This is a full-time & permanent opportunity for a Clinical Research Coordinator to join our growing 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.
If this opportunity interests you, please apply with your current CV
Job Types: Full-time, Permanent
Pay: $85,000.00 – $90,000.00 per year
Work Authorisation:
Work Location: In person
