Senior Clinical Research Associate, SCRA

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

📋 Description

• Oversee and manage clinical trials.

• Monitor clinical trial sites to ensure adherence to study protocols, ICH-GCP guidelines, and regulatory standards.

• Conduct pre-study site selection, initiation, routine monitoring, co-monitoring, and close-out visits.

• Validate the accuracy, completeness, and integrity of case report forms and source documents.

• Identify and address site-related issues while providing necessary training to site personnel.

• Assess site practices and escalate quality concerns as needed.

• Ensure appropriate documentation, timely data collection, and the achievement of study milestones.

• Maintain communication with investigators, site staff, and internal project teams.

• Assist with regulatory and ethics submissions as well as site contract negotiations.

• Prepare monitoring visit reports and follow-up correspondence.

• Support audit preparedness and engage in sponsor or regulatory inspections.

• Track recruitment and enrollment, CRF completion, and resolution of data queries.

• Collaborate with the CRA Group/CRM and study team members on recruitment strategies, contingency plans, and study execution.

• Participate in onboarding, disease indication, project-specific, and general CRA training.

• Conduct Assessment Visits as necessary.

• Aid in managing clinical trials and undertake additional assigned responsibilities.

⛳️ Requirements

• Bachelor’s degree or higher in life sciences, pharmacy, nursing, or medicine.

• More than 3.5 years of monitoring experience in clinical trials (CRA or Sponsor).

• Strong knowledge of ICH-GCP, clinical trial processes, and regulatory guidelines.

• Proficient in Microsoft Word, Excel, PowerPoint, and Outlook.

• Fluent in both written and spoken English.

• Must possess a valid driver’s license and a reliable vehicle suitable for business travel.

• Ability to manage multiple tasks, prioritize effectively, and meet time-sensitive deadlines throughout the study lifecycle.

🏝️ Benefits

• Competitive compensation package aligned with market standards.

• Annual bonus scheme based on performance.

• Company shares with a generous welcome grant!

• Opportunities for in-house and external learning and development.

• Excellent benefits program.