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.
3 - 5 years Quality assurance/clinical research monitoring
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
Internal Number: 60859
About WellSpan Health
WellSpan Health is a nationally recognized, integrated health system that serves the communities of central Pennsylvania and northern Maryland. Our organization comprises:
• More than 19,000 employees
• 170 patient-care locations
• Eight respected hospitals serving York, Adams, Lebanon, Lancaster and Franklin counties
• A multispecialty medical group that employs more than 1,500 physicians and advanced practice clinicians
• The Joint Commission-accredited Comprehensive Stroke Center
• Level 1 Regional Resource Trauma Center
• Level 3 NICU (WellSpan York Hospital and WellSpan Ephrata Community Hospital)
• Comprehensive Metabolic and Bariatric Surgery Center (MBSAQIP-accredited)
• Central Pennsylvania's most comprehensive behavioral health organization (one of the largest in the country)
• A home care organization
As a mission-driven and physician-led organization, we are committed to transforming the health of the communities we serve and to educating the next generation of physicians, advanced practice clinicians and leaders. Our continued commitment to that mission has led to numerous distinctions and recognitions for our hospitals and facilities. Click here for a... full list.
As a nonprofit, we reinvest in our communities to improve the health and wellness of our patients, as well as those who call central Pennsylvania and northern Maryland home. We also invest heavily in our employees—providing them with new and innovative technologies and treatments, and helping them advance their careers through peer learning, mentorship, cross-training, continuing education and tuition reimbursement. We strive to make life better for our patients, our staff and our communities.