Clinical Research Analyst 4 – 5 RP

Job Summary

Develops and ensures compliance with clinical study protocols involving human subjects. Manages and resolves operational aspects of clinical studies and trials in collaboration with project teams, adhering to standard operating procedures, Good Clinical Practice (GCP), and regulatory requirements. May be responsible for budgets, clinical operations, and the selection of sites and vendors.

Job Title	Clinical Research Analyst 4 RP	Clinical Research Analyst 5 RP
Job Code	5236	5237
Bargaining Unit	RP	RP
FLSA	Exempt	Exempt
Generic Scope	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	Applies extensive knowledge of clinical research protocols and processes to design research projects of large scope and high degrees of complexity. 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.	As a recognized research expert, applies comprehensive knowledge of clinical research protocols and processes to lead the most complex projects of critical impact. 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	Functions as a lead in development of new processes and protocols with project team for highly complex clinical trials. Oversees and manages protocol amendments.	Oversees development of process and protocols for highly complex clinical trials. Operationalizes clinical interventions and data collection for faculty initiated or sponsored research. Designs and implements new corrective actions, therapies and/or procedures arising from research analysis.
Key Resp 02	Monitors, evaluates and coordinates data from multiple systems to recommend new actions / procedures from research analysis. Participates in preparation of manuscripts, abstracts and scientific presentations.	Conducts clinical teaching, consultation and assistance with management of unusual findings or events. Prepares manuscripts, abstracts and scientific presentations.
Key Resp 03	Conducts large project feasibility assessments. Analyzes risks, strategies and solutions. Develops project timelines and key milestones for assigned projects. Recommends adjustments to budgets and vendor agreements as necessary.	Conducts multi-project feasibility assessments. Oversees project timelines and milestones. Evaluates and implements adjustments to budgets and vendor agreements as necessary.
Key Resp 04	Assesses policies and processes to ensure the proposed project plan is compliant with applicable guidelines. Revises research / trial documents so they are consistent with protocol revisions.	Applies expertise in trial subject area to ensure policies and processes reflect new discoveries, regulatory requirements and best practice methodologies. Regularly leads and guides management on research matters of significant impact. Monitors trial protocols and makes revisions as necessary.
Key Resp 05	As a technical lead, provides guidance to all levels of management on ways to improve effectiveness. Proactively recommends interventions / corrective actions to meet project goals.	As recognized expert, provides strategic guidance on performance / department improvement initiatives. Identifies areas for improvement and develops methods for assessing compliance, risk and increased effectiveness of research initiatives.
Key Resp 06	Ensures reporting is consistent with external guidelines, university policies and regulations.	Ensures reporting is consistent with external guidelines, university policies and regulations.
Key Resp 07	Functions as a lead with other team members. Provides direction and guidance to project team members.	Mentors and coaches other team members. Encourages development and continuing education opportunities to develop expertise in research areas.
Education	Bachelor’s degree in related area and / or equivalent experience / training.	Bachelor’s degree in related area and / or equivalent experience / training.
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.
KSA 01	Advanced knowledge of clinical research practices and philosophy, and ability to apply knowledge and skills to recommend improvements in methodology. Advanced knowledge of regulatory requirements.	Expert knowledge of clinical research practices and philosophy and expert ability to translate clinical research philosophy into business best practices in a trial setting. Expert knowledge of regulatory requirements.
KSA 02	Advanced ability to effectively lead one or more projects with competing to meet the demands of a fast-paced and dynamic work environment. Adaptable to quickly changing priorities.	Expert project management skills. Demonstrated adaptability and flexibility to lead multiple complex, high impact projects and teams. Anticipates and effectively handles change.
KSA 03	In depth critical thinking skills to evaluate issues and identify a potential solution. Creatively addresses complex or new problems.	Expert critical thinking skills to challenge conventional practices, adapt established methods for improved uses, pursue ongoing system improvement, create novel solutions to problems, and evaluate new concepts as potential solutions to existing problems.
KSA 04	Advanced communication skills; including verbal and written, active listening, critical thinking, persuasiveness, advising and counseling skills. Clear and concise communicator.	Highly developed communication skills; including verbal and written, active listening, critical thinking, persuasiveness, advising and counseling skills. Clear and concise communicator. Expert ability to influence and negotiate.
KSA 05	Advanced interpersonal skills, including but not limited to problem-solving, mentoring, team development and leadership. Collaborates to achieve goals.	Highly skilled interpersonal skills, including problem-solving, mentoring, team development and leadership. Ability to cultivate relationships with multiple stakeholders across the  organization. Collaborates to achieve goals.
KSA 06	Proven ability to utilize all applicable software applications for word processing and spreadsheet development. Advanced knowledge of clinical information and documentation applications. Proven ability utilizing clinical trial management systems.	Expert ability to utilize all applicable software applications. Expert knowledge of clinical information and documentation applications. Proven ability utilizing clinical trial management systems.
KSA 07	In depth ability to work collaboratively with cross-functional teams. In depth ability to interface, collaborate, influence and persuade members of an extended study team.	Expert ability to work collaboratively with cross-functional teams. In depth ability to interface, collaborate, influence and persuade members of an extended study team. Expert ability to effectively coordinate and integrate programs across divisions, departments, and the organization.
Environment	Health care (hospital, clinical, classroom setting or similar environment as the role requires)	Health care (hospital, clinical, classroom setting or similar environment as the role requires)