Clinical Research Supervisor

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Company: UC Davis Health

Location: Davis, CA 95616

Description:

The Clinical Research Supervisor (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 CRS 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 CRS 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 CRS, 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 CRS 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 the authorship and presentation of posters, abstracts, and articles, locally, regionally, nationally, and internationally. #CA-SB

Apply By Date 3/27/2025 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) Certified Clinical Research Professional (CCRP) certification
  • Completion of supervisory series training to be completed within one year of hire
  • Institutional Review Board (IRB) Collaborative Institutional Training Initiative CITI Training to be completed within 90 days of hire
  • Laboratory safety training to be completed within 90 days of hire
  • International Air Transport Association (IATA) & 49 Code of Federal Regulations (CFR) certificate to be completed within 90 days of hire
  • Bachelor's degree in healthcare or scientific field and/or equivalent experience required
  • At least two years of experience as a clinical research coordinator.
  • At least one-year recent experience supervising/training junior clinical research staff
  • 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.
  • Demonstrated exceptional customer service skills.
  • Demonstrated strong skills in discretion, initiative and resourcefulness and making independent judgments based on sound analysis.
  • Demonstrated organizational skills and attention to detail in maintaining large volumes of records.
  • Demonstrated ability to use analytical and problem-solving skills for the identification and resolution of unique and unforeseen problems in a logical, timely, and often creative manner while maintaining the integrity of study protocols and legalities defined by the University, departmental and study policies and procedures.
  • 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.
  • Demonstrated oral and written communication skills to clearly and concisely provide information, explanations and instructions to, and to elicit information from participants, participant's families, physicians, clinic staff and a wide variety of health care professionals with varying levels of ability to understand.
  • Demonstrated ability to maintain good working relationships with faculty, community-based healthcare professionals, staff and research participants.
  • Demonstrated ability to maintain strict patient confidentiality at all times.
  • Demonstrated analytical skills to evaluate information, practices and procedures, formulate logical and objective conclusions and make recommendations for effective solutions.
  • Demonstrated mathematical abilities to perform calculations involving basic accounting and medical calculation.
  • Self-directed and able to work independently, meeting the scope of the program with minimal supervision and with frequent changes in priorities and deadlines.

Preferred Qualifications
  • Phlebotomy license and experience drawing blood from both pediatric and adult patients
  • Association of Clinical Research Professionals (ACRP) Certification
  • Knowledge of UC Davis Financial information systems, policies, and procedures

Key Responsibilities
  • 60% - Clinical Research
  • 20% - Clinical Research Supervisor (CRS) staff supervision
  • 20% - Administrative Management

Department Overview

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. The Clinical Research Supervisor (CRS) reports directly to the HTC Administrative Officer 3. The HTC is in the Division of Hematology Oncology, Department of Internal Medicine.

POSITION INFORMATION
  • Salary or Pay Range: $ 3,176.25 - $5,858.24
  • Salary Frequency: Bi-Weekly
  • Annual Salary$82,900 - $152,900
  • Salary Grade: Grade 23
  • UC Job Title: CLIN RSCH SUPV 1
  • UC Job Code: 009548
  • Number of Positions: 1
  • Appointment Type: Staff: Career
  • Percentage of Time: 100 %
  • Shift (Work Schedule): Monday - Friday 8:00am-5:00pm
  • Location: Ticon I (HSP087)
  • Union Representation: No, 99 - Non-Represented (PPSM)
  • 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
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

Physical Demands
  • Standing - Occasional Up to 3 Hours
  • Walking - Frequent 3 to 6 Hours
  • Sitting - Frequent 3 to 6 Hours
  • Lifting/Carrying 0-25 Lbs - Occasional Up to 3 Hours
  • Lifting/Carrying 26-50 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
  • Bending/Stooping - Occasional Up to 3 Hours
  • Squatting/Kneeling - Occasional Up to 3 Hours
  • Twisting - Frequent 3 to 6 Hours
  • Climbing (e.g., stairs or ladders) - Occasional Up to 3 Hours
  • Reaching overhead - Frequent 3 to 6 Hours
  • Keyboard use/repetitive motion - Continuous 6 to 8+ Hours

Environmental Demands
  • Chemicals, dust, gases, or fumes - Occasional Up to 3 Hours
  • Loud noise levels - Frequent 3 to 6 Hours
  • Marked changes in humidity or temperature - Frequent 3 to 6 Hours
  • Operating motor vehicles and/or equipment - Occasional Up to 3 Hours
  • Extreme Temperatures - Occasional Up to 3 Hours
  • Uneven Surfaces or Elevations - 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 - Continuous 6 to 8+ Hours
  • Numerical skills - Continuous 6 to 8+ Hours
  • Constant Interaction - Frequent 3 to 6 Hours
  • Customer/Patient Contact - Frequent 3 to 6 Hours
  • Multiple Concurrent Tasks - Frequent 3 to 6 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.

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.

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

To learn more about our background check program, please visit: https://hr.ucdavis.edu/departments/recruitment/ucd/selection/background-checks

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