Study Coordinator

Task Applied Science; Pretoria; On-site; ZAR 200 000 - 300 000; Full time

Job summary

A leading clinical research institute is seeking a Study Coordinator in Pretoria to manage clinical trials, ensure compliance with protocols, and facilitate participant recruitment. The ideal candidate holds a Nursing degree, has prior trial experience, and excels in communication and organizational skills. This is a full-time position for a fixed term of 12 months, offering significant opportunities to impact clinical research quality and participant welfare.

Qualifications

• Professional use of the English language: both written and verbal.
• Previous experience in clinical trials, preferably in a coordinator or similar role.
• Strong understanding of Good Clinical Practice (GCP) guidelines.

Responsibilities

• Ensure strict adherence to study protocols and participant safety.
• Collaborate with recruitment teams to identify potential participants.
• Maintain accurate study documentation and compliance checks.

Skills

Attention to detail

Effective communication

Organizational skills

Administrative skills

Team collaboration

Education

Nursing tertiary Diploma or bachelor's degree

Valid SANC certificate

Tools

Clinical trial management systems (CTMS)

Electronic data capture (EDC) systems

MS Word

MS PowerPoint

MS Excel

Job description

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

A study coordinator plays a pivotal role in the execution and management of clinical trials conducted at the research site.

Key Performance Areas (KPAs) & Responsibilities

The position needs to acquire in-depth knowledge of relevant study protocols and will be responsible for coordinating various aspects of the clinical trial process to ensure compliance with regulatory standards, protocol requirements, and quality standards across the major aspects of clinical research including study management, data collection, participant care, participant advocacy and recruitment.

This role demands meticulous attention to detail, excellent organizational skills, and effective communication abilities to facilitate seamless collaboration among research team members, sponsors, and participants.

Responsibilities

Protocol adherence: Ensuring strict adherence to study protocols, regulatory guidelines, ethical and good clinical practice guidelines as well as TASK standard operating procedures (SOPs) whilst ensuring participant safety throughout the conduct of the clinical trial.

Assisting (Deputy / Assistant) Site Manager in preparing for study setup / start.

Participant Recruitment and Screening: Collaborating with the recruitment team to set up recruitment plan and identify potential participants according to study eligibility criteria. Screening of potential participants according protocol guidelines and eligibility criteria. Maintaining accurate participant records and ensuring informed consent procedures are followed.

Study Documentation: Performing the preparation, maintenance, quality checks and completion of study documentation, including source and case report forms (CRFs), and study logs. Maintaining accurate study documentation according to good clinical practice (GCP) and ensuring compliance with regulatory requirements and ethical guidelines. Performing electronic data capturing and validation. Preparing, coordinating, and facilitating audits and inspections.

Clinical Trial Conduct: Assisting the investigators in all aspects of study management and according to delegation and training. Coordinating, tracking and performing clinical trial activities, including scheduling study preparation, set-up and readiness, participant visits, performing study procedures according to scope, relevant compliance checks, quality and timely data collection and entry. Maintaining an adequate supply of study laboratory kits and consumables and supporting sample processing staff in various functions such as processing and shipping samples, while ensuring good documentation practices.

Educating participants on study related requirements and compliance. Familiarizing themselves with terminology (protocol and medical), normal ranges applicable to procedures in order to identify and report values and observations that fall out of normal range.

Maintaining accurate and complete records of protocol deviations and share regularly with Principal Investigator and Assistant Site Manager. Ensuring Investigator Site Files are updated and maintained continuously with up-to-date and complete study and essential documentation. Overseeing quality control for the specific study to ensure data integrity, protocol compliance and completion.

Communication and Collaboration: Serving as the primary point of study contact for communication between sponsor, sponsor representative and other internal and external stakeholders. Attending to and facilitating meetings to review progress, address challenges, and implement corrective actions as needed.

Quality Assurance: Working with the quality teams to implement quality control measures to ensure data integrity, protocol compliance, and participant safety throughout the study. Implementing internal quality assurance measures to ensure GCP compliance, quality data collection and participant safety. Conducting regular quality checks and addressing deviations or discrepancies promptly. Addressing and responding to queries from sponsor representatives in an effective and timely manner.

Training and Development: Acquiring and completing protocol specific training and assisting investigators by coordinating training to the rest of the study team in a timely manner. Staying up to date on relevant guidelines, regulations, and industry trends through continuous education and training.

General: Assisting with and performs all duties within reasonable scope.

Ideal Requirements

• Nursing tertiary Diploma or bachelor's degree (Professional Nurse)
• Valid SANC certificate
• Previous experience in clinical trials, preferably in a coordinator or similar role
• Strong understanding of Good Clinical Practice (GCP) guidelines and other relevant regulatory requirements
• Professional use of the English language: both written and verbal
• Strong administrative skills
• Proficient in utilising various software systems, including clinical trial management systems (CTMS), electronic data capture (EDC) systems, and other relevant applications
• Computer literacy – Ability to use Word, PowerPoint and Excel at intermediate level
• Flexibility to work at other TASK sites and to accommodate occasional night and weekend work (TASK Brooklyn Primary site)

Key Personal Inherent Characteristics

• Excellent organizational skills with the ability to prioritize tasks and manage multiple responsibilities simultaneously
• Effective communication and interpersonal skills, with the ability to collaborate effectively with diverse stakeholders
• Attention to detail and a commitment to maintaining high standards of quality and compliance
• Functions well independently as well as in a team
• Initiative
• Self‑driven

Details

• Area: Brooklyn, Cape Town
• Contract Type: 12 Months Fixed Term
• Applications Close: 15 August

Applications & Process

Job Types: Full-time, Temporary

Contract Length: 12 months

Application Question(s): What are your monthly gross salary expectations (before deductions)?

Application Questions

• Where is your notice period?
• Do you have a Nursing qualification (Professional Nurse)?
• Do you have a valid SANC certificate?

Work Location

In person