At a Glance
- Tasks: Conduct site visits, ensure compliance, and support clinical trials across Australia.
- Company: Global clinical research organisation focused on innovative therapies.
- Benefits: Flexible remote part-time role with competitive pay and professional growth.
- Other info: Opportunity to travel and collaborate with global teams.
- Why this job: Make a real difference in patient outcomes while working with cutting-edge research.
- Qualifications: 3+ years in clinical research and strong knowledge of trial processes required.
The predicted salary is between 56700 - 69300 $ per year.
Join a global clinical research organization dedicated to advancing innovative therapies and improving patient outcomes.
We are seeking an experienced Contract Clinical Research Associate (CRA) to support the successful delivery of clinical trials across Australia.
This is a remote, part-time opportunity (0.4 FTE) offering flexibility while working closely with investigative sites and cross-functional study teams.
Key Responsibilities
- Conduct site qualification, initiation, monitoring, and close-out visits.
- Assess and identify suitable investigative sites and support site selection activities.
- Train site personnel on study protocols, regulatory requirements, and study procedures.
- Ensure sites remain compliant with GCP, local regulations, sponsor requirements, and study protocols.
- Perform source data verification and review clinical documentation for accuracy, completeness, and consistency.
- Monitor investigational product accountability, storage, dispensing, and reconciliation.
- Support submissions to Ethics Committees and Regulatory Authorities, as required.
- Manage site communications, action items, and issue resolution throughout the study lifecycle.
- Review and maintain essential study documentation within the Trial Master File (TMF).
- Facilitate data query resolution and ensure timely reporting of study activities.
- Build and maintain strong relationships with investigators, study coordinators, and internal stakeholders.
- Participate in study team meetings and contribute to project success.
Skills & Qualifications
- Strong knowledge of clinical trial processes, ICH-GCP guidelines, and applicable regulatory requirements.
- Excellent written and verbal communication skills.
- Strong organisational, time management, and problem-solving abilities.
- Ability to effectively manage multiple priorities and deadlines.
- Proficient in clinical trial systems and Microsoft Office applications.
- Strong interpersonal skills and the ability to work collaboratively within global teams.
- Commitment to quality, accuracy, and patient safety.
- Ability to travel up to 75% as required.
- Valid driver's licence.
Experience & Education
- Bachelor's degree in Life Sciences, Nursing, or a related field, or an equivalent combination of education and relevant experience.
- Successful completion of a recognised CRA training programme.
- Minimum of 3 years' clinical research experience, including experience as a Clinical Trial Associate, Study Coordinator, Clinical Research Associate, or similar role.
- Oncology therapeutic experience is preferred.
- Experience independently conducting site monitoring visits across all phases of a clinical trial.
- Strong understanding of site management, protocol compliance, patient safety, and data quality requirements.
Clinical Research Associate (Contractor) in Gold Coast employer: Linical
As a Clinical Trial Manager with us, you'll be part of a dynamic team dedicated to advancing healthcare through innovative clinical research. We pride ourselves on fostering a collaborative work culture that values operational excellence and professional growth, offering comprehensive training and development opportunities tailored to your career aspirations. Located in a vibrant area, our company provides unique advantages such as flexible working arrangements and a commitment to employee well-being, making it an exceptional place to build a meaningful career.
