HSCRO/EQUIP Sr. Analyst Job at University of California, Irvine, Irvine, CA

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  • University of California, Irvine
  • Irvine, CA

Job Description

Overview:

Founded in 1965, UC Irvine is a member of the prestigious Association of American Universities and is ranked among the nation’s top 10 public universities by U.S. News & World Report. The campus has produced five Nobel laureates and is known for its academic achievement, premier research, innovation and anteater mascot. Led by Chancellor Howard Gillman, UC Irvine has more than 36,000 students and offers 224 degree programs. It’s located in one of the world’s safest and most economically vibrant communities and is Orange County’s second-largest employer, contributing $7 billion annually to the local economy and $8 billion statewide.
To learn more about UC Irvine, visit .

HRP within the Office of Research is responsible for ensuring the ethical and equitable treatment of all human research subjects in studies conducted by UCI faculty, staff, and students. It is also responsible for ensuring compliance with federal regulations, state laws and University polices, as well as national standards for research involving human participants.
Within HRP, EQUIP monitors and measures the effectiveness, efficiency, and quality of UCI's human research protection program. It does this by conducting education, training, and post-approval monitoring activities.
The HSCRO Committee is charged with assuring human stem cell activities are in accordance with applicable federal and state regulations as well as institutional requirements are in accordance with California Department of Public Health (CDPH), California Institute of Regenerative Medicine (CIRM), and applicable UCI policies and procedures.

Responsibilities:

Under the general direction of the EQUIP Manager, this position is responsible for development, implementation, and administration of the Human Stem Cell Research Oversight Committee (HSCRO), and clinicaltrials.gov compliance coordination, and provide post-approval monitoring as part of the Education and Quality Improvement Program (EQUIP). Serves as the primary point of contact for day-to-day operation and management of these programs, for oversight and monitoring of processes to promote and facilitate compliance with all applicable laws, regulations, policies and procedures.
Uses skills as a seasoned, experienced research compliance professional with a full understanding of industry practices and organization policies / procedures to apply federal, state, and university regulations, policies, and guidelines, and promote best practices. Interacts frequently with investigators, persons in other organizational departments, and occasionally persons outside the University. Interactions require the use of tact and independent judgment, knowledge of standards and best practices, and counseling to resolve a wide range of research compliance issues. Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
Conducts periodic study monitoring and other quality improvement activities, including for cause reviews and investigations. Responsible for oversight of clinical trials.gov oversight for non-School of Medicine protocols. Errors or omissions may ultimately place research participants at undue risk and / or compromise the institution's assurance of regulatory compliance with the federal government, and placing the University at increased legal, financial, and reputational risk.
NOTE: This is primarily a remote position. Infrequently, this position may need, or be required, to work on campus.

Qualifications:

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 .


The expected pay range for this recruitment is $77,000- $92,550 (Annual).

Required:

  • Demonstrated self-discipline and sound, independent judgment completing complex assignments.
  • Thorough knowledge and ability to apply all relevant Federal, state, and university regulations, policies, and federal guidance documents.
  • Thorough knowledge and experience with quantitative and qualitative research design; scientific research concepts and terminology.
  • Demonstrated proficiency in public speaking, and writing.
  • Demonstrated ability to conduct comprehensive, detailed analyses of complex regulations.
  • Time management skills and the flexibility to accommodate changing priorities in unit.
  • Proficiency with computers, including the ability to operate personal computer software with sophisticated retrieval, storage, and merging capabilities.
  • Bachelor's degree in related area and / or equivalent experience / training.
  • 3-5 years of experience in human subjects research and/or stem cell research administration, or an equivalent combination of education and experience.


Preferred:

  • Working knowledge of UCI HRP unit and UC/UCI Human Research Protections policies and procedures.
  • Certified IRB Professional (CIP)


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
  • Employment Misconduct*
  • Legal Right to work in the United States
  • Vaccination Policies
  • Smoking and Tobacco Policy
  • Drug Free Environment

*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.

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 is an Equal Opportunity Employer. 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 Anti-Discrimination 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 (949) 824-0500 or eec@uci.edu.

Job Tags

Full time, Local area,

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