At a Glance
- Tasks: Be the go-to person for clinical study sites, ensuring all documents are collected and submitted on time.
- Company: Join a leading organisation in clinical trials with a focus on innovation and teamwork.
- Benefits: Enjoy competitive pay, flexible hours, and opportunities for professional growth.
- Other info: Dynamic role with plenty of chances to learn and advance your career.
- Why this job: Make a real difference in healthcare by supporting vital clinical research projects.
- Qualifications: A degree in life sciences or related field, plus some experience in clinical trials.
The predicted salary is between 47250 - 57750 $ per year.
Primary contact with clinical study sites during study maintenance and site startup activities, with responsibility for collection of required investigator and regulatory essential documents to ensure HREC & RGO submissions are made within agreed timelines.
Key responsibilities
- Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner.
- Collect and track all necessary documents and perform quality review, formatting, and compilation of final documents for effective and compliant site activation and maintenance.
- Assist senior staff to compile, prepare, submit, and obtain approval of submission documents to Ethics/Regulatory Authority in accordance with local requirements.
- Ensure all assigned maintenance and start-up activities are on track and in accordance with client expectations, ICH/GCP, SOPs, budget, quality and applicable laws and guidelines.
- Update study documents when there are changes in study personnel or study amendments.
- Ensure high quality documents are filed and systems are updated on an ongoing and timely basis.
- Update status reports, applicable logs, and tracking systems as applicable for projects.
- Adapt Informed Consent Forms and other patient facing material to country specific requirements with guidance from line manager and experienced colleagues.
- Liaise with internal and external vendors in the generation of Regulatory Authority submissions.
- Escalate study issues appropriately and in a timely fashion.
About you
- University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology).
- Minimum 1 + years of clinical trial experience, and ability to successfully perform the key responsibilities.
- Working knowledge of ICH, HREC, RGO, and other applicable regulations/guidelines.
- Demonstrated basic understanding of the clinical trial process.
Study Start-up Associate in Sydney employer: Fortrea
Fortrea is an exceptional employer for the Senior Clinical Research Associate II role, offering a dynamic work culture that prioritises employee growth and development. With a commitment to innovation in clinical research, employees benefit from comprehensive training programs, opportunities for advancement, and a supportive environment that values collaboration and integrity. Located in a vibrant area, Fortrea provides a unique advantage with access to cutting-edge resources and a network of professionals dedicated to making a meaningful impact in healthcare.
