The Center for Clinical and Translational Science
(CCTS) is seeking a Senior Regulatory Specialist to start
immediately. This position develops and manages various clinical study
protocols related to clinical and translational research and oversees related
regulatory requirements to ensure compliance. In addition, develops and
maintains regulatory documents to achieve and maintain compliance with
internal, external and federal policies and regulations that apply to the
conduct of clinical trials. Responsibilities also include senior level
mentoring of regulatory staff and coordination of trainings and ongoing
development, assistance with the development of standard operating procedures
and advance knowledge of specialized regulatory topic
Duties:
·
Collaborate with Principal Investigator and
researchers to develop and implement research protocols in the CCTS. This
includes creating participant consent forms, advertising materials, contact
sheets, etc.
·
Prepare study documents for submission to the IRB,
sponsor or other regulatory authority and correspond with them as needed.
·
Create and review documentation for
institutional approval of: protocols, physicians, and clinical staff to open
and/or continue participation in clinical research protocols from national
clinical trials, industry, external agencies, and internal sources.
·
Review IRB approved documents to ensure accuracy
before protocols are implemented.
·
Maintain accurate, complete and current
information in appropriate format and databases to track clinical research
compliance with FDA, NCI, UIC and sponsored guidelines, i.e. complete and
process appropriate documentation as outlined by FDA, NCI, study sponsors and
the university. Prepare and maintain regulatory binders for each clinical trial.
·
Prepare responses to IRB and sponsor questions.
·
Monitor progress of clinical research study
developments on an ongoing basis. Propose and implement changes as needed.
·
Serve as subject matter expert on regulatory
related issues. Provide regulatory guidance, direction and support to all
members of research team.
·
Keep current on legislation, rules, regulations,
procedures, and development; educate physicians and staff regarding change as
related to clinical research protocols, university staff, affiliates, and
patients.
·
Work with Clinical Research Coordinators and
Research Specialists as needed to ensure understanding of study protocols.
Guide, train, and advise other staff members and students on techniques,
methods, and procedures.
·
Mentor staff and coordinate staff trainings and
ongoing professional development Assist in the development of SOPs, policies
and guidance documents for the CCTS.
·
Keep abreast of and serve as the point of
contact for specialized regulatory topics including, but not limited to, single
IRB review, CTEP registration, single patient INDs, and ClincialTrials.gov
registration and updates.
·
Performs other related duties and participates
in special projects as assigned
Qualifications:
·
A minimum of a Bachelor’s degree in a scientific
discipline required.
·
Minimum of five years of related research
experience; in regulatory compliance required.
·
Minimum 3 years clinical research regulatory
experience required. Knowledge of and experience working with Federal Regulations
and IRBs required.
·
Certification in one of the following: SoCRA,
ACRP, PRIM&R preferred and required within 2 years of hire.
·
Strong communication skills; ability to
communicate clearly and concisely both in written and verbal communication
For fullest consideration please submit application to
the UIC Job Board https://jobs.uic.edu/job-board/job-details?jobID=105337&job=senior-regulatory-specialist-ccts by December 21, 2018
The
University of Illinois at Chicago is an Equal Opportunity, Affirmative Action
employer. Minorities, women, veterans and individuals with disabilities are
encouraged to apply.
The University of Illinois may conduct background checks on all job candidates upon acceptance of a contingent offer. Background checks will be performed in compliance with the Fair Credit Reporting Act.
