Clinical Research Supervisor

Davis•Sacramento, CA

36d•$85,500 - $157,300•Hybrid

About The Position

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

Requirements

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 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 excellent interpersonal skills to communicate in a courteous, professional, effective and informative manner in person and on the telephone with a wide variety of people.
Demonstrated ability to maintain good working relationships with faculty, community-based healthcare professionals, staff and research participants.
Demonstrated ability to work cooperatively as a team member in a diverse workforce.
Demonstrated ability to maintain strict patient confidentiality at all times.
Demonstrated ability to maintain a composed demeanor when interacting with all customers, including those who are ill, angry, confused, or emotionally distressed.
Must maintain up-to-date knowledge and skill levels in area of expertise to ensure provision of the highest quality customer service.
Demonstrated analytical skills to evaluate information, practices and procedures, formulate logical and objective conclusions and make recommendations for effective solutions.
Demonstrated oral communication and interpersonal skills to effectively correspond with the public, co-workers, physicians, patients, caregivers, clinic staff and other health care professionals.
Demonstrated 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.
Demonstrated ability to multi-task.
Demonstrated strong writing and editing skills including ability to compose reports and correspondence while utilizing correct grammar, spelling and punctuation as well as clearly documenting research data onto forms.
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.

Nice To Haves

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

Responsibilities

Clinical Research
Clinical Research Supervisor (CRS) staff supervision
Administrative Management

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.
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.