Clinical Research Site Assistant

EXCELLENTIS-CLINICAL TRIAL CONSULTANTS AND SUPPORT SERVICES; George; On-site; ZAR 112,000 - 156,000; Full time

Job summary

Excellentis Clinical Trial Consultants invites applications for a Clinical Research Site Assistant (CRSA) on a 6-month full-time contract based at the George office. In-service training will be provided to enable execution of site functions, with potential renewal for a further fixed period.

Requirements include a National Senior Certificate, proficiency in English and Afrikaans, and strong Excel/Word skills.

Qualifications

• National Senior Certificate with strong passes in English and Mathematics or Mathematical Literacy.
• Ability to master GCP course and assist in trial execution, quality control, and planning.

Responsibilities

• Answer and route telephone enquiries professionally.
• Coordinate incoming and outgoing study shipments and documentation.
• Assist Management with day-to-day operational and administrative tasks.
• Contact participants to confirm and manage study appointments.
• Maintain effective communication among participants, staff, and Investigators.
• Schedule participant study visits according to protocol windows.
• Ensure GCP standards and trial duties are followed.
• Assist in maintaining regulatory and study documents and records.
• Coordinate logistics with departments and external entities.
• Procure supplies and manage lab samples and results.

Skills

Communication

Interpersonal skills

Attention to detail

Working under pressure

Education

National Senior Certificate (Matric / NQF Level 4)

Tools

Microsoft Excel

Microsoft Word

Job description

Excellentis Clinical Trial Consultants invites applications from suitably qualified candidates to fill a Clinical Research Site Assistant (CRSA) post on a 6-month full-time contract. Excellentis is an Independent Private Research Site executing multiple phase I–III clinical research studies in the Eden district and greater Karoo region. We are seeking an experienced, dynamic individual to work alongside the team in the clinical trial operations of multiple controlled randomised trials.

This position is based at our George office. In-service training will be provided to the successful candidate to enable the execution of functions as delegated at the research site. While the contract is initially for 6 months, there is a potential for renewal for a further fixed period.

Requirements

• Education: Minimum Requirement:National Senior Certificate (Matric / NQF Level 4) with strong passes in English and Mathematics or Mathematical Literacy.
• Core Aptitude: Ability to master a course of Good Clinical Practice (GCP) and assist in clinical trial execution, quality control, planning patient appointments according to protocol schedules, developing source data according to given protocols, and maintaining Investigator Site Files (ISF).
• Communication: Excellent communication and interpersonal skills.
• Core Skills: Meticulous attention to detail and the ability to work under pressure to meet tight timelines.
• Languages: Fluency in English and Afrikaans (both required).
• Technical: Fluency and advanced knowledge in Microsoft Excel and Word, with the ability to maintain spreadsheets/logs, design template planning tools, and independently develop source data documents.

Advantageous Attributes

• Clinical: SANC registration or equivalent clinical qualification.
• Highly Advantageous: A diploma or degree in a life sciences field (e.g., BSc in Biotechnology, Physiology, or Molecular Biology
• Certifications: Existing, valid GCP and Human Research Ethics certification.
• Experience: Prior experience or knowledge of clinical trial work in a clinical or administrative setting.
• Mobility: Valid driver’s license and access to a reliable personal vehicle.
• Exposure: Experience working in a public hospital setting, medical office, or previous clinical job-shadowing experience.
• Flexibility: Willingness and flexibility to focus on accomplishing tasks rather than working a fixed amount of hours.
• Commitment: Willingness to job-shadow at the site for a minimum of 10 hours prior to final confirmation of employment.

Responsibilities

Ensuring compliance with regulatory requirements, GCP, and Standard Operating Procedures (SOPs), you will work with a diverse clinical research team to help ensure projects are delivered within budget and on time. Your duties will include:

Administrative & Reception Operations

• Telephones: Answering the telephone professionally, routing calls, and handling enquiries efficiently.
• Couriers: Managing couriers, including coordinating incoming and outgoing study shipments and documentation.
• Office Support: Assisting Management with day-to-day operational, administrative, and ad-hoc office tasks to ensure smooth site operations.

Participant Coordination & Communication

• Appointments: Contacting participants directly to confirm, arrange, and manage study appointments.
• Liaison: Maintaining effective and ongoing communication among research participants, research staff, and Investigators during the study.
• Escalation: Ensuring any problems identified in the study are immediately brought to the attention of Excellentis management.
• Scheduling: Scheduling participant study visits accurately on the electronic diary according to protocol windows, Standard of Care (SoC) safety visits, and unscheduled visits as needed.
• Patient Contact: Handling ongoing telephonic contact with patients as required.

Trial Execution & Quality Compliance

• GCP Standards: Ensuring clinical research activities are performed in accordance with approved protocols and ICH/GCP guidelines.
• Trial Duties: Assisting with trial-related duties in accordance with Good Clinical Practice (GCP) standards.
• Quality Control: Assisting in data quality control checks and data verification.
• Inspections: Aiding the team in preparation for FDA/SAHPRA inspections and audits, as well as providing hands‑on assistance during these visits.

Document & Logistics Management

• Filing: Assisting in the maintenance of binders for all regulatory, safety, and study‑related documents, correspondence, and participant files.
• Meetings: Partaking in regular conference calls with the PIs and filing all communication documentation, including taking and filing minutes where delegated.
• Coordination: Coordinating logistics with various departments and external entities (e.g., pharmacy, laboratories, courier companies, research finance).
• Supplies: Identifying and ordering all supplies (e.g., laboratory kits) needed for studies, ensuring they are available and within their expiration dates.
• Lab Samples: Assisting in biological sample processing and managing specimens and results via commercial or local laboratories.
• Real‑time Tracking: Following up on laboratory or other investigative results in real time, ensuring they are reported to Investigators and the clinical team immediately so necessary follow‑up steps can be taken.