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This is a full-time & permanent opportunity for a Clinical Research Coordinator to join our team at our clinical research site in Wollongong.
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:
1. Establish and organise study files, including regulatory binders, study specific source documentation and other materials as required.
2. Work closely with the patient recruitment team to ensure recruitment targets and timelines are met.
3. Liaise directly with patients to ensure they are aware of all trial-related requirements and attend all trial-related appointments and assessments.
4. 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), and National Health and Medical Research Council (NHMRC).
5. Be available to discuss any trial-related queries with patients and liaise with investigators to ensure all questions and concerns are addressed.
6. Schedule protocol-specific assessments and procedures, ensuring Investigators are available during study visits to perform required tasks.
7. Review patient EMR for each completed visit to ensure all data has been collected, all procedures properly completed and documented.
8. Ensure that all Adverse Events and Serious Adverse Events are properly reported within expected timelines.
9. Maintain all study-related documentation and ensure data queries are completed in a timely manner.
10. Complete all study close-out activities including archiving of all study records.
11. Ensure all discrepancies and deviations are properly addressed and documented.
12. Prepare for and host initiation, monitoring, and close-out visits.
13. Maintain open and regular communication with key stakeholders, in particular sponsor representatives.
14. Assist with audit and inspection preparations.
15. Perform ad-hoc duties as delegated by your supervisor.
16. Make sure all study-related logs are up to date.
The successful candidate will have the following skills/experience:
1. Minimum 2 years' experience in a similar role.
2. Demonstrated experience in a clinical environment, including conducting and coordinating pharma-sponsored clinical trials.
3. A background in Nursing will be highly regarded.
4. Excellent interpersonal, verbal, and written communication skills.
5. Proficiency in using CTMS and EDC systems.
6. Strong administration skills are essential to the success of this position.
7. Ability to work independently with a high level of initiative but also work well within a team.
8. Demonstrated understanding of clinical trials methodology and knowledge of Good Clinical Practice (ICH-GCP) requirements.
9. Ability to work within a team environment of Nurses, Phlebotomists, Receptionists, Doctors, and the Site Director.
10. 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.
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Your application will include the following questions:
* Which of the following statements best describes your right to work in Australia?
* How many years' experience do you have as a Clinical Research Coordinator?
* What's your expected annual base salary?
* How much notice are you required to give your current employer?
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