What is in for you:
- Home- Based Role SCRA - Lead CRA
- Local Travel
- Attractive remuneration package
- Shared Bonus Scheme
- Offer excellent career goals and personal growth along with personal benefits
- The client focus on clinical trial early phase and phase 1, local regulatory and deep therapeutic expertise
The Role Responsibilities:
- Full ownership of investigator sites for assigned studies with responsibility for the successful management of the site right through to close-out.
- Prepare, organise, conduct and follow-up routine monitoring and close out visits as per relevant study plan
- Ensure ethics submissions are made by investigator sites in a timely manner.
- Adherence to ICH-GCP and any other regulatory guidelines and requirements including adverse events and serious adverse event reporting
- Compliance with mandatory SOPs as agreed for the study
- Being a resource for other CRAs, mentoring junior-level staff and sharing knowledge and best practices.
- Participating in training offered to increase therapeutic knowledge and keeping current with regulations and TGA guidance.
- Must have at least +5 years of Experience in the similar capacity.
- Including conducting independent monitoring visits, from either a pharmaceutical company or a CRO environment.