Study Coordinator

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. 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 as well as performing 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. Specific duties and requirements may vary depending on the study protocol and site structure.

The purpose of the Assistant Site Manager is to ensure that clinical trials are conducted according to protocol requirements at all times ensuring all procedures are documented in source and data is accurately transcribed onto clinical research forms (CRF) or electronic-CRF's. In addition, this role supports the site Manager by performing various staff and study management and administrative functions and ensure that the site is managed to function optimally supporting the company's strategic goals and service delivery.

Key Performance Areas (KPAs) & Responsibilities include, but not limited to:

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 the 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, conducting participant visits, performing study procedures according to scope, relevant compliancy checks, quality and timely data collection and entry
• Maintaining an adequate supply of study supplies and consumables
• 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
• Familiarising themselves with terminology (protocol and medical), normal ranges applying to procedures to be able to identify and report values and observations that fall out of normal range
• Maintaining accurate and complete records of protocol deviations and sharing regularly with Principal Investigator and 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 performing all duties with-in reasonable scope

Assistant Site Manager

• Planning for new studies to ensure site readiness, including creating and maintaining source documents aligned with study database/eCRF and ensure approval before study start, preparing files and ensuring clinical consumables and equipment are available for study start
• Assisting the investigator in signing and processing the informed consent form(s)(ICFs) and ensuring that adequate time and privacy for reflection and answering questions has been provided. Performing quality check on ICFs.
• Assisting the investigator in verifying whether all inclusion and exclusion criteria are met before randomization
• Ensuring site referrals are consented and screened within allowed screening period
• Ensuring optimal participant preparation, care and safety at all times for all subject visits
• Performing study specific procedures in a protocol-correct manner, within given timelines and in specified order, with the assistance of pre-drafted prompt sheets
• Ensuring participant safety, protocol compliance and always prevent protocol deviations
• Familiarising self with normal ranges in vital signs, ECG measurements, safety blood ranges, to identify abnormalities and act/document accordingly to ensure subject safety
• Ensuring the site files are always updated with latest study documentation at study start, during the study and at study close out
• Assisting in addressing queries raised both during site monitoring visits as well system generated queries, actively engage with Clinical Research Associate (CRA) and participate during exit meetings
• Supporting the Study Coordinators in the management and coordination of studies, preparation of monitor visits, audits and responding/resolving queries in general
• Supporting the Sample Processing Room staff with various functions such as processing of samples and preparation for sampling
• Supporting the Site manager to manage all site staff
• Proactively assists in identifying and manages risk at site
• Communicating effectively with internal and external stakeholders
• Assisting in managing the site to function optimally, supporting company strategic objectives
• Assisting the Site Manager in operationally delegated managerial functions
• Assisting the Site Manager in the complying to and maintenance of the Quality Management System at site level
• Proactively assist with site training and meetings
• Performing miscellaneous job-related duties as assigned

Ideal Requirements

• Nursing degree / diploma (Registered nurse), Biomedical Sciences or relevant qualification in Medicine
• Valid Nursing Council certificate (SANC) or any other professional certification related to qualification
• Previous experience in clinical trials, preferably in a coordinator or similar role
• Supervisory/management experience would be an advantage
• Valid SA and ICH GCP certificate with 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 help out at other TASK sites and to accommodate occasional nightshift and regular weekend schedules (TASK BCH primary site)
• Valid Driver's License

Key Personal Inherent Characteristics

• Position may require occasional travel between different sites.
• Flexibility in working hours may be necessary to accommodate study related and participant requirements.
• Position involves interaction with different groups – healthy volunteers, and/or potentially infectious persons and requires wearing of personal protective gear as provided and where required.

Details:

Area: Brooklyn, Cape Town

Contract Type: 12 Months Fixed Term

Applications Close: 01 December 2025 (16:00)

Please indicate in your application that you are applying for the above-mentioned position.

If you have not received a response within one month, your application was most likely 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.

Job Types: Full-time, Temporary

Contract length: 12 months

Application Question(s):

• What are your gross monthly salary expectations (before deductions)?
• What is your notice period?

Work Location: In person

Application Deadline: 2025/12/01