Clinical Research Associate II – FSP

This is a fully remote position, open to applicants in Australia.

📋 Description

• Ensure that clinical trials are executed in accordance with the Study Monitoring Plan, relevant laws, GCP, and client standards.

• Oversee clinical trial operations at designated investigator sites from initiation through to database lock.

• Act as the primary liaison for assigned investigator sites and escalate any issues to the SCP as necessary.

• Facilitate seamless communication among study team members, vendors, and investigator sites.

• Conduct site development, coaching, and training; deliver protocol training and address inquiries from sites.

• Participate in investigator meetings and assist with enrollment, site activation, recruitment, and related initiatives.

• Carry out onsite and remote/electronic monitoring for site initiation, routine monitoring, and site closure.

• Monitor adverse events and serious adverse events; collaborate with Drug Safety and investigators to address reports.

• Submit necessary TMF documentation, site reports, follow-up letters, protocol deviations, recruitment data, clinical supply details, study progress, and metrics updates.

• Identify and resolve issues at sites; develop corrective and preventive action plans.

• Address data queries and execute investigator site close-out activities.

• Oversee the receipt, handling, accounting, storage, and disposal of investigational products.

• Assist with database release and take on unblinded monitor responsibilities where applicable.

• Maintain knowledge of products, protocols, and therapy areas to support patient safety and eligibility.

• Drive remediation for Quality Events and audit CAPA activities as needed.

• Report to the Director of Clinical Site Operations or Director of Site Management and Monitoring.

• Collaborate with SCP, Country Study Operations Manager, and other study team members.

• Mentor and train Clinical Research Associates and Senior CRA I as assigned.

• Serve as a subject matter expert on related initiatives and planning.

• Complete all required training, timesheets, expense reports, and CV updates; adhere to Parexel processes, ICH-GCP, and applicable requirements.

⛳️ Requirements

• A minimum of 3+ years of CRA experience specifically from Australia/New Zealand.

• At least 3 years of relevant experience in clinical research site monitoring.

• Comprehensive knowledge of clinical trial methodologies, ICH/GCP, FDA, and local regulations.

• Experience in global clinical trials.

• Proficiency in English and the native language(s) of the country where you will be working.

• Willingness to travel significantly (60–80%) within the region; some international and weekend travel may be necessary.

• A valid driver’s license and passport are required.

• Familiarity with clinical research and development processes.

• Understanding of global and local regulatory requirements.

• Knowledge of monitoring, data acquisition and cleaning, reporting, and other operational elements.

• Familiarity with disease and technical areas pertinent to clinical studies, investigational products, and development plans.

• Ability to assist with sponsor regulatory interactions and inspections.

• Knowledge of protocol design and feasibility assessment processes.

• Awareness of regional/country culture and medical practices that impact clinical trial execution.

• Capacity to work effectively in a matrix team environment, influencing and leading through collaboration.

• Ability to assess, interpret, and present complex issues and data for risk management and mitigation.

• Strong verbal and written communication skills.

• A Bachelor’s degree in life sciences or a relevant professional degree in life sciences such as nursing, pharmacy, or a medical background, or equivalent.

🏝️ Benefits

• Competitive salary and performance bonuses.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and growth.

• Flexible work arrangements and work-life balance initiatives.