Assistant Clinical Research Coordinator

University of California - Davis; California, Sacramento (MO, CA); Hybrid; USD 80,000 - 100,000; Full time

Job summary

The University of California, Davis is seeking an Assistant Regulatory Research Coordinator to support cancer research efforts by managing regulatory compliance for clinical protocols. This full-time position involves collaboration with various committees and requires strong analytical and communication skills. The role is hybrid, offering a mix of on-site and remote work.

Benefits

High quality and low-cost medical plans

Paid Time Off/Vacation/Sick Time

Continuing Education allowance

Access to free professional development courses

Public Service Loan Forgiveness Qualified Employer

Qualifications

• Minimum 1-year relevant experience required.
• Knowledge of clinical research regulations and institutional committees.

Responsibilities

• Regulatory coordination for cancer-related protocols.
• Manage submissions to various institutional research committees.

Skills

Analytical skills

Communication

Organizational skills

Interpersonal skills

Detail-oriented

Education

High School graduation or GED

Bachelor's Degree in related area

Tools

Microsoft Office Suite

Job description

Apply for Job

Job ID

78255

Location

Sacramento

Full/Part Time

Full Time

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Job Summary

Under the direct supervision of the Supervisor of the Regulatory Unit, the Assistant Regulatory Research Coordinator (ARRC) supports the clinical research efforts of the Cancer Center by providing comprehensive, regulatory management for low to medium complexity cancer-related protocols in accordance with human subject federal regulations, internal standard operating procedures (SOPs), and University policies and procedures.

Apply By Date: 5/22/2025 by 11:59pm

Minimum Qualifications - For full consideration, applicants are encouraged to upload license and/or certification if required of the position

• High School graduation or GED equivalent and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities.
• Minimum 1-year relevant experience.
• Knowledge of submitting to various institutional research committees, i.e., Institutional Review Board, Protocol Review Monitoring Committee, Data Safety Monitoring Board, Institutional Biosafety, Radiation Safety Committee, and Epidemiology Infectious Prevention.
• Knowledge of clinical research regulations (e.g., Food and Drug Administration [FDA] and Office for Human Research Protections [OHRP]).
• Working knowledge with Microsoft Office Suite: Word, Excel, Outlook, Access, etc.
• Tracking and recordkeeping experience or skills.
• Analytical skills to evaluate information, changes in practices and procedures, formulate logical and objective conclusions
• Demonstrate oral communication and interpersonal skills to correspond effectively with the public, co-workers, physicians, patients, caregivers, clinic staff and other health care professionals.
• Display organizational skills and attention to detail so that large volumes of records can be accurately maintained to accomplish a task or goal in a timely manner.
• Ability to prioritize assignments and achieve high productivity/quality with short time frames, under rigid deadlines, and /or in environments with frequent workload changes and competing demands.
• Display writing skills including ability to compose reports and correspondence while utilizing correct grammar, spelling and punctuation as well as clearly documenting research data onto forms.
• Ability to work independently and/or cooperatively as a team member in a diverse workforce.
• Demonstrated experience in maintaining flexibility and adaptability while implementing institutional change.
• Ability to take initiative and demonstrate strong commitment to duties.
• Ability to work occasional overtime as work demands.
• Ability to travel on occasion.

Preferred Qualifications

• Bachelor's Degree in related area.
• Previous experience regulatory research experience.
• Previous experience working in a cancer center.

Key Responsibilities

• 60% - Regulatory Coordination
• 10% - Quality Assurance
• 15% - Data Management
• 15% - Essential Document Coordination and Record Retention

Department Overview

The UC Davis Comprehensive Cancer Center (UCDCCC) is a campus-wide multidisciplinary matrix organization whose mission is to reduce the burden of cancer among the diverse populations in our community and beyond through bidirectional engagement and transdisciplinary collaborations that enhance our understanding of cancer, inform new ways to prevent and treat cancer, and prepares a committed and inclusive workforce. The Office of Clinical Research (OCR) is the centralized office for clinical research operations within UCDCCC. The OCR services support the entire lifecycle of cancer-related clinical research protocols. These include support for development and implementation of clinical trials, quality control of clinical research operations, and training and education services.

Department Specific Job Scope

Responsibilities related to regulatory coordination activities include managing and preparing submissions of modifications, renewals, reportable new information, and study closures to the Institutional Review Board (IRB), Food and Drug Administration (FDA) and other ancillary committees including, but not limited to, Scientific Review Committee (SRC), Data and Safety Monitoring Committee (DSMC), Institutional Biosafety Committee (IBC), Radiation Use Committee (RUC), and Epidemiology Infectious Prevention (EIP). The ARRC is responsible for effectively shepherding protocols through the regulatory committee process in a timely manner to ensure the activation of trial and for all regulatory aspects of the protocols assigned.

