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University of Delaware

Location: NewarkDE 19702 Document ID: AC122-0GW4 Posted on: 2018-08-2208/22/2018 Job Type: Regular

Job Schedule:Full-time
2018-09-21
 

Senior Research Compliance Coordinator

PAY GRADE: 30E

DEADLINE: OPEN UNTIL FILLED

CONTEXT OF JOB:

The first round of applicant review will include resumes submitted by April 6, with a second round if needed for resumes submitted by April 20.

Under the general direction of the Director of Research Compliance (DRC) and in collaboration with other IRB Office staff members, the Senior Research Compliance Coordinator serves as an IRB Administrator and is responsible for the day-to-day operations of the UD IRB office and the human research protection program. The Sr. Research Compliance Coordinator is accountable for the oversight, implementation, and management of policies and procedures pertaining to human subject research activities. Tasks assigned to the Sr. Research Compliance Coordinator include reviewing, analyzing, and monitoring active human research protocols; ensuring compliance with all federal regulations, IRB Standard Operating Procedures (SOPs), and institutional policies; offering technical support, regulatory guidance, education, and training to faculty, researchers, and the IRB.

MAJOR RESPONSIBILITIES:
  • Administration and management of the IRB protocol review process. This includes assessing submissions for completeness; evaluating studies for their potential risk to participants; reviewing and analyzing research submissions in order to determine the risk level; and using complex regulatory knowledge to determine the most expeditious processing mechanism to be followed for each application.
  • Makes not-human-subjects research and exemption determinations; assigns non-exempt minimal risk research for review
  • Assists in the full board review process as a voting (or alternate) member. Prepares monthly meeting agendas and minutes documentation.
  • Directs and coordinates correspondence from the IRB office to investigators, reviewers, and other institutional IRBs as needed. Serves as a point of contact for the IRB office in multisite/inter-institutional research projects requiring IRB reliance agreements.
  • Serves as an expert resource on IRB requirements and human subjects protection issues. Develops and conducts human subjects training for faculty, staff, students and IRB members. Providing ongoing continuing education activities for IRB members.
  • Assist in the management and support of the ClinicalTrials.gov registration process and portfolio maintenance at UD.
  • Oversees and ensures compliance with complex federal and state regulations related to the protection of human research subjects. May assist in the conduct of periodic audits of research involving human subjects to assess compliance.
  • Assists in the maintenance and updates the Federal IRB registration and the UD Federal Wide Assurance (FWA). Participates in improving organizational performance and compliance components (e.g., required forms, SOPs, record keeping, policies, etc.)
  • Provides support to the DRC and performs other job-related duties as assigned.


QUALIFICATIONS:
  • Bachelor's degree (BA/BS) in a relevant/applicable field required. Advanced degree preferred. Three years of related working experience in human subject protection, research administration, and/or compliance. Certified IRB Professional (CIP) preferred.
  • Demonstrated knowledge and understanding of federal and state regulations pertinent to research with human subjects and clinical trials. Experience with regulatory audits desired.
  • Excellent interpersonal and written/oral communication skills, including the ability to communicate effectively with diverse constituents.
  • Presentation skills and teaching/training experience preferred.
  • Proficient computer skills, including MS Office and database applications. Experience with IRBNet and/or other IRB electronic management systems desired.
  • Must be detail oriented, possess excellent organizational skills, and be able to handle multiple projects simultaneously.
  • Proven developed problem-solving ability and strong analytical capabilities.


Equal Employment Opportunity

The University of Delaware is an Equal Opportunity Employer which encourages applications from Minority Group Members, Women, Individuals with Disabilities and Veterans. The University's Notice of Non-Discrimination can be found at http://www.udel.edu/aboutus/legalnotices.html

To apply please click here!