Clinical Research Associate

**Main purpose of the job**:

- As a Clinical Research Associate, you will lead the team in conducting a detailed Quality Control of all internal processes related to clinical trials, to ensure the successful execution and compliance with regulatory requirements
- You will then work with the team to further optimize and implement Quality Assurance processes to ensure continued execution of laboratory excellence for Clinical Trials

**Location**:

- **Wits DIH - Braamfontein, Johannesburg**

**Key performance areas**:

- In conjunction with the site PI(s), carry out QC of internal processes related to clinical trials to enhance understanding of QC principles and use of effective QC methodologies, tools, and systems
- Conduct and document a detailed Quality Control of all internal processes related to Clinical Trials at the laboratory
- File monitoring to ensure compliance with study protocols, regulations, and Good Clinical Practice (GCP) guidelines
- Review of internal laboratory processes, including specimen storage
- Identify internal communication gaps and other related activities that may adversely affect optimized processes
- Optimize and implement Quality Assurance processes that are robust, well-defined, and followed consistently to deliver services that meet or exceed customer requirements
- Provide regular updates to the Director of Laboratories
- Compile a report of activities conducted, potential gaps, and steps that have been taken to strengthen internal processes
- Establish best practices to ensure compliance with approved QC/QA protocols
- Work with study teams to further optimize and implement Quality Assurance processes to ensure continued execution of laboratory excellence for Clinical Trials
- Monitor and evaluate overall progress on the achievement of results as well as the sustainability of the project results and report periodically to the project management team
- Review patient records from relative programs for appropriate clinical data
- Check patient records for fraudulent activity, clinical malpractice and/or unethical practice
- Check patient records to ensure adequate history-taking, management, and reporting of patients
- Participate in QC/QA activities mandated by the Director of Laboratories
- Compiling Clinical Compliance Reports
- Providing clinical advice on various QC/QA compliance audits
- Support clinical file reviews and audits to identify skills gaps
- Regularly review compliance results from studies to identify gaps
- Provide clinical advice to address skills gaps
- Recommend new policies or the amendment of current policies
- Interacting with multiple stakeholders of the Division
- Establish and maintain effective working relationships with key external partners
- Establish and maintain effective working relationships with key internal role players
- Liaise with internal departments/units in the coordination of services for the outputs/key deliverables for the program
- Maintain existing relationships between the Division, stakeholders and WHC

**Required minimum education and training**:

- **Bachelor's Degree in Life Sciences or a related field**:

- **Advanced Degree preferred**

**Required minimum work experience**:

- **Minimum of 10 years of experience as a Clinical Research Associate, with a significant portion in a senior or leadership capacity**:

- **Certification as a Clinical Research Professional (CCRP) or equivalent is desirable**

**Desirable additional education, work experience, and personal abilities**:

- Process orientation with impeccable attention to detail
- Passion to positively promote and drive success in company initiatives
- In-depth knowledge of clinical research regulations, guidelines, and GCP
- Strong understanding of clinical trial processes, including site selection, study start-up, monitoring, and closeout activities
- Proven track record of successfully managing multiple clinical trials simultaneously, meeting project timelines, and ensuring data quality
- Excellent communication, interpersonal, and organizational skills, with the ability to build effective relationships with stakeholders
- Proficiency in using clinical trial management systems, electronic data capture systems, and other relevant software
- Ability to work independently, prioritize tasks, and adapt to changing project demands
- Attention to detail, critical thinking, and problem-solving abilities

**TO APPLY**:

- Only if you do meet the minimum job requirements and experience as mentioned above, you may submit a detailed updated CV.
- Please take note that the applicants who do not adhere to the above criteria will not be considered for the respective position.
- 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 i