Assistant CRA – ACRA

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

📋 Description

• Executes study and site management tasks as outlined in the task matrix and as directed for the assigned study.

• Completes and records study-specific training activities.

• Provides orientation and training on any study-specific systems.

• Offers in-house assistance during pre-study assessments and handles pre-study assessment waivers, as per project agreements.

• Aids in customizing the Site ICF with site contact information, as necessary.

• Conducts remote reviews of the EMR/EHR checklist and supports data collection, as applicable assessments require.

• Confirms the status of document collection and RCR submissions; updates site EDL and verifies site details.

• Reviews patient-facing materials and translations, as instructed.

• Assists site staff with the vendor qualification process, where applicable.

• Ensures system access is requested, granted, and revoked for relevant site personnel during pre-activation and throughout the study.

• Aids in following up on site staff training, as necessary.

• Coordinates and supports logistics for IM attendance as directed.

• Helps maintain vendor trackers as instructed.

• Manages study/site supply logistics during pre-activation and throughout the study.

• Aids in the collection, review, and updating of Essential Documents in systems, as applicable.

• Follows up on missing study vendor data such as ECGs, lab samples, and e-diaries as directed.

• Supports the ongoing remote review of centralized monitoring tools as instructed.

• Assists with site payment processes by coordinating with various functional departments within the organization and site.

• Aids in system updates and reconciliations as directed, and follows up on site invoices throughout the study period.

• Conducts reconciliation tasks for assigned trials, including but not limited to CRF and query status, deviations, SAEs, and safety reports, as applicable.

• Verifies document collection status in company systems and drives action for any missing, incomplete, or expired documents and open document findings, as directed.

• May undertake other assigned site management tasks as directed by CRA and as per the Task Matrix.

• May fulfill a specific role profile for FSP opportunities based on Client requests.

• Completes and maintains administrative tasks such as expense reports and timesheets in a timely manner.

⛳️ Requirements

• Bachelor’s degree in a life science discipline or a related field, or a Registered Nursing certification, or equivalent relevant formal academic/vocational qualification.

• Previous experience providing the knowledge, skills, and abilities necessary to perform the job (equivalent to 0 to 2 years).

• Basic understanding of medical/therapeutic areas and medical terminology.

• Ability to acquire and maintain a working knowledge of ICH GCP, relevant regulations, and company procedural documents.

• Strong oral and written communication skills.

• Excellent interpersonal and customer service abilities.

• Good organizational and time management capabilities with a strong attention to detail, proven ability to manage multiple tasks efficiently and effectively.

• Demonstrated flexibility and adaptability.

• Ability to work collaboratively in a team or independently, as needed.

• Well-developed critical thinking skills, including critical mindset, thorough investigation for proper root cause analysis, and problem-solving capabilities.

• Proficient in computer skills with a solid understanding of MS Office and ability to learn and utilize relevant software.

🏝️ Benefits

• Join a company that emphasizes your health and wellbeing with extensive benefits, wellness programs, and an Employee Assistance Program that offers confidential support for both personal and work-related issues.

• Achieve work-life balance with flexible arrangements.

• Enjoy generous leave policies, including options for purchasing additional leave, paid birthday leave, and company-paid parental leave.

• Make a difference with paid volunteer time to support non-profit organizations that are important to you.

• Enhance your career with access to online courses through Thermo Fisher Scientific University Plus and LinkedIn Learning, along with workshops and mentorship programs for ongoing learning and skill development.