IRB Secretary

Job Responsibilities

• Secretariat Management: Providing administrative and secretarial support to HKU-GHK IRB and its Governance Committee (GC); Maintaining HKU-GHK IRB’s policies and standard operating procedures; Scheduling application review meetings; Maintaining records of applications and related documents; Maintaining meeting documents such as agendas and minutes; Preparing regular reports on HKU-GHK IRB’s activities; Providing support (in the domain of research ethics) with respect to GHK’s participation in relevant registration, certification or accreditation schemes, and facilitating relevant audits and inspections.

• Membership Management: Providing administrative and secretarial support in relation to nomination and appointment of members to HKU-GHK IRB; maintaining membership records (such as members’ biographies, statements of confidentiality, declarations of conflicts of interest, and training records); Organizing relevant training for HKU-GHK IRB members.

• Coordination of Initial Applications and Review Meetings: Receiving applications for ethics and scientific evaluation of research projects; Checking for completeness of application documents and communicating with applicants; Distributing application documents to HKU-GHK IRB members and consolidating pre-meeting comments; Organizing review meetings; Preparing meeting minutes; Preparing notices of decisions to applicants; Coordinating relevant follow-up actions.

• Facilitation of Continuous Oversight of Research Projects: Receiving submissions of project amendments, new information, deviation reports, safety reports, and regular/final reports; Facilitating review of such submissions by HKU-GHK IRB members; Preparing written notices of decisions to applicants; Coordinating relevant follow-up actions.

• Consultation on Research Application Requirements and Research Ethics/Regulatory Affairs: Advising investigators, HKU-GHK IRB members and management of GHK on the policies, procedures and requirements applicable to research applications and on other research ethics and regulatory affairs.

• Other Assigned Duties: Performing other duties as assigned by the GHK Chief Executive Officer or the HKU-GHK IRB Chairperson, as appropriate. Such responsibilities may include keeping abreast of the latest local and international research ethics and regulatory requirements, organizing training for investigators and clinical research personnel, and facilitating implementation of quality improvement and quality assurance programs.

Requirements

• Bachelor’s degree, with preference for Biological, Medical or Life Sciences or equivalent
• Relevant experience is not necessary while strong knowledge of research ethics, relevant regulatory requirements, and research ethics evaluation process are desired values
• Good computer skills are required in using office software
• Detail-minded, self-disciplined with good problem-solving, interpersonal and communication skills
• Proficient in oral and written English and Chinese Proactive, independent, punctual, good time and project management