Clinical Research Supervisor (CLIN RSCH SUPV 1)

The Clinical Research Supervisor (CRS) reports directly to the HTC Program Director. The HTC is in the Division of Hematology Oncology, Department of Internal Medicine. The CRS manages the HTC’s entire clinical research program, including quality improvement and clinical trials. The CRS works with the PI’s in portfolio decision-making, representing them in all research and QI-related inquiries. The successful applicant supervises the HTC clinical research team and collaborates with the Hemostasis laboratory staff and research staff. The CRS manages complex Health Resources and Services Administration (HRSA) grants (in collaboration with the PI’s and research administrator), Centers for Disease Control and Prevention (CDC) data collection, QI projects and outcomes, and both industry-sponsored and investigator-initiated research. The CRS works with the PI’s and Program Director to strategically plan and shape the research portfolio. The successful applicant also supports the development, regulatory compliance, and conduct of the clinical trials research unit. Under the direction of the PI’s and management of the Clinical Research Supervisor, the research team uses statistical and epidemiological concepts to develop research and QI projects, coordinate data collection, outcomes measurement, statistical analysis, and submission requirements on behalf of the HTC as determined by the two federal grants (HRSA and CDC).
The successful applicant is also responsible for all aspects of the pharmaceutical clinical trial processes, including but not limited to clinical trial budget preparation, sponsor negotiation, IRB initial application, modifications, renewals, and closeout, FDA and other government regulatory compliance, audits, sponsor invoicing, and ongoing monitoring of clinical trial protocols and compliance. The CRS performs and oversees specimen preparation, data and database management, patient scheduling/billing for research, GLP and GCP. The CRS ensures that local and national research and QI initiatives are focused, efficient and effective. The CRS helps with authorship and presentation of posters, abstracts, and articles, locally, regionally, nationally, and internationally.

Apply By Date

April 29, 2024 at 11:59pm

Minimum Qualifications

• Bachelor’s degree in healthcare or scientific field.
• SOCRA and/or CCRP certification
• Minimum two years of experience as a clinical research coordinator.
• Minimum one-year recent experience supervising/training junior clinical research staff.
• Completion of supervisory series training within one year of hire
• Demonstrated experience working with computer systems and databases, including Windows, Microsoft Office Suite, electronic medical records, and electronic data capture systems for clinical research.
• Experience working with FDA regulations, ICH guidelines, Good Clinical Practice (GCP), federal and Institutional Review Board guidelines.
• Experience coordinating a broad range of activities from inception to implementation within the confines of strict study protocols, University and departmental policies and procedures.
• Experience managing multiple study finances, negotiating budgets, creating and analyzing financial spreadsheets.
• Experience in independently organizing tasks and set priorities for work assignments to achieve timely progress on multiple tasks simultaneously, to meet deadlines and maintain a high level of productivity.
• Advanced-level knowledge and understanding of basic anatomy and medical terminology, as applied to clinical research and ability to interpret physicians’ notes, medical records, laboratory, and scan results.
• *IRB CITI training
• *Laboratory safety training
• *IATA & 49 CFR certificate

*All departmental required trainings must be completed within 90 days of employment.

Preferred Qualifications

• Phlebotomy license and experience drawing blood from both pediatric and adult patients
• ACRP Certification
• Knowledge of UC Davis Financial information systems, policies, and procedures

Department Description

The UCD Hemostasis and Thrombosis Center (HTC) is a federally funded and registered treatment center offering clinical research, comprehensive medical care, and outpatient 340B pharmaceutical services to persons with bleeding and clotting disorders. Receipt of federal funding requires the HTC to perform research and quality improvement (QI) projects, participate in national patient data-collection, and improve program performance and outcomes.

Position Information

• Salary or Pay Range: $3,076.80 - $5, 651.20
• Salary Frequency: Bi-Weekly
• Payroll Title: CLIN RSCH SUPV 1
• Salary Grade: 23
• Number of Positions: 1
• Appointment Type: Career
• Percentage of Time: 100% 
• Shift Hours: 08 Hours
• Location: Sacramento, CA
• Union Representation: No
• Benefits Eligible: Yes
• Hybrid/Remote/On-Site: On-site

THIS IS NOT AN H1B OPPORTUNITY

Benefits

Outstanding benefits and perks are among the many rewards of working for the University of California. UC Davis Health 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.  The master templates for both represented and non-represented positions can be found  here .

• 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 Maternity, Paternity, Family & Medical Leave
• 14 paid Holidays annually
• Vacation/Paid Time Off 
• Sick Leave with unlimited accrual
• Continuing Education (CE) allowance and Education Reimbursement Program
• Access to free professional development courses and learning opportunities for personal and professional growth
• Wellness and on-site Employee Assistance Program including access to free mental health services
• Supplemental insurance offered including additional life, disability, short/long term disability, pet insurance and legal coverage
• Public Service Loan Forgiveness (PSFL) Qualified Employer & Student Loan Repayment Assistant 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
• UC Davis cares about building a community, which is why we provide resources to enhance diversity, equity and inclusion as well as Employee Resource Groups (ERGs) to support our staff

Special Requirements

• This position is a critical position and subject to a background check. Employment is contingent upon successful completion of background investigation including criminal history and identity checks.
• As a condition of employment, you will be required to comply with the University of California Policy on Vaccination Programs , as may be amended or revised from time to time.  Federal, state, or local public health directives may impose additional requirements.  

Diversity, Equity, Inclusion and Belonging

At UC Davis, we’re solving life’s most urgent challenges to bring a fuller, healthier, and more resilient world within reach. We grow from every challenge we take on and we don’t just maintain - we improve. We recognize that creating an inclusive and intellectually vibrant organization means understanding and valuing both our individual differences and our common ground. The most comprehensive solutions come from the most diverse minds, and you belong here. As you consider joining UC Davis, please explore our Principles of Community , our Clinical Strategic Plan and strategic vision for research and education, and our latest efforts to outgrow the expected . The University of California, Davis is an Equal Opportunity/Affirmative Action Employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age or protected veteran status. 

For the University of California’s Affirmative Action Policy please visit: https://policy.ucop.edu/doc/4010393/PPSM-20 . 

For the University of California’s Anti-Discrimination Policy, please visit: https://policy.ucop.edu/doc/1001004/Anti-Discrimination .

Because we want you to be seen, our recruiting process at UC Davis fosters authenticity, diversity, and inclusion. Studies have shown that some people may not apply to jobs unless they meet every single qualification. Each unique role at UC Davis has a set of requirements and you could be perfect for this role, or you could be perfect for the next role! Don’t meet all the requirements? We still encourage you to apply! #YouBelongHere