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**

**Key performance areas**:

- Assess the project activities and external developments within the field in order 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 tertiary qualification**:

- **A valid driver’s license**:

- **Proficiency in MS Office**

**Required minimum work experience**:

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

**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 patient's 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 applicants from designated groups as defined in the Employment Equity Act 55 of 1998 and subsequent amendments