The Assistant Site Manager plays a key part in providing both operational and leadership support at the site by leading, developing, and supporting the site’s staff, fostering a collaborative and high-performing team environment. The role is critical to ensuring the successful execution of clinical trials by overseeing patient care, protocol adherence and quality documentation and processes.
Key Performance Areas (KPAs) & Responsibilities include, but not limited to:
Leadership & Staff Management:
- Provide day-to-day leadership and guidance to Study Coordinators and Research Nurses, fostering a culture of accountability, teamwork, and continuous improvement.
- Ensure that all staff are fully trained, supported, and engaged to meet the site’s operational and clinical goals.
- Assist the Site Manager in coaching and mentoring staff, ensuring performance standards are met, and addressing any personnel challenges that may arise.
- Coordinate and schedule the clinical team to ensure sufficient coverage during patient visits and study procedures and help with the recruitment and onboarding of new staff.
Study Preparation & Site Readiness:
- Lead the planning and preparation for new studies, including developing and approving source documents and ensuring site readiness with appropriate clinical consumables, equipment, and files in place.
- Coordinate across teams to ensure seamless study start-up.
- Oversee the informed consent process, working closely with the investigator to ensure participants are fully informed, given adequate time for questions, and that consent forms are signed and processed with accuracy.
- Ensure compliance through routine quality checks on all ICFs.
Protocol Compliance & Participant Care:
- Work with staff to ensure that all inclusion/exclusion criteria are verified before randomization and that all referrals are consented and screened within the permitted screening window.
- Ensure optimal participant care, with staff following protocol-correct procedures in a timely and accurate manner to prioritize safety, ensuring that delegated tasks are appropriately carried out by team members.
- Participate in the development of Corrective and Preventive Actions (CAPA) to address any site issues or deviations.
Monitoring & Query Resolution:
- Oversee the maintenance of up-to-date site files and documentation, proactively address site monitoring queries, lead the team in resolving system-generated queries and support the timely and accurate entry of clinical trial data into electronic databases (e.g., EDC systems).
- Collaborate with the Clinical Research Associate (CRA) during site monitoring and exit meetings.
- Support study coordinators in study management, audit preparation, and resolving queries.
- Actively engage with staff to streamline processes and ensure a cohesive approach to study execution.
Sample Processing & Operational Support:
- Provide leadership and support to the Sample Processing Room staff, ensuring smooth workflows and adherence to sampling protocols.
- Assist the Site Manager in operational tasks, helping ensure compliance with site-level Quality Management Systems (QMS).
Training & Development:
- Lead training efforts, organize site meetings, and provide ongoing coaching to ensure that staff are aligned with study protocols and operational standards.
- Cultivate an environment of continuous learning and professional development.
- Perform additional leadership and operational duties as assigned to ensure the smooth running of the clinical research site.
Minimum Requirements:
- Valid Nursing Council certificate (SANC) or any other professional certification related to qualification.
- Valid SA and ICH GCP certificate.
- Supervisory/management experience would be an advantage.
- Minimum 2 years’ Clinical trial experience; Candidates with experience in clinical trials would be given preference.
- Computer literacy – ability to use Word, PowerPoint and Excel at intermediate Level.
- Valid Driver’s License.
- Flexibility to help out at other TASK sites and to accommodate occasional night shift and regular weekend schedules.
Key Personal Inherent Characteristics:
- Excellent communication skills and interpersonal skills.
- Good leadership skills and ability to motivate and lead a team by example.
- Problem-solving skills.
- Able to adapt and respond based on operational requirements.
- High attention to detail.
- Excellent follow-up skills.
- Excellent planning & organizing skills.
- Team player.
- Professionalism.
- Accountability.
- Efficient and effective under pressure.
Details:
Contract Type: Permanent
Applications Close: 15 November 2024
Please indicate in your application that you are applying for the above-mentioned position.
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