Study Coordinator

**Main purpose of the job**:

- To administer, maintain and coordinate the logístical aspects of clinical trials according to good clinical practice, the study protocol, and the standard operating procedures and to act as a pivotal point of contact for the clinical trial team and the donors

**Location**:

- **Wits RHI -7 Esselen Street, Hillbrow, Johannesburg**:

- **Research Centre, **On the 3rd, 4th, and 5th Floor**

**Key performance areas**:

- Assess the project activities and external developments within the field to improve outputs on an ongoing basis
- Develop/Review the work plan and other strategic project documents for the effective implementation of the project
- Work with colleagues to enhance project goals and outputs
- Identify the needs of the relevant project
- Identify and get the resources required
- Coordinate with external agencies such as public health and NGO partners, regulatory bodies, donor monitoring and auditing agencies, and others as necessary
- Develop & manage participant/beneficiary recruitment & retention strategies
- Support the development of data management monitoring and evaluation plans
- Develop and maintain project information systems
- Develop project tools such as SOPs, informed consents, participant/beneficiary information materials, technical guidelines, best practice documents, and other documents as required
- Coordinate and troubleshoot operational activities such as laboratory activities, pharmacy, IT, procurement, etc.
- Conduct training on project processes and activities
- Write project reports for internal/external dissemination
- Present papers and results to stakeholders
- Attend to all staffing requirements and administration
- Supervise and manage the duties of subordinates to ensure optimal staff utilization and maintenance of sound labor relations
- Perform and facilitate performance development and assessments through individual coaching and other support mechanisms
- Identify substandard performance by team members and take necessary corrective action
- Coach and train subordinates and team members to ensure the acquisition of knowledge and skills required by the organization
- Promote harmony, teamwork, and sharing of information
- Comply with Good Clinical Practice (GCP), Protocol requirements, and Standard Operating Procedures (SOPs)
- Verify the accuracy of data in source documentation and accuracy of transcription from source data to Case Report Forms (CRF) as needed
- Ensure errors on source documents e.g., CRFs are corrected, initialed, and dated (as needed)
- Support the timely transmission/data faxing of relevant Case Report Forms following QC activity (as needed)
- Ensure completion of corrective action of internal and external QC reports and monitoring reviews
- Assist with staff training (and retraining) where error trends are identified
- Prepare files for monitoring visits and requirements
- Meet with Monitors as and when required
- Take ownership and accountability for tasks and demonstrate effective self-management
- Follow through to ensure that quality and productivity standards of own work are consistently and accurately maintained
- Maintain a positive attitude and respond openly to feedback
- Take ownership of driving your own career development by participating in ongoing training and development activities such as workshops, forums, conferences, etc.
- Participate and give input in ad hoc projects and initiatives

**Required minimum education and training**:

- **Relevant Masters Degree**:

- **A valid driver’s license**:

- **Proficiency in MS Office**

**Required minimum work experience**:

- **Minimum 2-3 years of clinical trial experience**

**Professional Body registration**:

- Dependent on Project

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

- Working experience in a medical research environment
- Experience in project management
- Able to work independently and as part of a multi-disciplinary team
- Thorough with good attention to detail
- Ordered and systematic in approach to tasks, with strict compliance to protocols
- Exceptional organizational and administrative skills with working knowledge of Microsoft Office
- Able to exercise discretion and independent decision-making
- Able to prioritize own workload, take initiative (pro-active) and work to tight deadlines
- Self-motivated with high regard for work ethic, values, and integrity
- Good communication skills
- Display concern for patients and willingness to respond to patients’ needs and requirements

**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 applicant