| IRB Manager -- San Clemente, CA |
Author: Jon Merz
Date: 08-06-10 17:36
IRB Manager
Alpha IRB is looking for a motivated manager with prior IRB experience. As Alpha s IRB manager, your main responsibilities would be to manage day to day operations of IRB including meeting scheduling, facilitating and keeping minutes. You would be supervising a skilled team of 4-6 employees. You would be responsible for compliance with regulatory agencies, including FDA and OHRP. You would interact regularly with wide variety of internal and external contacts. You will coordinate meetings with Review board chairperson and other board members, principal investigators, sponsors and academic institutions. Good personal and marketing skills would be desirable for this job.
The IRB Manager would be responsible for:
In collaboration with Study Management Specialist and IRB Administrator, manages the day to day operations of the Institutional Review Board (IRB); plans, and facilitates regular and special meetings of the IRB.
Leading efforts to improve compliance with human subject's protection policies and procedures, with a focus on continuous improvement
Supervises and provides training as needed and evaluates IRB Coordinator and other staff members
Updating and maintaining the IRB SOPs to ensure accurate information and compliance with applicable regulations and guidance
Works with staff members and IRB Chair to prepare annual accreditation reports to maintain accreditation
Applying DHHS and FDA federal regulations for the protection of human subjects to specific research situations
Works with IRB Chair and Medical Director to orient IRB members.
Ensures roster is compliant with OHRP and FDA requirements.
Advises and guides Principal Investigators (PIs) on FDA, HIPAA , OHRO and Alpha IRB regulations, policies, procedures, guidelines, and deadlines on a daily basis and consulting with researchers as needed on IRB requirements or human subjects protection issues
Interacts regularly with a wide variety of internal and external contacts including but not limited to PIs, representatives from federal and state agencies, non-profit agencies, and corporate sponsors of research on a regular basis; provides guidance on the IRB application and review process; interprets IRB regulations, and acts as a liaison to the IRB Chair, Medical Director and external agencies.
Evaluates IRB applications for completeness and conformance to IRB application rules. Alerts IRB Chair and Medical Director to protocol issues that may need closer review
Manages communications to PIs; notifies PIs of IRB decisions, requests additional information when required and coordinates supplementary materials required by the IRB including the preparation and distribution of information
Manages information to support the IRB function including minutes, agendas, and other correspondence. Responsible for working with IRB Coordinator and other staff in compiling and writing of minutes.
Designing and planning special projects designed to enhance office procedures, IRB performance, or overall human subjects protections
Performs job functions adhering to service principles with customer service focus of innovation, service excellence and teamwork to provide the highest quality care and service and other duties as assigned
Knowledge, Skills and Abilities:
Bachelor's degree required, Master's degree in related field preferred.
Prior IRB experience in independent IRB or an academic institution. If you do not have prior IRB experience, but have experience in Regulatory setting in academia or industry, you would be considered.
Certified IRB Professional (CIP) or CIM (Certified IRB Manager) certificate preferred and if you do not have CIP or CIM certificate, we would expect you to take the exam within first of joining Alpha IRB.
Strong interpersonal skills necessary to interact and communicate effectively with Principal Investigators, and sponsors, and to maintain a variety of internal and external contacts.
Possess an excellent verbal and written command of the English language.
Organizational skills: Good problem solving capability to establish priorities and react promptly to a large variety of requests and needs, sometimes in stressful situations.
Demonstrated knowledge of Microsoft Office, Access, Excel, Adobe Acrobat, internet, and other computer software is required.
Qualified applicants may apply for this position via fax to 949-940-0134 or email us at sales@alphairb.com More information about Alpha IRB can be obtained at http://www.AlphaIRB.com/
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