Quality Assurance Reviewer IRB/ORP

Description:
Could you be the next Quality Assurance Reviewer at Main Line Health?

Why work as a Quality Assurance Reviewer with Main Line Health?

• Make an Impact! Under the general supervision of the Office of Research Protections (ORP) Director, the Quality Assurance (QA) Reviewer-Office Research Protections is a compliance professional responsible for evaluating, promoting and ensuring regulatory compliance on behalf of researchers, research support and service offices, departments and individuals providing services or assistance in the conduct of research activities. The QA Reviewer is a human research Good Clinical Practice (GCP) and regulatory compliance subject-matter expert, experienced in providing education and outreach programs in person and/or web-based training seminars, leading policy and compliance training. The QA Reviewer provides a strong supportive role in human research protection program (HRRP) review activities and application of the AAHRPP accreditation standards. The ORP QA Reviewer's mission is fulfilled by working with investigators and their team members to identify opportunities to achieve and maintain compliance with approved protocol activities and expected research conduct standards. Support is provided to assist investigators in meeting required regulatory authority research compliance performance expectations, to ensure that research follows acknowledged best practices, and fulfills applicable standards, policies and written agreements. The QA Reviewer readily takes on additional tasks and initiates necessary processes to ensure MLH research compliance standards are met.
  
  
• Develop and Grow your Career! Invest in furthering your education through seeking certifications or advanced degrees by taking advantage of our Tuition Reimbursement! This position is eligible for up to $6,000 per year based upon your Full or Part Time status.
  
  
• Join the Team! Like our patients, the Main Line Health Family encompasses a wide range of backgrounds and abilities. Just as each of our patients requires a personalized care plan, each of our employees, physicians, and volunteers, bring distinctive talents to Main Line Health. Regardless of our unique design, we all share a purpose: providing superior service and care.
  
  
• Position-Specific Benefits include: You are eligible for 200 paid time off per year. We also offer a number of employee discounts to various activities, services, and vendors... And employee parking is always free!
  
  

Position: Quality Assurance Reviewer ORP
Shift: (Full-time) 40 hours per week

Experience:
Prior employment in a clinical research/human research protection quality assurance role and or clinical research coordinator related experience (2 years). Experience with database management systems (2 years). Strong understanding of federal regulations and guidance documents, HIPAA/Privacy, ICH-GCP preferred (2 years).

Education:
1. Bachelor's degree in the health sciences required. Demonstrated equivalent training and experience may be considered.
2. Master's degree preferred.

Licensures/Certifications:
Achieve and maintain current certification in IRB focused CITI/equivalent and regulatory training, Certified IRB Professional ("CIP") preferred or obtained within 3 years of hire. Certification in quality assurance and/or research compliance and regulatory practices (example: ACRP, CCRC, RQAP-GCP)