Clinical Research Coordinator

Canopy Clinical Research; Sydney; On-site; AUD 65,000 - 90,000; Full time

Job summary

Walski Clinical Research in Brookvale on Sydney's Northern Beaches is seeking a Clinical Research Coordinator for a full-time, permanent position at our Sydney site.

You will oversee trial responsibilities, ensure regulatory compliance, coordinate with nurses and investigators, manage patient recruitment, and maintain study documentation, including source data and adverse event reporting.

Qualifications

• Minimum 3 years of experience in a similar role.
• Experience coordinating pharma-sponsored trials.
• Proficiency with CTMS and EDC systems.
• Excellent interpersonal, verbal and written communication skills.

Responsibilities

• Establish and organise study files including regulatory binders and source documents.
• Coordinate patient recruitment targets and timelines with the recruitment team.
• Liaise with patients to ensure they attend trial-related appointments and assessments.
• Ensure trials comply with ICH-GCP, TGA, NHMRC guidelines.
• Review EMR, ensure data completeness and proper documentation.
• Report Adverse Events/Serious Adverse Events within timelines.
• Prepare for and support initiation, monitoring and close-out visits.
• Maintain logs and study records; assist with audits/inspections.

Skills

Clinical trials coordination

Communication

Attention to detail

Team player

Independent work

Tools

CTMS

EDC

Job description

This is a full-time & permanent opportunity for a Clinical Research Coordinator to join the team at our clinical research site in Brookvale on the beautiful Northern Beaches of Sydney.

As the Clinical Research Coordinator, you will have a thorough understanding of all trials being conducted at your site, particularly the protocols, investigator brochures, participant information and consent forms, timelines, and safety reporting requirements.

Your other main responsibilities will include:

Establish and organise study files, including regulatory binders, study specific source documentation and other materials as required.

Working closely with patient recruitment team to ensure recruitment targets and timelines are met.

Liaise directly with patients to ensure they are aware of all trial related requirements and ensure they attend all trial related appointments and assessments.

Ensure research studies are conducted in adherence to the requirements of the International Conference on Harmonisation (ICH) guideline for Good Clinical Practice (GCP), Therapeutic Goods Administration (TGA), National Health and Medical Research Council (NHMRC).

Be available to discuss any trial related queries with patients and liaise with investigators to ensure all questions and concerns are addressed.

Schedule protocol specific assessments and procedures ensuring Investigators are available during study visits to perform required tasks.

Review patient EMR for each completed visit to ensure all data has been collected, all procedures properly completed and documented.

Ensure that all Adverse Events and Serious Adverse Events are properly reported withing expected timelines.

Maintain all study related documentation and ensure data queries are completed in a timely manner.

Complete all study close out activities including archiving of all study records.

Ensure all discrepancies and deviations are properly addressed and documented

Prepare for and host initiation, monitoring and close out visits

Maintain open and regular communication with key stakeholders, in particular sponsor representatives.

Assisting with audit and inspection preparations.

Perform ad-hoc duties as delegated by your supervisor.

Make sure all study related logs are up to date.

The successful candidate will have the following skills/experience:

Minimum 3 years’ experience in a similar role

Demonstrated experience in a clinical environment; which includes conducting and coordinating pharma sponsored clinical trials

Excellent interpersonal, verbal and written communication skills

Proficiency in using CTMS and EDC systems

Strong administration skills are essential to the success of this position

Ability to work independently with a high-level of initiative but also work well within a team

Demonstrated understanding of clinical trials methodology and knowledge of Good Clinical Practice (ICH-GCP) requirements

Ability to work within a team environment of Nurses, Phlebotomists, Receptionists, Doctors and the Site Director

High level of attention to detail

About us:

Walski Clinical Research is a dedicated, multi-site, private Clinical Trials network on the East-coast of Australia. We conduct trials on a broad therapeutic range, from Phase 1 through to Phase 4. We excel in generalist studies with a large volunteer recruitment pool and have proven to be equally capable in delivering results for more specialist indications requiring patients.