#100179 Senior Research Compliance Analyst

Posting will remain open until position is filled. Priority consideration will be given to applications received by Initial Review Date 07/10/2019.

UCSD Layoff from Career Appointment: Apply by 06/26/19 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.

Special Selection Applicants: Apply by 07/10/19. Eligible Special Selection clients should contact their Disability Counselor for assistance.

DESCRIPTION

Under general direction, the Research Compliance Analyst will provide extensive high level analytical support to the Executive Director, Research Compliance and Integrity.

The Research Compliance Analyst will independently conduct complex reviews, auditing and monitoring related to routine and for cause allegations of research/clinical trials noncompliance, ClinicalTrials.gov, Responsible Conduct of Research, NIH Good Clinical Practices training requirements and other targeted research compliance related areas.

The Research Compliance Analyst must be able to independently identify high risk areas, evaluate for non-compliance and best practices, recommend and ensure appropriate corrective actions, gather, evaluate and analyze data, recommend potential solutions, participate in policy development, and provide complex written reports of research compliance activities and trends to the Executive Director. The Research Compliance Analyst will also be responsible to design, develop and provide communications, training and education to the research community, inclusive of faculty and staff.

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. Errors or omissions may ultimately place research participant at undo risk and/or compromise the institution's assurance of regulatory compliance with the federal government.

QUALIFICATIONS
  • A Bachelor's degree plus four (4) years of experience in research and/or research compliance; or an equivalent combination of education and experience.

  • Thorough knowledge and experience with quantitative and qualitative research design; scientific research concepts and terminology.

  • Thorough knowledge and ability to apply all relevant Federal, state, and university regulations, policies, and federal guidance documents.

  • Demonstrated skill in research compliance related monitoring, auditing and/or investigations.

  • Proven ability to understand and interpret, without guidance or supervision, complex general policy guidelines, making independent decisions and initiating action.

  • Demonstrated ability to identify training needs.

  • Excellent communication skills. Ability to write and prepare clear and concise reports, presentations and correspondence. Ability to interact effectively with diverse levels of personnel over telephone, computer and in person.

  • Strong problem-solving skills with ability to analyze situations, identify existing or potential problems, recommend solutions, determine and implement procedures to accomplish effective resolution, and evaluate results or progress.

  • Advanced ability to identify, synthesize and distribute critical sources of news and information on relevant legislative and policy issues related to a variety of research compliance related issues.

  • Ability to work successfully as a member of a team, providing support in a positive, professional and helpful manner.

  • Ability to maintain absolute reliability in handling confidential matters by exercising good judgment, discretion and sensitivity. Self-discipline and sound, independent judgment completing complex assignments.

SPECIAL CONDITIONS
  • Job offer is contingent upon a satisfactory clearance based on background check results

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