Study Coordinator

6 months ago

Johannesburg, South Africa AJ Personnel Full time

**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**:

- **32 Princess of Wales Terrace, Parktown/17 Eaton Road/Charlotte Maxeke Johannesburg Academic Hospital/ Chris Hani Baragwanath Academic Hospital, Soweto**

**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 ICFs, 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., eCRFs, CRFs)
- 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**:

- **Professional Nursing Diploma with a Diploma in Oncology**:

- **Recent Good Clinical Practice (GCP) and IATA Certification required**

**Required minimum work experience**:

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

**Professional body registration**:

- Registered with the South African Nursing Council (SANC)

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

- Good communication skills both written and verbal
- Thorough with good attention to detail
- Must be computer proficient to manage online study systems
- Must be able to process and ship study-related lab samples
- Phlebotomy skills and the ability to perform an ECG are necessary
- 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 may and traveling will be required from time to time
- Light physical activity is 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.

**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.

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