Study Coordinator

3 weeks ago

Johannesburg, South Africa AJ Personnel Full time

**Main purpose of the job**:
To assist the Project Head and study team by coordinating the procedures and daily activities within the study, according to the approved protocol, GCP and sponsor requirements

**Location**:
PHRU - Chris Hani Baragwanath Academic Hospital, Soweto

**Key performance areas**:

- Assist with participant visits in the clinic as needed
- Review Case report forms and source documentation on a daily basis to ensure the forms are completed correctly before the participant leaves the clinic.
- Perform internal quality control checks of completed data by means of checking and completing the data clarification forms submitted by the laboratory.
- Perform internal quality control checks as per approved CRS clinical quality management plan by the sponsor. Ensure that team members are given feedback on internal and external monitoring findings to prevent the mistakes from reoccurring dependent on the finding from the audit which can range from immediately to the maximum of three days.
- Provide routine training to staff including training on areas identified as problem areas.
- Assist in preparation for internal and external monitoring visits, audits, and resolution of queries.
- Assist in drafting and reviewing SOP’s and Work Practice documents as needed.
- Generate reports detailing visit schedules for the clinician’s project head, and CRS leader on a weekly basis.
- Capture Data electronically as stipulated by the protocol.
- Review of participants files on a daily basis and per CQMP.
- Oversee the ordering of kits and other equipment/items needed for the studies.
- Schedule training pertaining to the protocol adherence.
- Training pertaining to Case Report Form completion.
- Training regarding the completion of source documents.
- Training based on audit findings or trends regarding the completion of Case Report forms and source documentation.
- Oversee research nurses, administrators, recruiters and counsellors.
- Schedule and plan annual leave to be taken in conjunction with the employee and Project Head.
- Up skill the staff by providing on the job training.
- Manage the departments manpower as and when necessary.
- Take ownership and accountability for tasks & activities and demonstrates effective self-management.
- Follow through to ensure that quality and productivity standards of own work are consistently and accurately maintained.
- Inform relevant parties including project head and CRS leader in the event of tasks or deadlines not met and provides appropriate means of resolution
- Support and drives the business’ core values
- Maintain a positive attitude - Respond openly to feedback - Take ownership for own career development - Manage colleagues and client’s expectation and communicate appropriately.
- Willing to help others and go the extra mile to meet team targets and objectives.
- Manage own disruptive emotions (handle stress in ways that do not negatively impact on the team).
- Ability to coach, guide and mentor the staff.
- Ability to assist and support all the staff in the different departments within the syndicate i.e., recruitment, counsel, enrolment, retention, data and clinical administration.
- Patient consultations as and when required.
- Phlebotomy as and when required.

**Required minimum education and training**:

- **Grade 12.**:

- **Nursing Diploma or equivalent.**

**Professional body registration**:

- **South African Nursing Council or any other relevant**

**Required minimum work experience**:

- **3 years’ experience in a research environment.**:

- **Computer Literate at an intermediate level.**

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

- Good Clinical Practice.
- ABC Quality Control.
- Attention to detail.
- Interpersonal skills.
- Self-disciplined and organized.
- Time Management.
- Project management.
- Team Player.
- Assertive.
- Logical thinker.
- Analytical ability.
- Enthusiasm.
- Proactive.
- Innovative.
- Presentation skills.
- Ability to work independently.

**TO APPLY**:

- 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.**:

- **The organisation maintains a Mandatory Covid-19 requirement and as such only Covid-19 Vaccinated incumbents will be considered for positions.**

**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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