GENERAL SUMMARY:
Under the general supervision of the Manager-Human Research Protection Program (HRPP), performs duties related to the Research Quality Assurance (QA) program. Performs audits of human subject research studies to ensure compliance. Implements QA activities for the HRPP and Institutional Review Board (IRB). Creates tools to measure and track compliance and provides reports as requested. Assists with tracking metrics and preparing reports for accrediting agencies. May serve as IRB Coordinator and conduct administrative IRB-related tasks. Performs other duties as requested.
DUTIES AND RESPONSIBILITIES:
1 Conducts structured audits of human subject research records across the Health System. Reviews research records, including regulatory files and subject records, to facilitate and ensure compliance with the requirements of the IRB approved protocol, WSH IRB policies, applicable Federal Regulations, Good Clinical Practice, and other regulatory requirements.
2 Develops tools and templates to assist with conducting structured audits.
3 Assists research and study team members to prepare regulatory files prior to study initiation and reconcile errors found in research related record keeping practices. Provides guidance on developing corrective and preventive action plans and reporting requirements, when applicable.
4 Develops and maintains database to track audit findings and corrective measures. Analyzes audit findings for significant trends or occurrences. Provides regular reports and updates to HRPP Manager, IRB Executive Committee, Institutional Official or another identified person(s).
5 Assists in the development and administration of educational material in regard to research record keeping, research compliance, WellSpan Health IRB Policy and Procedures for Research, Federal Regulations, and Good Clinical Practices.
6 Assists in determining and tracking quality indicators for research. Prepares regularly scheduled or special reports, analyses, and statements.
7 Conducts routine audits of HRPP and IRB processes.
8 Evaluates procedures, suggests actions to resolve problems, and suggests changes to improve performance, with input from HRPP Manager and IRB Executive Committee.
9 Assists in maintaining IRBNet, the web-based management system, for tracking IRB protocols including new protocols, protocol/consent modifications, annual reviews/re-approvals, safety reports and adverse event documentation.
10 May perform IRB coordinator duties as assigned, including coordinating with research department staff to facilitate work flow processes and activities pertaining to IRB submission; providing technical support for IRBNet and CITI program; publishing IRB correspondences; assisting with preparing for IRB meetings; and attending Board meetings.
11 Securely maintains all IRB records with restricted access as appropriate including agendas, minutes, policies, regulations, reference materials and individual protocol files. Ensures only authorized personnel have access to confidential data/records/information. Reports any security breach immediately.
12 Prepares reports of protocol status and other reports as requested to the IRB Executive Committee, WellSpan Administration or regulatory agencies.
Required Skills
Minimum Education
Bachelor's Degree
Minimum Experience
3 - 5 years Quality assurance/clinical research monitoring
Pref. Cert/Registration
Certification as a Clinical Research Associate (CRA), Clinical Research Coordinator (CCRC) or Clinical Research Professional (CCRP) or equivalent certification or willing to become certified within 2 years of eligibility.
Ideal applicants have advanced understanding and working knowledge of human subject research regulation, law, policy, and Good Clinical Practice
Possesses an in-depth understanding of research compliance and conduct as it relates to human subject research and IRB functions
Good documentation practices (GDP)
Strong database and computer skills excellent written and verbal communication skills
Required Experience
Minimum Education
Bachelor's Degree
Minimum Experience
3 - 5 years Quality assurance/clinical research monitoring
Pref. Cert/Registration
Certification as a Clinical Research Associate (CRA), Clinical Research Coordinator (CCRC) or Clinical Research Professional (CCRP) or equivalent certification or willing to become certified within 2 years of eligibility.
Ideal applicants have advanced understanding and working knowledge of human subject research regulation, law, policy, and Good Clinical Practice
Possesses an in-depth understanding of research compliance and conduct as it relates to human subject research and IRB functions
Good documentation practices (GDP)
Strong database and computer skills excellent written and verbal communication skills