Study Coordinator

**Main purpose of the job**:

- To administer, maintain, and coordinate clinical trials according to good clinical practice, the study protocol, and the site standard operating procedures
- Act as a pivotal point of contact for the clinical trial team and the study sponsor(s)

**Location**:

- **WCR Parktown - Johannesburg**

**Key performance areas**:

- Study Management -:_
- Primary SSC on trial to oversee all operations on trial, ensure protocol and GCP compliance
- Attend Investigator meetings, SIV, and any other in-person or virtual training to manage the study
- Assist study team with efficient study start-up, conduct, and close-out
- Ensure access to online portals for self and support staff
- Manage regulatory updates throughout the study (New ICF’s, Protocol Amendments, etc)
- Manage site monitor visits according to GCP and Site SOP
- Proactively resolve protocol queries and missing data with Investigators and Clinical Trials Assistants
- Communicate with CRO, Sponsor, and regulatory authorities regarding notifiable trial events
- Participant Management -:_
- Prepare for and manage participant visits and data capturing in line with protocol and site SOPs
- Assist in patient recruitment, screening, and enrolment of eligible patients according to protocol requirements
- Perform and/or book procedures correctly per protocol within the scope of practice
- Manage lab kits and study samples according to protocol, procedures manual, and local legislature
- Administer study medication safely in line with the scope of practice
- Be able to manage medical emergencies within the scope of practice
- Communicate well with investigators regarding participant welfare while on study
- Notify relevant parties of Serious Adverse Events or Events of Medical Importance within 24 hours
- Quality control of patient files and data entries (i.e., eCRF’s, CRF’s)
- Teamwork & Support -:_
- Assist team members with an open helpful attitude, perform on-the-job training where necessary
- Assist the Pharmacist with visit activities (IVRS, IP management, etc.)
- Assist the administrative staff with arrangements to be made for participant visits (Patient transport with Uber, Vendor booking details, etc.)
- Assist site finance staff with payments on the study (pass-through, travel fees, etc.)
- Assist the team with ad hoc assignments and duties as needed, delegated by the line manager and within the scope of practice

**Required minimum education and training**:

- **Nursing Diploma (or equivalent)**:

- **Formal Oncology training is required**:

- **Certification in Project Management and good clinical practice (GCP) will be an advantage**

**Professional body registration**:

- Registration with SANC/HPCSA

**Required minimum work experience**:

- **Minimum 2 years experience in a clinical trial environment**

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

- Thorough with good attention to detail
- Ordered and systematic in approach to tasks, with strict compliance to protocols
- Exceptional organizational and administrative skills are required together with working knowledge of Microsoft Office
- Able to exercise discretion and independent decision-making
- Ability to prioritize own workload, take initiative (pro-active), and work to tight deadlines
- Self-motivated with high regard for work ethic, values, and integrity
- Overtime and traveling will be required from time to time
- Light physical activity required

**TO APPLY**:

- Only if you do meet the minimum job requirements and experience as mentioned above, you may submit a detailed updated CV.
- _AJ Personnel is fully POPIA Compliant._
- Please take note that the applicants who do not adhere to the above criteria will not be considered for the respective position.
- 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.
- AJ Personnel does not have any salary or other information regarding the position.