In-House Clinical Research Associate I

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

📋 Description

• Assist with the initiation of site activities, including coordinating feasibility questionnaires, gathering confidentiality agreements, and managing essential documents.

• Oversee the distribution and monitoring of study materials to investigative sites while ensuring accurate documentation.

• Evaluate site documentation for quality assurance and completeness.

• Aid in the maintenance and reconciliation of the Trial Master File (TMF).

• Perform remote monitoring tasks and assist during pre-study, initiation, interim, and closeout visits under the supervision of Clinical Trial Managers and field CRAs.

• Maintain consistent communication with investigative sites and provide operational assistance.

• Help address questions and issues related to the study.

• Assess electronic case report forms and study data for thoroughness, consistency, and adherence to compliance standards.

• Provide support to sites on data management inquiries, vendor-related requests, study recruitment efforts, and subject eligibility tracking.

• Create study reports, keep study trackers updated, and furnish operational updates for project oversight and informed decision-making.

• Assist with changes in site personnel, training documentation, regulatory document collection, and vendor access management.

• Collaborate with Clinical Trial Managers, field CRAs, sites, and cross-functional project teams to facilitate clinical research studies and ensure compliance with GCP, relevant regulations, and study requirements.

⛳️ Requirements

• A bachelor's degree in medical, biological, physical, health, pharmacy, or a related science field is preferred; alternatively, equivalent education, training, and pertinent clinical research experience are acceptable.

• Experience in clinical research roles such as Study Coordinator, Clinical Trial Assistant, or other relevant research positions.

• Familiarity with clinical research principles, processes, and Good Clinical Practice (GCP) standards.

• Knowledge of FDA and/or EU regulations, ICH Guidelines, local regulatory requirements, and standard operating procedures.

• Experience with electronic data capture (EDC), eCRF, IVRS, and other clinical research systems.

• Strong skills in planning, organization, and time management, with the capability to handle multiple priorities efficiently.

• Excellent communication and interpersonal skills, with the ability to collaborate effectively across sites and cross-functional teams.

• Proficiency in both spoken and written English.

• Candidates must reside in Australia.

🏝️ Benefits

• Diverse and inclusive workplace.

• Supportive and collaborative teams.

• Accessible leadership.

• Equal employment opportunities.

• Exceptional employee experiences.

• Remote work options.