Clinical Trial Assistant

1 week ago

Johannesburg, South Africa Johnson & Johnson Full time

**CLINICAL TRIAL ASSISTANT**

**Location: Gauteng**

**Contract: Permanent**

**Position Summary**

The Clinical Trial Assistant II (CTA II) supports the Local Trial Manager (LTM) and/or Site Manager (SM) to ensure optimal management of all documents with logístical and administrative tasks related to trial startup, execution and closing of clinical trials. Ensures trial related activities are compliant with GCO SOPs, policies and local regulatory requirements. May contribute to process improvement, training and mentoring of other CTAs.

**The responsibilities & the impact YOU will have**:
**The main duties and responsibilities of the position are**:

- Provide administrative and logístical support to LTM and/or SM in tracking progress of the trial, management of study data, budget, organizing meetings, mailing and correspondence, materials, drug distribution and other relevant tasks as appropriate in adherence to relevant SOPs, policies and local regulatory requirements.
- Supports the local study team in performing site feasibility and/or country feasibility.
- Maintains information in relevant systems.
- Ensures current versions of the required trial documents, trial-related materials and supplies are provided to the investigational site within required timeframes, as applicable.
- Support LTM and/or SM in collecting/preparing documents required for study start-up/submission to IEC/IRB and/or HA.
- Support LTM and/or SM in collecting, processing and archiving study related documents as appropriate. Use appropriate systems to ensure file completeness at designated study milestones.
- May assist LTM in conducting local investigator meeting or with making arrangements for the investigators participating in an international meeting.
- Maintains and updates contact information in relevant systems to ensure appropriate safety updates distribution.
- Comply with all training requirements
- Ensure inspection readiness at all times.
- May contribute to process improvement including, but not limited, to representing functional area in process initiatives and contribute to optimization of daily processes.
- May be assigned as a coach and mentor to a less experienced CTA.

**Principal Relationships**:
Primary Reporting Structure: Reports to Functional Manager (FM).

Primary interfaces: FM, LTM and SM(s) for assigned clinical studies.

Other Internal Interfaces: R&D Country Head, Clinical Trial Manager (CTM), LTM, SM, Quality & Compliance Manager/Specialist, Contracts & Grants, Clinical Trial Assistant team, Medical Affairs.

External Interfaces: Investigators and their delegates at site.

**Qualifications** We’d love to hear from YOU, if you have**:

- A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required.
- Proficient in English language. Strong knowledge with MS Office (Word, Excel, Access, Outlook, Explorer and PowerPoint). Strong interpersonal and negotiating skills preferred. Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment. Perform activities in a timely and accurate manner.

**_For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. _**

**_We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences_**

**_That is why we in South Africa are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are. _**

**_Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong” _**

**Primary Location**
South Africa-Gauteng-Johannesburg
- **Organization**
Janssen Pharmaceutica (Pty.) Ltd. (8490)

**Job Function**
R&D

**Requisition ID**
2206034989W

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