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Job Function Summary: Involves the development of and ensures compliance with clinical study protocols that involve human subjects. Oversees and resolves operational aspects of clinical studies or trials in conjunction with project teams and in accordance with standard operating procedures and good clinical practice and regulations. May be responsible for finances, clinical operations, and site and vendor selection. Generic Scope Spends the majority of time (50% or more) achieving organizational objectives through the coordinated achievements of subordinate staff. Establishes departmental goals and objectives, functions with autonomy. Manages the accountability and stewardship of human, financial, and often physical resources in compliance with departmental and organizational goals and objectives. Ensures subordinate supervisors and professionals adhere to defined internal controls. Manages systems and procedures to protect departmental assets. Custom Scope The Director of Research Operations (DRO) serves in a critical leadership role within the Immune Tolerance Network (ITN). Drawing on deep expertise in clinical research operations, the DRO leads the execution of complex, multicenter clinical trials in the autoimmune therapeutic area, ensuring compliance with applicable regulations, guidelines, and best practices. The DRO oversees operational staff supporting trial management and provides strategic leadership to advance ITN operational initiatives and long-term organizational goals.
| % of time |
Essential Function (Yes/No) |
Key Responsibilities (To be completed by Supervisor) |
| 5 |
Yes |
Develops, manages and oversees the organizational, strategic and tactical aspects of a clinical trial program |
| 20 |
Yes |
Provides operational, clinical and project management oversight for assigned research |
| 10 |
Yes |
Translates clinical research objectives, policies and procedures into an operational plan |
| 10 |
Yes |
Establishes clinical research goals to ensure trial achieves pre-defined sponsor goals, study coordinating center goals and departmental objectives |
| 2 |
Yes |
Develops ways to measure research productivity and quality |
| 2 |
Yes |
Follows operational processes in selecting methods and techniques for trials |
| 2 |
Yes |
Analyzes and reports success of research and suggests improvements |
| 2 |
Yes |
Designs and implements quality control processes for research programs, including regular program evaluations to meet department standards |
| 10 |
Yes |
Ensures study research personnel collect data and perform study assessments in a standardized fashion consistent with the study protocol Manages program resources of assigned studies |
| 1 |
Yes |
Manages systems and processes designed to ensure successful revenue collection, invoicing and reimbursement accounting |
| 1 |
Yes |
Develops strategic plans for ensuring high-quality interactions with the ethical review boards, investigators, regulatory authorities, and vendors, leading to successful execution of clinical development plans and submissions for the trial |
| 5 |
Yes |
Works collaboratively with Principal Investigator, internal and external partners and vendors |
| 2 |
Yes |
Manages integral committees to the study |
| 2 |
Yes |
Represents the trial to study committees, partners, corporate / industry partners, regulatory and oversight agencies and the public as necessary |
| 1 |
No |
Publishes research findings |
| 2 |
No |
Determines salary actions, promotions and terminations |
| 5 |
Yes |
Conducts necessary personnel actions for assigned staff including disciplinary actions |
| 2 |
Yes |
Proposes changes in staffing as needed |
| 2 |
Yes |
Executes recruiting, hiring and onboarding, ensuring that new hires meet standards |
| 2 |
Yes |
Implements and administers employee evaluations that meet organization standards |
| 2 |
Yes |
Evaluates assigned staff and defines development goals |
| 5 |
Yes |
Promotes professional growth and advancement for staff |
| 5 |
Yes |
Trains study team and provide certifications for the study |
Required Qualifications
- Bachelor's degree in related area and 10+ years experience in clinical research, or equivalent combination of education and experience.
- Clinical research (CCRP, CCRC, CCRA) Certification
- Prior lead/supervisory experience
- Broad academic knowledge and applied background in clinical research philosophy
- Applies knowledge of theoretical concepts and business best practices in a trial setting
- Proven ability to translate clinical research philosophy into direct and indirect clinical input to design, planning, initiation, execution and reporting of clinical trials
- Broad knowledge of clinical research concepts, federal, state and local laws and regulations, and industry requirements regarding the proper conduct of clinical trials
- Broad theoretical and operational knowledge of clinical and patient safety standards and regulations relating to clinical research
- Broad knowledge of all phases of clinical research, from study startup through closeout and primary publication and presentation
- Knowledgeable about clinical studies involving complex trial design issues
- Demonstrated management skills supervising, maintaining and developing clinical staff within the study team, and acting as a mentor for professional staff and conducting reviews and performance evaluations
- Effectively manages multiple important priorities
- Demonstrated ability to work collaboratively with other cross-functional teams and people with a wide range of educational backgrounds
- Demonstrated ability to interface with commercial, regulatory, federal and other members of an extended study team
- Ability to influence / persuade
- Demonstrates excellent problem-solving and analytical skills
- Creatively addresses complex or new problems
- Proven skills to quickly evaluate complex issues and identify multiple options for resolution
- Strong communicator; includes verbal and written, active listening, critical thinking, persuasiveness, advising and counseling skills
- Skill in analyzing and presenting data and strategy to relevant team, governance, external consultant, and regulatory / oversight meetings
- Demonstrated ability to organize research work functions in an efficient and effective manner
- Great organizational skills applied to personal work and improving organization of assigned staff and trial
- Technical proficiency in project management software
Preferred Qualifications
- Expert user of the campus' clinical information and documentation application programs
- Master's degree in related area and more than 8+ years' experience in clinical research, or equivalent combination of education and experience.
Required Qualifications
- Bachelor's degree in related area and 10+ years experience in clinical research, or equivalent combination of education and experience.
- Clinical research (CCRP, CCRC, CCRA) Certification
- Prior lead/supervisory experience
- Broad academic knowledge and applied background in clinical research philosophy
- Applies knowledge of theoretical concepts and business best practices in a trial setting
- Proven ability to translate clinical research philosophy into direct and indirect clinical input to design, planning, initiation, execution and reporting of clinical trials
- Broad knowledge of clinical research concepts, federal, state and local laws and regulations, and industry requirements regarding the proper conduct of clinical trials
- Broad theoretical and operational knowledge of clinical and patient safety standards and regulations relating to clinical research
- Broad knowledge of all phases of clinical research, from study startup through closeout and primary publication and presentation
- Knowledgeable about clinical studies involving complex trial design issues
- Demonstrated management skills supervising, maintaining and developing clinical staff within the study team, and acting as a mentor for professional staff and conducting reviews and performance evaluations
- Effectively manages multiple important priorities
- Demonstrated ability to work collaboratively with other cross-functional teams and people with a wide range of educational backgrounds
- Demonstrated ability to interface with commercial, regulatory, federal and other members of an extended study team
- Ability to influence / persuade
- Demonstrates excellent problem-solving and analytical skills
- Creatively addresses complex or new problems
- Proven skills to quickly evaluate complex issues and identify multiple options for resolution
- Strong communicator; includes verbal and written, active listening, critical thinking, persuasiveness, advising and counseling skills
- Skill in analyzing and presenting data and strategy to relevant team, governance, external consultant, and regulatory / oversight meetings
- Demonstrated ability to organize research work functions in an efficient and effective manner
- Great organizational skills applied to personal work and improving organization of assigned staff and trial
- Technical proficiency in project management software
Preferred Qualifications
- Expert user of the campus' clinical information and documentation application programs
- Master's degree in related area and more than 8+ years' experience in clinical research, or equivalent combination of education and experience.
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University of California - San Francisco
180723
May 22, 2026