Family Group: Administration
JOB PURPOSE
The Analyst needs to ensure that the NHG Office of Human Research Protection Programme (OHRPP) provides the highest level of administrative support services for ethics, thereby ensuring the sustainability of a robust and effective research ethics review process.
The Analyst will assist the Manager to manage the operations of the Domain-Specific Review Boards to ensure that they meet their primary responsibilities of protecting the rights and welfare of human research subjects.
MAJOR DUTIES & RESPONSIBILITIES
- Ethics Policy Management
a) Assists the Manager in preparation, regular review and update of research ethical guidelines, policies and standard operating procedures.
b) Perform secretariat duties to the NHG REC, if appointed.
c) Ensures that REC meeting minutes are in sufficient details to document boards deliberations.
- Ethics Review and Approval Process and Procedures
- 1 Ensuring Quality of Review
a) Ensures that research protocols submitted to assigned Domain are reviewed efficiently and consistent with the applicable regulations, guidelines and policy
b) Ensures that the Review Boards reviewing processes are properly conducted, including meeting agendas, ensuring quorum, and document minutes of the meetings and follow up actions including correspondence to Investigators/ Sponsors.
c) Ensures that meeting minutes are in sufficient details to document review boards deliberations.
- 2 Ensuring Timeliness of Review
a) Screens and reviews applications and correspondence received by the review boards and to oversee the accurate and timely processing, of submissions to and actions by the review board.
b) Manage Domain operations and meetings
- 3 Participate in Quality Improvement
Improve ethics approval process and effectiveness of review, as part of continuous improvement project
- 4 Serve as resource for Investigators and researchers regarding the adaptation and implementation of DSRB policies, procedures and forms.
- 5 Effectively communicate and document all communications with Sponsors, Investigators, review board members and regulatory authorities.
- 1 Assists in preparing DSRB-related reports on ethics and other topics.
- 2 Maintains an accurate, comprehensive and up-to-date database of all applications.
- Operational Matters of Administrative Support Office
- 1 Be involved in cross coverage plans for other Domains.
- 2 Performs any other ad-hoc job-related duties as assigned.
- 3 Serve as the Secretariat of Ethics conferences/programs.
JOB REQUIREMENTS
Education/Training/Experience
Degree, preferably in Science / Life Sciences / Nursing / Pharmacy / Health Sciences
Relevant experience in healthcare, research and related training would be an advantage.
Displayed basic understanding of research ethics policies and local regulations
A relevant degree in areas such as Life Sciences, Allied Health would be advantageous
Demonstrate basic knowledge and skills in quality and process improvement approaches
Possess good organization, project management and preferably with data analytical and good writing skills
Personal Attributes
Demonstrated good inter-personnel and influencing skills in working with different groups of stakeholders
Team-player, demonstrates excellent team spirit and skills in supporting teams and managers
Ability to influence and motivate people
Ability to handle and manage stressful situations and work independently under pressure
