Clinical Trial Site Study Coordinator - Cape Town, South Africa - TASK

TASK

Verified Company

Cape Town, South Africa

1 week ago

Posted by:

Thabo Mthembu

beBee Recruiter

Description

Clinical Trial Site Study Coordinator

Overall Purpose of the Position:

A clinical 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, data collection, participant care, participant advocacy and recruitment.

This role demands meticulous attention to detail, excellent organisational 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.

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

Protocol Adherence

Ensuring strict adherence to study protocols, regulatory guidelines, and standard operating procedures (SOPs) whilst ensuring participant safety throughout the conduct of the clinical trial.

Participant Recruitment and Screening

Collaborating with the recruitment team to identify and screen potential participants according to study 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.
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 and performing clinical trial activities, including scheduling study preparation, setup and readiness, participant visits, performing study procedures according to scope, relevant compliancy checks, quality and timely data collection and entry.
Monitoring participant safety and reporting adverse events according to protocol and regulatory requirements.
Educating participants on study related requirements and compliance.

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.
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.
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

Tertiary Diploma or bachelor's degree in a related health science field, (chemistry, biology, or nursing, etc.).
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

Computer literacy

Ability to use Word, PowerPoint and Excel at intermediate level.

Key Personal Inherent Characteristics

Excellent organisational skills with the ability to prioritise 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
Selfdriven

Area:
Bellville, Brooklyn, Delft

Contract Type: 12 Months Fixed-Term

Applications Close:26 March 2024

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.

Job Types:
Full-time, Temporary

Contract length: 12 months

Application Deadline: 2024/03/26