| Protocol Analyst -- Winston-Salem, NC |
Author: Joseph Andrews, Jr. MA, CIP
Date: 03-18-10 20:51
The Protocol Analyst will manage the administrative and business process of the Institutional Review Board in support of complex research protocols including review, interpretation and coordination of procedural activities within the overall scope of relevant federal, state, and local regulations for research involving human subjects at Wake Forest University School of Medicine. He or She will:
1. Act as the primary interface with faculty, students, and staff regarding all matters of the assigned committee. Independently answer queries and provide authoritative information regarding regulatory issues and protocol status.
2. Screen protocols for completeness, check database to ensure all personnel have completed appropriate mandatory training.
3. Conduct a pre-review of proposed studies, correspond with investigators to resolve questions or concerns, and assign appropriate committee members to conduct the final review of the protocol.
4. Provide guidance to researchers pertaining to research rules and regulations. Advise faculty on WFUHS policies and procedures as well as federal policies and guidelines.
5. Arrange, implement and participate in conferences, board meetings and training sessions.
6. Work with the Grants Office to ensure that all grant applications that propose to use humans have an IRB approved protocol.
7. Maintain the relevant databases as necessary to maintain current and accurate records.
8. Arrange, implement, and participate in all educational sessions for board members regarding policies, processes, and procedures. Educate faculty, staff, and students on updates to the protocol submission software.
9. May provide direction and guidance to support personnel.
10. Perform other related duties incidental to work described herein.
QUALIFICATIONS
1. Bachelor's degree and two years of related experience, or equivalent combination of education and experience, as well as strong communication skills and the ability to handle multiple projects, are required. Experience in a research environment is preferred.
Persons interested in this position should apply at
https://www.hrfin.wfubmc.edu:8022/psp/pspro/EMPLOYEE/PSFT_HR/c/HRS_HRAM.HRS_CE.GBL
Choose "Advanced Search" and query "Job Opening ID": 13425 to access job description and application link.
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