Regulatory Assistant Task Headquarters

4 days ago

Cape Town, South Africa TASK Full time

**Overall Purpose of the Position**:
The Regulatory Assistant will be responsible for assisting with, and performing the regulatory clinical trial administrative functions efficiently, ensuring that all regulatory documentation is current and in compliance with Good Clinical Practice (GCP) and regulatory guidelines.

**Key Performance Areas (KPAs) & Responsibilities include, but not limited to**:

- Preparing, tracking and maintaining all initial and follow up correspondence and regulatory documentation required by local regulatory authorities and ethics committees.
- Ensuring compliance with ongoing reporting requirements to local regulatory authorities and Ethics Committees.
- Preparing, collating and updating documents accurately for submissions.
- Successful submissions of new protocols to regulatory authorities and Ethics Committees for approval.
- Maintaining submission timelines and striving for quickest Turn-Around-time possible without compromising accuracy and quality
- Assisting with Informed Consent Forms (ICF) reviewing, changing, and translating where applicable.
- Managing queries / issues following submissions by redirecting and following up on the responses.
- Liaising effectively with team members.
- Liaising effectively with Sponsor / Sponsor representatives
- Demonstrating initiative where shortcomings or issues are noted to improve or correct shortcomings after liaising with the Regulatory team.
- Reporting inconsistencies to Management
- Quality checking and coordinating documents for satellite and multi-site submissions.
- Managing submissions for satellite and muti-sites.
- Maintaining good communication and relationships with all team members
- Communicating and updating study team regularly on progress of submissions
- Coordinating and submitting annual re-approvals, progress reports, amendments, safety reports and unanticipated problem / noncompliance reports etc. in a timely and accurate manner
- Notifying the Quality Assurance (QA) team of all approvals as required (Protocol and ICF amendments, additional staff, etc.)
- Filing and Administrative duties
- Setting up Investigator Site Files for internal studies.
- Collecting, sharing and providing documents for filing in the Investigator Site File (ISF) as appropriate
- Sharing documents with sponsor / sponsor representative for Trial Master File
- Providing support with administrative and regulatory tasks.
- Overseeing and managing the maintenance of ISFs across studies
- Overseeing and managing the preparation of ISFs for Monitor visits.
- Delegating / coordinating actioned Items issued by monitor post Study Monitoring Visit.
- Coordinating and controlling the distribution of new / amended documents and recalling or superseding previous versions.
- Completing and maintaining trackers for documents where applicable.
- Assisting with preparation for Audits and / or Monitor visits.
- Coordinating Work files and other documents needed for SIVs and site operations such as logs (compiling, updating, distribution and superseding).
- Coordinating and controlling the distribution of all confidential study documentation and essential documents.
- Designing protocol specific logs.
- Coordinating stationary supplies and orders.
- Coordinating / arranging / overseeing the courier arrangements of documents.
- Coordinating the archiving process and assisting with the packing and labelling of boxes.
- Attending to and investigating invoice queries.
- Attending meetings and recording minutes
- Ensuring that the regulatory server and shared file platforms are current and organized in a manner that enables other team members to have access to documents and templates.
- Performing miscellaneous job-related duties as assigned.
- Performing admin, support and start up duties as assigned.

**Ideal Requirements**
- Matric
- Previous experience in clinical trials / regulatory and / or quality assurance (Advantageous)
- Effective administrative skills
- Valid GCP certificate (preferred)
- Computer proficiency in Microsoft Word, Excel and Outlook (Essential)

**Key Personal Inherent Characteristics**
- Attention to detail
- Accurate and methodical
- Ability to meet deadlines.
- Good communication skills
- Administrative Skills
- Functions well in a team.

**Details**:
**Area**:Parow, Cape Town

**Contract Type**: 18 Months Fixed Term

**Applications Close**: 10 January 2025 **(16:00)**

TASK reserves the right to withdraw this advertisement and not fill the above-mentioned vacancy at any stage during the recruitment process.

Meeting our employment equity goals will be acknowledged during the recruitment process.

**Job Types**: Full-time, Temporary
Contract length: 18 months

Application Question(s):

- What is your notice period?
- What are your gross salary expectations?

Application Deadline: 2025/01/10

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