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Regulatory Senior Clinical Research Coordinator
Regulatory Senior Clinical Research CoordinatorUniversity of California - Davis • Sacramento, CA, United States
Regulatory Senior Clinical Research Coordinator

Regulatory Senior Clinical Research Coordinator

University of California - Davis • Sacramento, CA, United States
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Job ID

82657

Location

Sacramento

Full / Part Time

Full Time

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Job Summary

Under the general direction of the Clinical Research Supervisor, the Senior Clinical Research Coordinator possesses advanced knowledge of regulatory requirements, strong communication skills, and the ability to work effectively in a collaborative team environment. The incumbent independently coordinates, directs, and oversees the overall administration and successful execution of multiple clinical studies. Responsibilities include training and providing direction for new or junior clinical research coordinators and support staff, organizing research meetings, and serving as a key resource for the research team. This 100% appointment works closely with principal investigators, departmental personnel, study sponsors, and community physicians to support and guide all aspects of regulatory coordination, data management, compliance, patient navigation, personnel oversight, and other components of oncology and transplant-related clinical research. This position is grant funded.

Apply By Date : 12 / 8 / 2025 by 11 : 59pm

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

  • Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals.
  • Bachelor's degree in a science or related field, or equivalent combination of education and experience.
  • Five (5) or more years of Clinical Research experience.
  • Three (3) or more years of experience working with a Clinical Trial Management System, such as Velos or Encore.
  • Extensive experience in Industry Sponsored clinical trial processes; clinical and regulatory.
  • Experience working with computer systems and databases, including Windows, Microsoft Office Suite, electronic medical records, and electronic data capture systems for clinical research.
  • Extensive knowledge of FDA and IRB regulations, ICH guidelines and current Good Clinical Practice (cGCP).
  • Extensive knowledge of clinical trial management.
  • Communication skills to convey factual information; to engage in collaborative problem-solving and negotiation with staff and colleagues.
  • Self-directed and able to work independently, meeting the scope of the program with minimal supervision and with frequent changes in priorities and deadlines.
  • Ability to independently exercise judgment, initiative and resourcefulness in making decisions.
  • Demonstrate oral communication and interpersonal skills to effectively correspond with the general 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, and workload priorities can be determined in an appropriate way to accomplish a task or goal. Ability to multi-task.
  • Ability to work cooperatively as a team in a diverse workforce.

Preferred Qualifications

  • Three or more (3+) years of experience in stem cell or oncology clinical trials.
  • Advanced-level knowledge of basic anatomy, medical terminology and ability to interpret physicians' notes, medical records, laboratory and scan results.
  • Advanced-level knowledge and understanding of oncology and disease processes as applied to clinical research.
  • Key Responsibilities

  • 75% - REGULATORY
  • 20% - CLINICIAL TRIAL MANAGEMENT
  • 5% - CONTINUING EDUCATION
  • Department Overview

    The UC Davis Alpha Stem Cell Clinic (ASCC) specializes in early phase, first-in-human trials. The Alpha Stem Cell Clinic is devoted to accelerating the translation of all types of stem cell and regenerative medicine research to safe and effective therapies. It attracts patients, funding agencies and study sponsors to participate in, support, and accelerate novel cell and gene therapy clinical trials and ancillary studies for a range of difficult diseases. The Alpha Stem Cell Clinic is a wide-ranging collaboration with unique contributions launched by the California Institute for Regenerative Medicine (CIRM) through the Alpha Clinic and other grants.

    Department Specific Job Scope

    This position is responsible for regulatory management of studies assigned.

    POSITION INFORMATION

  • Salary or Pay Range : $ 40.79 - $65.59
  • Salary Frequency : Hourly
  • Salary Grade : 100
  • UC Job Title : CLIN RSCH CRD SR NEX
  • UC Job Code : 007889
  • Number of Positions : 1
  • Appointment Type : Staff : Career
  • Percentage of Time : 100 %
  • Shift (Work Schedule) : Day
  • Location : UCD Inst for Regenerative Cure (HSP041)
  • Union Representation : RX-Research Professionals
  • Benefits Eligible : Yes
  • 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 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.

    This position will require an extended number of hours on the computer. General operational schedule 8-5 M-F but must be able to work a flexible schedule for patient needs. Occasional overtime and weekends may be required. Required travel for training and conferences. Walking to and from different sites on the Health System campus several times per day required.

    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

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