosure cases where multiple policies can impact a single project.	Independently reviews and analyzes export control activities.	Independently reviews and analyzes export control activities. Obtains government approvals such as licenses or registrations.
Key Resp 08	Maintains departmental database.	Participates in training of individuals and departments on relevant compliance processes, forms and policies.	Trains individuals and departments on relevant compliance processes, forms and policies.	Helps develop materials and conducts training for departments on relevant compliance issues, processes, forms, and policies. Provides education and training through the development and delivery of in person training, online educational materials, printed materials, and other web-based resources.	Regularly develops or oversees development of specialized training for departments and individuals.
Key Resp 09		Participates in the development and revision of standard operating procedures and guidelines.			Drafts and / or proposes new organization-wide policies and procedures for department based on analysis of issues facing organization oversight committees, institution and national groups. Applies advanced research compliance concepts, interprets and applies a wide variety of highly complex policies, regulations and guidelines governing research compliance and disclosures.
Education	Bachelor’s degree in related area and / or equivalent experience / training.	Bachelor’s degree in related area and / or equivalent experience / training.	Bachelor’s degree in related area and / or equivalent experience / training.	Bachelor’s degree in related area and / or equivalent experience / training.	Bachelor’s degree in related area and / or equivalent experience / training.
Certification		Relevant compliance certification (if applicable) preferred.	Relevant compliance certification (if applicable) preferred.	Relevant compliance certification (if applicable) preferred.	Relevant compliance certification (if applicable) preferred.
Special Condition	Exercise the utmost discretion in managing sensitive information learned in the course of performing their duties. Sensitive information includes but is not limited to employee and student records, health and patient records, financial data, strategic plans, proprietary information, and any other sensitive or non-public information learned during the course and scope of employment. Understands that sensitive information should be shared on a limited basis and actively takes steps to limit access to sensitive information to individuals who have legitimate business need to know. Ensure that sensitive information is properly safeguarded. Follow all organizational policies and laws on data protection and privacy. This includes secure handling of physical and digital records and proper usage of IT systems to prevent data leaks. The unauthorized or improper disclosure of confidential work-related information obtained from any source on any work-related matter is a violation of these expectations.	Exercise the utmost discretion in managing sensitive information learned in the course of performing their duties. Sensitive information includes but is not limited to employee and student records, health and patient records, financial data, strategic plans, proprietary information, and any other sensitive or non-public information learned during the course and scope of employment. Understands that sensitive information should be shared on a limited basis and actively takes steps to limit access to sensitive information to individuals who have legitimate business need to know. Ensure that sensitive information is properly safeguarded. Follow all organizational policies and laws on data protection and privacy. This includes secure handling of physical and digital records and proper usage of IT systems to prevent data leaks. The unauthorized or improper disclosure of confidential work-related information obtained from any source on any work-related matter is a violation of these expectations.	Exercise the utmost discretion in managing sensitive information learned in the course of performing their duties. Sensitive information includes but is not limited to employee and student records, health and patient records, financial data, strategic plans, proprietary information, and any other sensitive or non-public information learned during the course and scope of employment. Understands that sensitive information should be shared on a limited basis and actively takes steps to limit access to sensitive information to individuals who have legitimate business need to know. Ensure that sensitive information is properly safeguarded. Follow all organizational policies and laws on data protection and privacy. This includes secure handling of physical and digital records and proper usage of IT systems to prevent data leaks. The unauthorized or improper disclosure of confidential work-related information obtained from any source on any work-related matter is a violation of these expectations.	Exercise the utmost discretion in managing sensitive information learned in the course of performing their duties. Sensitive information includes but is not limited to employee and student records, health and patient records, financial data, strategic plans, proprietary information, and any other sensitive or non-public information learned during the course and scope of employment. Understands that sensitive information should be shared on a limited basis and actively takes steps to limit access to sensitive information to individuals who have legitimate business need to know. Ensure that sensitive information is properly safeguarded. Follow all organizational policies and laws on data protection and privacy. This includes secure handling of physical and digital records and proper usage of IT systems to prevent data leaks. The unauthorized or improper disclosure of confidential work-related information obtained from any source on any work-related matter is a violation of these expectations.	Exercise the utmost discretion in managing sensitive information learned in the course of performing their duties. Sensitive information includes but is not limited to employee and student records, health and patient records, financial data, strategic plans, proprietary information, and any other sensitive or non-public information learned during the course and scope of employment. Understands that sensitive information should be shared on a limited basis and actively takes steps to limit access to sensitive information to individuals who have legitimate business need to know. Ensure that sensitive information is properly safeguarded. Follow all organizational policies and laws on data protection and privacy. This includes secure handling of physical and digital records and proper usage of IT systems to prevent data leaks. The unauthorized or improper disclosure of confidential work-related information obtained from any source on any work-related matter is a violation of these expectations.
