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    Senior Regulatory Affairs Coordinator - Orange, United States - University Of California Irvine

    University Of California Irvine
    University Of California Irvine Orange, United States

    1 hour ago

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    Description
    Job Opening ID:

    67886


    Reports To:
    Director of Clinical Research Operations


    Working Title:

    SENIOR REGULATORY AFFAIRS COORDINATOR

    Department:
    UCI Ctr for Clinical Research


    Bargaining Unit:

    RX

    FLSA:
    Exempt

    Payroll Job Code:

    007888


    Job Location:
    UCI Campus- Irvine

    Percent of Time:

    100%

    Work Schedule:

    8-5, M-F


    Employee Class:
    Career


    Position Summary:


    The UCI Center for Clinical Research was built on the belief that running clinical trials should be a seamless experience.

    We work across the UCI enterprise to offer patients, investigators, and industry partners the quick and effortless support they need to participate in and run successful clinical trials.


    Our goals are to:
    Innovate - capitalized on opportunities by developing fresh ideas and innovative approaches to improving our daily work.

    Accelerate - Work as a team of teams, driving process simplification, and standardization to surpass our study activation and enrollment targets.

    Grow & Inspire - Set the industry bar for world-class experiences for each other, our patients and partners, and elevate our brand as high performers.

    For more information on CCR, please visit our website at

    The Senior Regulatory Affairs Coordinator position will ensure successful management of the regulatory aspects of each study conducted through UCI's Center for Clinical Research.


    Total Compensation:


    In addition to the salary range listed below, we offer a wealth of benefits to make working at UCI even more rewarding.

    These benefits may include medical insurance, sick and vacation time, retirement savings plans, and access to a number of discounts and perks.

    Please utilize the links listed here to learn more about our

    compensation practices

    and

    benefits

    .
    $ $64.04 (Hourly Rate)

    Department Website:
    Home | Center for Clinical Research | UCI


    Required:
    1-3 years as a Regulatory Affairs Coordinator or the equivalent education or experience
    Associates or Bachelor's Degree. Or the equivalent experience.
    Ability to establish and maintain effective working relationships across the Health System.
    Ability to maintain a work pace appropriate to the workload.
    Must demonstrate customer service skills appropriate to the job.
    Excellent written and verbal communication skills in English.
    Must possess the skill, knowledge and ability essential to the successful performance of assigned duties.

    3-5 years of experience with regulatory aspects of clinical research including maintaining regulatory documents, submitting IRB application, and working with study sponsors and monitors.

    Basic knowledge of Microsoft Word, Excel, PowerPoint. Demonstrated problem solving capabilities.
    Excellent interpersonal communication skills, both oral and written.
    Ability to work under minimal supervision and know how to escalate to proper authorities when needed.
    Ability to comprehend complex documents such as study protocols, guidance documents, and study manuals then synthesize information.
    Ability to prioritize tasks when different stakeholders involved and with competing priorities and deadlines.
    Ability to work well with teams both within and outside of department.
    Ability to work well with teams both within and outside of department.
    Ability to travel to both medical center in Orange or to main office site in Irvine.
    Experience with IND submission.

    Preferred:

    CCRP
    Experience as a clinical research coordinator and/or familiar with the clinical side (versus the regulatory side) of a study.
    Experience with CTMS, preferably OnCore.

    CCRP Certified through one of the national clinical research associations (SOCRA or ACRP) or willing to become certified.
    Familiar with FDA Inspection process.
    Special Conditions

    Required:
    Ability to travel to either Orange Medical Center or main office in Irvine


    Conditions of Employment:
    The University of California, Irvine (UCI) seeks to provide a safe and healthy environment for the entire UCI community.

    As part of this commitment, all applicants who accept an offer of employment must comply with the following conditions of employment:

    Background Check and Live Scan
    Legal Right to work in the United States
    Vaccination Policies
    Smoking and Tobacco Policy
    Drug Free Environment
    The following additional conditions may apply, some of which are dependent upon business unit or job specific requirements.
    California Child Abuse and Neglect Reporting Act
    E-Verify
    Pre-Placement Health Evaluation
    Details of each policy may be reviewed by visiting the following page -


    Closing Statement:
    The University of California, Irvine is an Equal Opportunity/Affirmative Action Employer advancing inclusive excellence.

    All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected categories covered by the UC nondiscrimination policy.

    We are committed to attracting and retaining a diverse workforce along with honoring unique experiences, perspectives, and identities. Together, our community strives to create and maintain working and learning environments that are inclusive, equitable, and welcoming.
    UCI provides reasonable accommodations for applicants with disabilities upon request. For more information, please contact Human Resources at or

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