Protocol Development Officer

Job Summary The Protocol Development Officer is a health professional who possesses in depth knowledge of FDA, GCP, and NIH guidelines and the ability to interpret and apply IRB policies and procedures to the development of new protocols in the Department of Radiology and Radiation oncology. This position is responsible for the management of Investigator Initiated Trials (IITs) from concept development through activation as well as the implementation and activation of industry sponsored projects. The Protocol Development Officer serves as the technical expert to ensure that trials are developed in accordance with FDA guidelines. The incumbent must have excellent communication and strong analytic skills as well as a willingness to cooperate as a team member. Also required is the use of advanced-level knowledge and skills to independently coordinate, direct and follow through in the overall administration and outcome of one or more protocols. Occasional travel (between UC Davis Health and the Explorer Molecular Imaging Center (EMIC) as well as overtime will be required. Apply By Date 8/24/2026 by 11:59pm Minimum Qualifications For full consideration, applicants are encouraged to upload license and/or certification if required of the position Society of Clinical Research Associates (SoCRA or the Association of Clinical Research Professionals ACRP) is required. Bachelor's degree in a related field and/or a combination of experience, education and/or training required. Minimum of 5-7 years of clinical research experience. Minimum of 5 years of experience with protocol development from initial concept through study activation. Advanced knowledge of FDA/GCP/NIH guidelines and the ability to interpret regulatory changes. Advanced knowledge of IRB policies and procedures. Extensive knowledge of clinical research regulations (FDA and OHRP). Advanced knowledge of medical terminology and basic anatomy. Demonstrate excellent organizational, interpersonal and communication skills, attention to detail, as well as the ability to take initiative and ownership of projects. Ability to work independently as well as part of a team. Working knowledge of Microsoft Office and databases associated with clinical research. Analytical skills to evaluate information, policies and procedures, formulate logical and objective conclusions and make recommendations for effective solutions. Ability to set priorities while assigned to multiple projects at a time, and to be flexible when there are changes in workload, pressures or deadlines, competing requirements and programmatic changes. Leadership skills to serve as a mentor/role model for less experienced and lower-level CRCs, if needed. Ability to work cooperatively as a team member in a diverse workforce. Ability to manage all aspects of INDs and RDRC documentation. Preferred Qualifications Master's degree in Business or Healthcare field is preferred. Minimum 2-3 years of UC Davis or UC experience preferred. Key Responsibilities 85% - Protocol Development 10% - Quality Assurance 5% - Professional Development/Training Department Overview The Department of Radiology is a large academic and clinical department within the School of Medicine which is responsible for teaching and training of residents, medical students, and clinical fellows, as well as both basic and creative clinical scholarly investigations. Radiology maintains a substantial amount of research, both basic and clinical trials, and provides services for interdepartmental research studies. Position Information Location: Davis Full/Part Time: Full Time Salary or Pay Range: $3,439.66 - $6,328.16 Salary Frequency: Bi-weekly Salary Grade: 137 UC Job Title: RSCH CMPLNC ANL 4 RP UC Job Code: 005270 Number of Positions: 1 Appointment Type: Staff: Career Percentage of Time: 100% Shift (Work Schedule): Monday - Friday, 8 hours Location: Ellison Ambulatory Care Center (HSP098) Union Representation: RP - Research and Public Service Professionals Benefits Eligible: Yes Work Location: This position is 100% on-site Benefits Outstanding benefits and perks are among the many rewards of working for the University of California. UC Davis offers a full range of benefits, resources and programs to help you bring your best self to work, as well as to help you and your family achieve your health, wellness, financial and career goals. Learn more about the benefits below and eligibility by visiting UCnet Benefits Page or Benefits Summary for UC Davis Health Employees or Benefits Summary for UC Davis Employees. High quality and low-cost medical plans to choose from to fit your family's needs UC pays for dental and vision coverage for you and your family Retirement plans for eligible employees including Pension and other Retirement Saving Plans Supplemental insurance offered including additional life, short/long term disability, pet insurance, legal