Sr Clinical Research Associate II - Sydney

Fortrea

Sydney

6 days ago

Sydney

6 days ago

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Sr Clinical Research Associate II - Sydney

The Senior Clinical Research Associate II is responsible for site monitoring and management for clinical studies according to Fortrea and Sponsor SOPs and regulatory guidelines. The role requires advanced clinical monitoring experience with at least 2 years in Oncology, Ophthalmology, or Gene Therapy. The position is based in Sydney, Australia.

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On-site

Full-time

Senior

Salary

Not specified

Work Location

Sydney, New South Wales, Australia, AU

Work Model

On-site

Experience Required

2 years

Employment Type

Full-time

Experience Level

Not Applicable

Core Qualifications

Soft Skills

site managementmonitoringregulatory knowledgecommunicationproblem solvingplanningorganizationteamworkmentoring

Key Responsibilities

•Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors.
•Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study.
•Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
•Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review.
•Prepare accurate and timely trip reports.
•Serve as lead monitor for a protocol or project and may assist in establishing monitoring plans and trip report review.
•Organize and make presentations at Investigator Meetings.
•Assist with training, mentoring and development of new employees, e.g., co-monitoring.
•Coordinate designated clinical projects as a Local Project Coordinator, and may act as a local client contact.
•Negotiate study budgets with potential investigators and assist the Fortrea legal department with statements of agreements.

Clinical ResearchCRAOncologyOphthalmologyGene TherapySite MonitoringAustraliaFull-time

Key Responsibilities

•Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors.

•Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study.

•Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.

•Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review.

•Prepare accurate and timely trip reports.

•Serve as lead monitor for a protocol or project and may assist in establishing monitoring plans and trip report review.

•Organize and make presentations at Investigator Meetings.

•Assist with training, mentoring and development of new employees, e.g., co-monitoring.

•Coordinate designated clinical projects as a Local Project Coordinator, and may act as a local client contact.

•Negotiate study budgets with potential investigators and assist the Fortrea legal department with statements of agreements.