Senior Clinical Trial Coordinator

UniSC•New Braunfels, TX

2d•A$105,843 - A$115,703•Hybrid

About The Position

This role involves leading and guiding assigned clinical trial teams to ensure all trials are conducted to the highest quality standards, including ICH/GCP, UniSC CT SOPs, and applicable regulations. The position requires independent management of complex trial coordination activities, applying expert knowledge of clinical research procedures, sound judgment, and innovative problem-solving skills to achieve outcomes efficiently and effectively. The role also requires flexibility to travel to different clinical trial sites, work outside standard business hours for confinement studies and other time-sensitive activities, and potentially participate in a 24/7 on-call or confinement roster.

Requirements

Completion of a degree in Health Science/Nursing/Bio Medical and extensive relevant experience as a Clinical Trial Coordinator/Research Nurse or similar, or an equivalent combination of experience and/or education/training.
Registered Nurses must have current registration with AHPRA and meet the Nursing and Midwifery Board of Australia professional standards.
Demonstrated experience, expertise, and broad knowledge in ethics/regulatory affairs frameworks.
Detailed knowledge of clinical research practices, including an understanding of the contractual and ethical obligations of clinical trials, and ICH Good Clinical Practice and applicable regulations.
High level computing skills (including databases, clinical trial electronic data entry, word processing and spreadsheets).
Sound understanding of privacy principals governing health information.
Demonstrated ability to work independently as well as collaboratively with peers, colleagues, and other team members.
Strong expertise in ethics and regulatory frameworks.
Solid knowledge of clinical research practices, ICH Good Clinical Practice, and relevant regulations.
Proficiency with databases, electronic data capture, and standard office software.
Understanding of privacy principles for health information.

Responsibilities

Apply clinical trial expertise to manage the implementation and conduct of clinical research, and designated clinical trial teams, in accordance with the appropriate quality standards including International Conference on Harmonization (ICH)/Good Clinical Practice (GCP), UniSC CT’s standard operation procedures (SOPs), and applicable regulations, rules and guidance.
Collaborate with the CT’s team and sponsors to monitor and ensure the successful conduct and timely completion of clinical trials.