Description of Purpose:
• The successful candidate will be responsible for Quality Control (QC) activities in support of the assigned studies at MU-JHU.
Required qualifications & profile:
• A minimum of a diploma in nursing, clinical medicine, or any related medical training with at least 3 years of experience working on clinical research. Up-to-date professional accreditation and certifications in GCP and HSP. Intermediate or advanced computer proficiency e.g. in Microsoft package (word, outlook, PowerPoint, Excel, etc.). Experience in Electronic data capture (EDC) systems would be a strong advantage. Aptitude and proficiency for role, including strong attention to detail, professional integrity, and motivation to maintain proper research documentation and MU-JHU’s reputation for research excellence. Capability as a proactive team player with excellent interpersonal, oral and written communication skills, time management and multitasking abilities, and the ability to prioritize and work effectively and efficiently in a fast-paced environment.
The holder of this position will work under the direct supervision of the Quality Control Supervisor with guidance from the Quality Management Division Director, and will be responsible for the following duties:
• Remain up to date with the current study-specific protocol and procedures as well as related GCP and Human Subject Protection requirements and required trainings.
• Review study records prior to expected visits to ensure required forms are prepared and filed appropriately prior to the expected visits.
• Review chart notes, paper, and or electronic CRFs of research participants to ensure adequate completion, consistency, and accuracy and that procedures done are in compliance with the study protocol and other ethical and sponsor regulations.
Communicate promptly to the Study Principle Investigator and Study Coordinator or designee for
• any participant safety issues as well as any key data/documentation issues.
• Provide timely feedback on QC findings to the Study Coordinators and study teams to enable the implementation of preventive actions and for overall quality improvement.
• Ensure that identified errors are resolved in a timely manner and within approved SOPs and the study protocol.
• Applications with complete C.Vs, including 3 referees and their full addresses or contact Tel No.’s, copies of academic certificates and testimonials, should be hand delivered to: MU-JHU Director Human Resources, through the reception on first floor, MUJHU 1 Building or sent by email (application should not exceed 15MBs) to HR@mujhu.org – not later than 22nd December 2022 by 5.30pm. • Only short-listed applicants will be contacted.