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Posting DetailsPosting Number: 20244240S
Position Title: IRB Manager
Position Type: Staff
Location: Villanova, PA
Recruitment Type: Internal/External Applicants
Work Schedule: full-time/12-months
Avg Hours Week: 35
Department: 918 - Office of Research Protections
Position Summary: The IRB Manager is responsible for the efficient management of IRB functions to assure protection of human subjects involved in research.
The IRB manager provides regulatory expertise, guidance and administrative support to the Institutional Review Board (IRB) reviewing human subject research protocols and Villanova researchers engaging human subjects.
Duties and Responsibilities: Manages general IRB review workflow.
Processes researcher submissions via the online protocol system.Coordinates the review process by assisting in preparing submitted protocols for IRB action; assigning reviewers for protocol submissions; providing determination letters to Investigators.Prepares for the monthly IRB meeting including setting agendas, writing minutes and producing other materials.
Prepares agreements for ORP Director review.Conducts exemption determinations, administrative approvals, and other ad hoc review procedures on behalf of the IRB.Manages office documentation related to approvals and study details and SOPs and Policies (10%).Assists investigators in the electronic submission process and protocol review process as required.
Participates in education and training for researchers and IRB members.Develops and implements communication plans for messaging to IRB members and University community; drafts briefings, updates website, manages social media.Performs other duties and assists with projects as assigned.Minimum Qualifications: Formal Education: Bachelor's degree (required).Minimum Work Experience: 3-5 years' experience in IRB administration required.Preferred Qualifications: Certified IRB Professional (CIP) preferred.Familiarity with US Human Subjects Research Regulations.Expertise in assessing ethical conduct of human subjects research.Experience following and overseeing adherence to policies and procedures.Independent time and project management.Excellent written and verbal communication skills with diverse audiences.Excellent customer service skills.Maintain discretion and confidentiality in all professional matters.Software knowledge: Microsoft Office, Cayuse Human Ethics (preferred).Physical Requirements and/or Unusual Work Hours: Special Message to Applicants: Posting Date: 01/07/2025
Closing Date (11:59pm ET):
Salary Posting Information: Commensurate with experience.
Salary Band: 16
Job Classification: exempt
References NeededMinimum Number of References Needed: 3
Maximum Number of References Needed: 3
Supplemental QuestionsRequired fields are indicated with an asterisk (*).
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Documents needed to complete your application:Required Documents: Cover Letter / Letter of InterestResume / Curriculum VitaeOptional Documents: Other Document
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