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 logistical 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 / previously attended GCP
• Valid Driver’s license
Key Personal Inherent Characteristics
• Excellent communication (written and verbal)
• Detail-oriented individual with strong organizational and communication skills
• To work collaboratively with cross-functional teams, vendors and or stakeholders in order to achieve objectives
• Excellent problem-solving, analytical, pro-active and critical thinking skills
• Able to manage confidential information with discretion and be able to work on several projects at the same time with high flexibility and detail oriented.
• Confident
• Multi-tasking and be able to work on several projects at the same time with high flexibility and detail oriented.
• Self-motivated, with the ability to effectively manage time and prioritize workload
• Team player
• Able to work, excel and manage competing priorities within a fast-paced dynamic, stressful and constantly changing work environment.
• Willing to travel
If you have not heard from us within one month, please consider your application as unsuccessful.
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.
By responding to this advert and sending your cv, cover letter and/or any other documentation, you are consenting to TASK processing your personal information as contained in the furnished documents. TASK may process your personal information for recruitment purposes for suitable posts that may arise within the organisation. You agree that you have familiarised yourself with South Africa’s Protection of Personal Information Act and understand your rights and obligations under this Act.