In addition, the ARRC serves as the liaison to sponsors and governing agencies, and facilitates the transmission of verbal and written communication to National Clinical Trials Network (NCTN) groups, pharmaceutical companies, and other research entities as needed. The incumbent is also responsible for maintaining communication with all elements of a multi-level research network, including attending Disease Team (DT) meetings, interacting with sponsoring agencies including National Cancer Institute, and compliance and regulatory groups such as the Institutional Review Board (IRB), Food and Drug Administration (FDA), and sponsor monitors.

The incumbent must accurately maintain regulatory information in the clinical trial management systems (OnCore and Florence eBinders) and adhere to institutional policies and external Cancer Center Support Grant guidelines for reporting to the National Cancer Institute (NCI).

POSITION INFORMATION

• Salary or Pay Range: $29.02 - $46.72
• Salary Frequency: Hourly
• Salary Grade: 102
• UC Job Title: CLIN RSCH CRD AST
• UC Job Code: 009336
• Number of Positions: 1
• Appointment Type: Staff: Career
• Percentage of Time: 100%
• Shift (Work Schedule): Mon-Fri 8a - 5p
• Location: Facilities Support Srvcs Bldg (HSP068)
• Union Representation: Yes, RX-Research Professionals
• Benefits Eligible: Yes
• This position is hybrid (mix of on-site and remote work)
• This is not a H-1B Visa Opportunity

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 rules by visiting either our handy Benefits Summary for UC Davis Health Employees or Benefits Summary for UC Davis Employees and our Benefits Page.

If you are represented by a union, benefits are negotiated between the University of California (UC) and your union and finalized in a contract. Read your bargaining unit's employment contract, stay abreast of current negotiations and learn about collective bargaining at UC: https://ucnet.universityofcalifornia.edu/labor/bargaining-units/index.html

* High quality and low-cost medical plans to choose from to fit your family's needs
* UC pays for Dental and Vision insurance premiums for you and your family
* Extensive leave benefits including Pregnancy and Parental Leave, Family & Medical Leave
* Paid Holidays annually as stipulated in the UC Davis Health Policies or Collective Bargaining Agreement
* Paid Time Off/Vacation/Sick Time as stipulated in the UC Davis Health Policies or Collective Bargaining Agreement
* Continuing Education (CE) allowance and Education Reimbursement Program as stipulated in the UC Davis Health Policies or Collective Bargaining Agreement
* Access to free professional development courses and learning opportunities for personal and professional growth
* WorkLife and Wellness programs and resources
* On-site Employee Assistance Program including access to free mental health services
* Supplemental insurance offered including additional life, short/long term disability, pet insurance and legal coverage
* Public Service Loan Forgiveness (PSFL) Qualified Employer & Student Loan Repayment Assistance Program for qualified roles
* Retirement benefit options for eligible roles including Pension and other Retirement Saving Plans. More information on our retirement benefits can be found here

Physical Demands

• Standing - Frequent 3 to 6 Hours
• Walking - Frequent 3 to 6 Hours
• Sitting - Occasional Up to 3 Hours
• Lifting/Carrying 0-25 Lbs - Occasional Up to 3 Hours
• Lifting/Carrying 26-50 lbs - Occasional Up to 3 Hours
• Lifting/Carrying over 50 lbs - Occasional Up to 3 Hours
• Pushing/Pulling 0-25 Lbs - Occasional Up to 3 Hours
• Pushing/Pulling 26-50 lbs - Occasional Up to 3 Hours
• Pushing/Pulling over 50 lbs - Occasional Up to 3 Hours
• Bending/Stooping - Occasional Up to 3 Hours
• Squatting/Kneeling - Occasional Up to 3 Hours
• Twisting - Occasional Up to 3 Hours
• Climbing (e.g., stairs or ladders) - Occasional Up to 3 Hours
• Reaching overhead - Occasional Up to 3 Hours
• Keyboard use/repetitive motion - Occasional Up to 3 Hours

Environmental Demands

• Chemicals, dust, gases, or fumes - Frequent 3 to 6 Hours
• Loud noise levels - Continuous 6 to 8+ Hours
• Marked changes in humidity or temperature - Frequent 3 to 6 Hours
• Microwave/Radiation - Occasional Up to 3 Hours
• Operating motor vehicles and/or equipment - Frequent 3 to 6 Hours
• Extreme Temperatures - Occasional Up to 3 Hours
• Uneven Surfaces or Elevations - Frequent 3 to 6 Hours

Mental Demands

• Sustained attention and concentration - Continuous 6 to 8+ Hours
• Complex problem solving/reasoning - Frequent 3 to 6 Hours
• Ability to organize & prioritize - Continuous 6 to 8+ Hours
• Communication skills - Continuous 6 to 8+ Hours
• Numerical skills - Occasional Up to 3 Hours
• Constant Interaction - Frequent 3 to 6 Hours
• Customer/Patient Contact - Continuous 6 to 8+ Hours
• Multiple Concurrent Tasks - Occasional Up to 3 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.
• Ability to work occasional overtime as work demands.Ability to travel on occasion.

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: https://policy.ucop.edu/doc/1001004/Anti-Discrimination

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: https://hr.ucdavis.edu/departments/recruitment/ucd/selection/background-checks