Regulatory & Study Start-up Coordinator Task Headquarters

**About the Company**:
TASK is a South African headquartered, multinational clinical research institute that conducts clinical trials to determine the treatment effects of novel medicinal products or devices in healthcare and offers services in conducting complex clinical trials in a wide variety of therapeutic areas.

**Overall Purpose of the Position**:
The overall purpose of the role is to ensure the successful initiation of clinical trials in an efficient and timely manner, reducing timeframe from study approval to initiation and coordinating and performing regulatory activities to ensure compliance with Regulatory and Ethical guidelines.

The role coordinates study start-up (SSU) activities and serves as the primary start-up contact for investigators and research sites coordinating and actioning all communication responsibilities with RA, IEC and other local provincial regulators from start up to archiving and filing of final study report according to applicable local and/or international regulations, whilst meeting study timelines.

**Key Performance Areas (KPA’s) & Responsibilities include, but not limited to**:

- Coordinating and facilitating the start-up activities and executing study start-up for assigned protocols within timelines by identifying clinical team needs at the site and in line with contractual agreements, contracting, delegating, and managing tasks and tracking critical timelines i.e., clinical trial insurance expiry dates, export permit dates etc.
- Setting up and managing a project plan and timeline per study, communicating, and troubleshooting the leading and lagging indicators to meet site initiation readiness at the investigator meeting / site initiation visit
- Serving as a liaison between the research site and regulatory authorities, sponsors, and other stakeholders
- Communicating effectively with internal and external teams to ensure alignment on study start-up timelines and requirements
- Collaborating with investigators, sponsors, and vendors to obtain necessary documentation for study start-up
- Monitoring yearly updates and notifications on projects to remain current and compliant
- Providing logístical support of clinical trial supply coordination, where applicable
- Ensuring that all start up information & requirements are kept up to date in a central repository, maintaining the tracking of project metrics with a SSU tracker and providing regular status updates to teams involved
- Participating in general feasibility activities from funders and sponsors, protocol and study manual reviews when required, interacting with ethics committees and regulatory authorities and / or dealing with investigator contracts, budgets, material transfer agreements, export permits, site indemnities and / or insurance coverage for various clinical trials and tracking of these documents
- Effective vendor set-up, management, and oversight to ensure timely activation, compliance with study requirements, and quality deliverables across all studies.
- Accurately preparing, submitting, and maintaining regulatory documents for ethics committees and regulatory agencies
- Maintaining up to date knowledge in regulations and changes, ensuring adherence and compliance with local and international regulatory requirements, clinical guidelines, policies and associated documentation
- Tracking and managing essential documents required for regulatory submissions and audits
- Assisting in the development and maintenance of site-specific standard operating procedures (SOPs), policies and Working Documents as needed
- Assisting in the development and implementation of quality assurance processes related to regulatory compliance and study start-up
- Following standard processes and regulations for the collection, processing and submission of study site documents / essential documents and site information for successful submissions adhering to timelines
- Receiving and coordinating RA and IEC responses/comments until final feedback e.g., approval
- Communicating throughout the life cycle of the trial with RA, IEC, provincial bodies as per their guidelines
- Attending team and operational team meetings and provide updates
- Mentoring junior staff members to improve quality of outcomes and to maintain team morale if and when required
- Performing investigator site file (ISF) reviews.
- Working closely with the QA / REG team and assisting in conducting internal QA audits and / or assisting with sponsor audits and regulatory inspections
- Performing any other tasks as may be required from time to time
- Coordinating archiving process with vendor and site teams

**Ideal Requirements**
- Bachelor’s degree, or equivalent qualification or work experience, in a scientific, pharmaceutical or healthcare discipline or related field
- 2+ years’ previous clinical trial / regulatory / quality assurance experience will take preference
- Project Management experience / certificate (Advantageous)
- Valid GCP certificate / previ