Endogenex is a clinical-stage medical technology company developing a novel, endoscopic procedure for people with type 2 diabetes. Its system uses controlled pulsed electric fields applied to the duodenum to reset metabolic signalling, designed to help the body improve glycemic control, aiming to go beyond current pharmacologic treatments and slow disease progression.
Role Description
The Senior Clinical Research Associate (Sr. CRA) is a contract based, full-time role based in either Sydney NSW, or Melbourne VIC, Australia. The role will support the execution of clinical studies by performing monitoring activities, coordinating with investigative sites, and ensuring high-quality data collection in compliance with GCP, TGA regulations, and local regulatory requirements. The successful candidate will participate in study start-up, monitoring, and close-out activities and collaborate with internal teams, CROs, vendors, investigators, and site coordinators. Strong communication, organisational skills, and attention to detail are essential. Domestic travel is required.
Qualifications
* Minimum of a bachelor\'s degree in life sciences or a related field.
* Minimum of 5 years' experience in clinical research, 3+ years in monitoring/auditing clinical studies.
* Thorough knowledge of TGA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials.
* Exceptional problem-solving, communication, and organisational skills.
* Ability to work collaboratively in a hybrid work environment with occasional travel.
* Excellent verbal and written communication, problem-solving, and interpersonal skills, high level of attention to detail, proficient in MS Office, Word, Excel and data analytics platforms.
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