Clinical Research Associate II – FSP

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

📋 Description

• Ensure the appropriate execution of clinical trials in accordance with the Study Monitoring Plan, relevant laws, GCP, and client standards.

• Oversee clinical trial operations at designated investigator sites, from site activation to database lock.

• Act as the main point of contact for the assigned investigator sites.

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

• Conduct investigator site development, coaching, and training alongside the SCP.

• Provide training on protocols and address any protocol-related inquiries.

• Participate in investigator meetings and aid in enrollment and site recruitment efforts.

• Perform onsite and remote/electronic monitoring for site initiation, routine checks, and site closure.

• Monitor adverse and serious adverse events, collaborating with the Drug Safety Unit.

• Submit necessary reports, documentation, updates, and tracking, including TMF documentation, site reports, protocol deviations, recruitment metrics, clinical supplies, and overall study progress.

• Identify and address issues at investigator sites, developing corrective and preventive measures.

• Resolve data queries and conduct close-out activities for investigator sites.

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

• Support database release as required.

• Assume unblinded monitor responsibilities when appropriate.

• Maintain expertise in product, protocol, and therapy-area knowledge.

• Provide support regarding patient safety, eligibility, and clinical guidance to investigators.

• Drive remediation of Quality Events and assist with audit CAPA activities when applicable.

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

• Collaborate with the SCP, Country Study Operations Manager, and other 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 necessary training, timesheets, expense reports, and CV updates.

• Maintain compliance with Parexel processes, ICH-GCP, and applicable regulations.

⛳️ Requirements

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

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

• Ideally, 2 years of experience in Oncology.

• Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine, or Infectious Diseases.

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

• Experience with global clinical trials.

• Proficiency in English and the native language(s) of the country of employment.

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

• Proven knowledge of clinical research and development processes.

• Familiarity with global and local regulatory requirements.

• Understanding of monitoring, data acquisition and cleaning, reporting, and other operational aspects of clinical research.

• Knowledge of diseases and technical areas related to clinical studies.

• Ability to support sponsor regulatory interactions and inspections.

• Knowledge of protocol design and feasibility assessment processes.

• Understanding of regional/country culture, medical practices, and their impact on clinical trial delivery.

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

• Skills to evaluate, interpret, and present complex issues and data for risk management and mitigation.

• Strong verbal and written communication skills.

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

🏝️ Benefits

• Significant travel (60-80%) within the area is required; this may include some international and weekend travel.