SUMMARY:
A Site Coordinator (ending November 2022) vacancy is available at our Client, Wits Health Consortium's Nelson Mandela Academic Clinical Research Unit (NeMACRU) in Mthatha - Eastern Cape.
POSITION INFO:
Background
The Nelson Mandela Academic Clinical Research Unit (NeMACRU) is a research entity of the Nelson Mandela Academic Hospital established by the hospital in association with the Walter Sisulu University, Faculty of Health Sciences. NeMACRU is located in one of the poorest districts (OR Tambo District Municipality) of the Eastern Cape Province. The existence of this site will not only promote excellent research output in the area but will support local health facilities with health education on vaccines and HIV Prevention.
Main purpose of the job
- To coordinate site activities and provide regulatory administrative services to the trial
Location
Key performance areas
- Coordinate trial activities for all active protocols (from initiation to close out)
- Administration of relevant policies and procedures
- Manage the administration processes by ensuring effective controls are in place
- Provide administrative support for the operational start-up for new clinical trials
- Support quality control and monitoring processes
- Participate in or facilitate relevant meetings and schedule meetings when required
- Coordinate and update training required for the team
- Assist the team with ad hoc administration assignments and duties
- Administer the regulatory requirements of the site and support the Principal Investigator and Contract Management Support by identifying, compiling, and submitting information (CV’s, signatories, declarations, workloads, etc.) necessary to obtain regulatory approvals
- Maintain all certificates i.e. GCP, HPCSA, Pharmacy Council, Nursing Council, MPS, etc.
- Maintain regulatory files i.e. preparing collations and copies for SAHPRA and Ethics submissions
- Obtain signatures for other clinical trial documents i.e. financial agreements, FDA documents, protocol signature pages, approval documents, etc.
- Update tracking tools for regulatory submission documents
- Maintain a submission planning list for each submission cycle to monitor follow-up of submission deadlines
- Obtain required FDA1572 forms and/or equivalent to track these
- Maintain study start-up checklists
- Liaise with the Research Director/Principal Investigator, sponsors, and the sites clinical team for regulatory administration purposes
- Prepare, update, and maintain regulatory document and site files
- Ensure that study termination occurs smoothly
Required minimum education and training
- Diploma or Bachelor''s Degree in a related field
Desirable additional education, work experience and personal abilities
- Exceptional organizational and administrative skills with working knowledge of Microsoft Word and Office
- Able to maintain confidentiality, and exercise tact and professionalism always
- Able to exercise discretion, high levels of initiative and independent decision-making
- Must be assertive, confident and adaptable
- Self-motivated, able to work independently and work as part of a multidisciplinary team
- Required to spend long hours sitting and using office equipment and a computer
- May have to manage several tasks at one time and may be interrupted frequently to meet the needs and requests of patients and other customers
- The environment may at times be busy, noisy and need excellent organizational, time and stress management skills to complete the required tasks
- A dynamic and compatible personality able to deal with customers and their demands at all levels
- Communication and interpersonal skills of the highest quality
Required minimum work experience
- 3 years experience in a similar environment
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 is 16 July 2021.
- 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.
- In accordance with our Employment Equity goals and plan, preference will be given to suitable applicants from designated groups as defined in the Employment Equity Act 55 of 1998 and subsequent amendments thereto.
Please note that AJ PERSONNEL is only responsible for the advertising of the advertisement on behalf of their client Wits Health Consortium.
AJ Personnel does not have any salary or other information regarding the position.
NB! This job is now closed. You can apply for other jobs by uploading your CV.
