About the position
Main purpose of the job:
- To assist with the performance of clinical trial-related duties in line with Good Clinical Practice (GCP) standards and be responsible for internal monitoring and validation of participant files to ensure completeness and data consistency and compiling of site regulatory and essential documents to all required stakeholders: Ethics Committees, South African Health Products Regulatory Authority and other regulatory bodies
- Ensure compliance with regulatory requirements within research studies
Location:
- ILTBRU, Jose Pearson TB Hospital, Gqeberha (Port Elizabeth)
Key performance areas:
- Conduct Quality Control activities for clinical trials, assist with regulatory communications and adherence, and train the site personnel in the protocol and its requirements
- Review and Assess Case Report Forms, Informed Consents, and Standard Operating Procedures
- Ensure all queries are attended to appropriately and in a timely manner
- Discuss QC trends with the study team during team meetings
- Pay particular attention to trends in the QC findings and to conduct refresher training where necessary
- Ensure the defined protocol is adhered to at all times
- Ensure all required protocol parameters are followed and recorded accurately at all times
- Ensure study staff is following study standard operating procedures at all times
- Assist with the preparation and follow-up of external monitoring visits and audits
- Training/corrective action for site staff based on QC/QA/External monitoring findings in conjunction with Managers
- Report and track critical events and protocol deviations as notifications occur
- Provide expert guidance on the requirements of local and international regulatory bodies and frameworks, and support the department to comply with those requirements
- Support drafting and submissions of technical reports to IRBs, SAHPRA, and sponsors as needed
- Update site delegation logs when new staff join
- Ensure adequate training is completed by new staff members and training logs completed
- Ensure staff adhere to responsibilities defined in site delegation logs per qualifications and training
- Develop and/or review study-specific SOPs when required
- Prepare site regulatory and essential documents in a timeous and accurate manner to all applicable ethics, regulatory bodies, and sponsors
- Track submissions and approval status
- Maintain regulatory documents
- Conduct internal monitoring of regulatory files
- Generate regulatory reports as required
- Communication with internal and external stakeholders
- Schedule and facilitate training
- Training/corrective action for site staff based on QC/QA/External monitoring findings in conjunction with Managers
- Take ownership and accountability for tasks & activities and demonstrate effective self-management
- Follow through to ensure that quality and productivity standards of own work are consistently and accurately maintained
- Inform relevant parties in the event of tasks or deadlines not met and provide appropriate means of resolution
- Support and drive the business's core values
- Maintain a positive attitude
- Respond openly to feedback
- Take ownership of own career development
- Manage colleagues' and client’s expectations and communicate appropriately
- Willing to help others and go the extra mile to meet team targets and objectives
- Manage own disruptive emotions (handle stress in ways that do not negatively impact the team)
- Ensure all interactions with both internal and external customers are handled professionally
Required minimum education and training:
- Degree in Health Care or Life Sciences
- GCP qualification
- A recognized Quality Control Course (for clinical trials)
- Computer literacy at a higher level including the use of MS Word, Excel, Email, and Internet
Required minimum work experience:
- 3 years of quality control experience in a clinical trial environment
- At least 5 years experience working in clinical trials
- At least 2 years of regulatory experience
Desirable additional education, work experience, and personal abilities:
- Require good organizational, administrative, and analytical skills, time management, and extremely well-organized and resourceful
- Analytical ability, ability to work independently, ability to work in a high-pressure environment, delegation, attention to detail, ability to apply consistent adherence to intentional research and GCP practices
- Ability to communicate effectively within study team and with external stakeholders, very time conscious, flexible, and able to multitask, work independently
TO APPLY:
- Only if you do meet the minimum job requirements and experience as mentioned above, you may submit a detailed updated CV.
- Please Apply Online.
- Please take note that the applicants who do not adhere to the above criteria will not be considered for the respective position.
- The closing date for all applications: 23 April 2024.
- Note AJ Personnel is fully POPI compliant.
- Note WHC, in accordance with their Employment Equity goals and plan, will give preference to suitable applicants from designated groups as defined in the Employment Equity Act 55 of 1998 and subsequent amendments thereto.
Please note:
- AJ PERSONNEL is only responsible for the advertising of the advertisement on behalf of their client Wits Health Consortium.
- Wits Health Consortium will only respond to shortlisted candidates.
- Candidates who have not been contacted within two weeks of the closing date can consider their applications to be unsuccessful.
- AJ Personnel does not have any salary or other information regarding the position.
Desired Skills:
- Communication
- Computer Skills
- Healthcare
- Medical
- Quality Assurance
About The Employer:
Wits Health Consortium (Pty) Limited ("WHC") is a wholly-owned Company of the University of the Witwatersrand, Johannesburg (South Africa) under its Faculty of Health Sciences. WHC provides Faculty with a legal framework within which to operate the research and other activities necessary to support its academic objectives. In addition, WHC offers a range of products and services to the Academics conducting these activities to assist with the management thereof.
