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UC Davis Health · 12 hours ago

Research Compliance Analyst 2 or 3

Sacramento, CA

Full-time

Hybrid

Mid, Senior Level

$30.60/hr - $53.69/hr

UC Davis Health is dedicated to providing regulatory support to Internal Medicine’s Research Units. The Research Compliance Analyst ensures high-quality regulatory compliance across multiple studies and research units, managing regulatory submissions and providing guidance to research personnel.

AssociationCommunitiesEducationHealth CareHospital

Comp. & Benefits

Responsibilities

90% - Research Administration Regulatory Oversight

10% - Miscellaneous

Qualification

Clinical research regulationsFDA regulationsClinical Practice (GCP)Clinical research coordinatorECOIE-regulatory systemsOrganizational skillsAnalytical skillsLeadership skillsCommunication skillsAttention to detail

Required

Bachelor's degree in a related field or a combination of experience, education or training required

Foundational experience as a clinical research coordinator (or equivalent)

Knowledge and understanding of FDA regulations, ICH guidelines, Good Clinical Practice (GCP), federal and Institutional Review Board guidelines

Experience in 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

Experience working with computer systems and databases, including electronic medical records, eCOI, e-regulatory (CTMS and Oncore), and electronic data capture systems for clinical research

Extensive experience as a clinical research coordinator (or equivalent)

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

Experience working with computer systems and databases, including electronic medical records, eCOI, e-regulatory (CTMS and Oncore), and electronic data capture systems for clinical research

Excellent skills to exercise discretion, initiative and resourcefulness and make independent judgments based on sound analysis

Leadership skills encompassing both training and ongoing mentoring of junior research team members

Organizational skills and attention to detail in maintaining large volumes of records

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

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

Display writing skills including ability to compose reports and correspondence while utilizing correct grammar, spelling and punctuation as well as clearly documenting research data onto forms

Preferred

Ability to serve as a role model; demonstrate a customer-service orientation and hold self-accountable for achieving service excellence

Ability to maintain good working relationships with faculty, community-based healthcare professionals, staff and research participants

Ability to work cooperatively as a team member in a diverse workforce

Ability to maintain a composed demeanor when interacting with all stakeholders, including those who are ill, angry, confused, or emotionally distressed

Have the ability to work independently and be self-directed, meeting the scope of the program and with the frequent changes in priorities and deadlines

Benefits

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.