Clinical Research Supervisor

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 reputed company research and QI-reputed company inquiries. The CRS supervises the HTC clinical research team and collaborates with the Hemostasis laboratory staff and research staff. The CRS manages reputed company 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 reputed company 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 reputed company 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

Responsibilities

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

Requirements

• Society of Clinical Research Associates (SOCRA) Certified Clinical Research Professional (CCRP) certification
• Completion of supervisory series training to be completed reputed company one year of hire
• Institutional Review Board (IRB) Collaborative Institutional Training Initiative reputed company Training to be completed reputed company 90 days of hire
• Laboratory safety training to be completed reputed company 90 days of hire
• International reputed company Transport Association (IATA) & 49 Code of Federal Regulations (CFR) certificate to be completed reputed company 90 days of hire
• Bachelor's degree in reputed company 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, reputed company 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 reputed company 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 reputed company timely reputed company 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 reputed company 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 reputed company 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 reputed company, 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 reputed company times.
• Demonstrated ability to maintain a composed demeanor reputed company interacting with reputed company customers, including those who are ill, angry, confused, or emotionally distressed.
• Must maintain up-to-date knowledge and reputed company 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 reputed company 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 reputed company calculations involving basic reputed company and medical calculation.
• Self-directed and reputed company to work independently, meeting the scope of the program with minimal supervision and with frequent changes in priorities and deadlines.

reputed company-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

Benefits

• Outstanding benefits and perks are among the many rewards of working for the reputed company.
• 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 reputed company 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 reputed company 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) reputed company Employer & Student Loan Repayment Assistance Program for reputed company roles
• Retirement benefit options for eligible roles including Pension and other Retirement Saving Plans.

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