KSA 01	Human subjects, and animal care and use: academic training in the biological or social sciences, humanities or bioethics.	Independence, planning and decision-making abilities to complete assigned duties.	Demonstrated self-discipline and sound, independent judgment completing complex assignments.	Demonstrated self-discipline and independent judgment completing highly complex, broadly defined assignments.	Demonstrated self-discipline and independent judgment completing highly complex, broadly defined assignments.
KSA 02	Attention to detail.	Knowledge of relevant Federal and State regulations, and policies.	Thorough knowledge and ability to apply all relevant Federal, state, and university regulations, policies, and federal guidance documents.	Advanced knowledge and ability to apply all relevant Federal, state, and university regulations policies, and federal guidance documents.	Expert knowledge and ability to apply all of the Federal, state, system and university regulations, policies and federal guidance documents.
KSA 03	Ability to read and comprehend complex materials.	Ability to solve problems, issues; listen, interpret and confirm understanding of others’ communications; and be objective.	Thorough knowledge and experience with quantitative and qualitative research design; scientific research concepts and terminology.	Advanced knowledge of quantitative and qualitative research design, scientific research concepts and terminology.	Expert knowledge of quantitative and qualitative research design, scientific research concepts, and terminology.
KSA 04	Excellent writing and oral communication skills (clarity, sentence / paragraph construction and grammar, et cetera).	Effective, efficient and tactful oral and written communication skills.	Demonstrated proficiency in public speaking, and writing.	Strong proficiency in public speaking, and writing.	Advanced proficiency in public speaking, and writing.
KSA 05	Demonstrated ability and desire to learn; curiosity around the research activities in which they are involved.	Time management skills and the flexibility to accommodate changing priorities in unit.	Understanding of stock options, consulting agreements and other corporate documents related to research and analysis of potential conflicts of interest.	Advanced understanding of stock options, consulting agreements and other corporate documents related to research and analysis of potential conflicts of interest.	Ability to resolve conflicts on a timely basis.
KSA 06	Skills in problem solving, multi-tasking, working with frequent interruptions, and is an effective listener.	Ability to work in a team-oriented setting, to prioritize work, and to follow through on routine assignments with minimal direction.			Ability to interact with faculty with professionalism and decorum.
KSA 07	Proficiency with office equipment and knowledge of standard office software.	Proficiency with computers, including the ability to operate personal computer software with sophisticated retrieval, storage, and merging capabilities.			Ability to lead and mentor others.
KSA 08	Basic knowledge of relevant federal, state, organizational and system policies.	Excellent customer service skills, pleasant, helpful and patient.
KSA 09	Familiarity with internet searching.	Strong organizational skills, the ability to multi-task, and work with frequent interruptions.
Environment	Campus, medical center or other university setting and various external venues.	Campus, medical center or other university setting and various external venues.	Campus, medical center or other university setting and various external venues.	Campus, medical center or other university setting and various external venues.	Campus, medical center or other university setting and various external venues.