coverage, accident, critical illness and hospital indemnity Pregnancy and Parental Leave, Family & Medical Leave, Adoption Assistance and Pay for Family Care and Bonding for eligible employees Lactation Support Program and Family Care discounts and resources Employee Well-being resources and programming to support thriving in all aspects of employee's lives On-site Employee Assistance Program including access to free mental health services Generous amount of paid Holidays annually as outlined in the UC Policies or Collective Bargaining Agreements Paid Time Off/Vacation/Sick Time as outlined in the UC Policies or Collective Bargaining Agreements Continuing Education (CE) allowance and Staff Education Reimbursement Program for eligible employees Access to free professional development courses and learning opportunities for personal and professional growth Public Service Loan Forgiveness (PSLF) Qualified Employer and Student Loan Debt Counseling Program for eligible employees Physical Demands Lifting/Carrying 0-25 Lbs - Occasional Up to 3 Hours Pushing/Pulling 0-25 Lbs - Occasional Up to 3 Hours Pushing/Pulling over 50 lbs - Occasional Up to 3 Hours Mental Demands Sustained attention and concentration - Continuous 6 to 8+ Hours Complex problem solving/reasoning - Continuous 6 to 8+ Hours Ability to organize & prioritize - Continuous 6 to 8+ Hours Communication skills - Frequent 3 to 6 Hours Numerical skills - Frequent 3 to 6 Hours Constant Interaction - Frequent 3 to 6 Hours Customer/Patient Contact - Frequent 3 to 6 Hours Multiple Concurrent Tasks - Continuous 6 to 8+ Hours Work Environment UC Davis is a smoke and tobacco free campus effective January 1, 2014. Smoking, the use of smokeless tobacco products, and the use of unregulated nicotine products (e-cigarettes) will be strictly prohibited on any UC Davis owned or leased property, indoors and outdoors, including parking lots and residential space. The incumbent must have the communication skills to convey factual information; to engage in collaborative problem-solving and negotiation with faculty, staff, and colleagues and serve as a role model, including demonstrating service excellence and upholding the university's Principles of Community. Required to work occasional overtime to meet work demands. Required to travel on occasion to and from UCD Health and EMIC sites. Special Requirements Please contact your recruiter with questions regarding which activities apply by position This is a critical position, as defined by UC Policy and local procedures, and as such, employment is contingent upon clearing a criminal background check(s) and may include drug screening, medical evaluation clearance and functional capacity assessment This position is designated as a mandated reporter under CANRA and UC policy, and employment is contingent on compliance with applicable policies, procedures and training requirements Misconduct Disclosure Requirement As a condition of employment, the final candidate who accepts a conditional offer of employment will be required to disclose if they have been subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct; received notice of any allegations or are currently the subject of any administrative or disciplinary proceedings involving misconduct; have left a position after receiving notice of allegations or while under investigation in an administrative or disciplinary proceeding involving misconduct; or have filed an appeal of a finding of misconduct with a previous employer. A Culture of Opportunity and Belonging At UC Davis, we're committed to solving life's most urgent challenges and building a healthier, more resilient world. We believe in growing through every challenge, continually striving to improve, and welcoming new perspectives that strengthen our community. We recognize that a vibrant and innovative organization values both individual strengths and shared purpose. The best ideas often emerge when people with different experiences come together. As you consider joining UC Davis, we invite you to explore our Principles of Community, our Clinical Strategic Plan and strategic vision for research and education. We believe you belong here. The University of California, Davis is an Equal Opportunity Employer. All qualified applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age or protected veteran status. To view the University of California's Anti-Discrimination Policy, please visit: Because we want you to feel seen and valued, our recruitment process at UC Davis supports openness and authenticity. Research shows that some individuals hesitate to apply unless they meet every qualification. You may be an excellent fit for this role-or the next one. We encourage you to apply even if your experience doesn't match every listed requirement. #YouBelongHere To learn more about our background check program, please visit: #J-18808-Ljbffr University of California - Davis