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About the Role

As an Assistant Clinical Research Associate (ACRA), you will provide support with site preparedness, logistical support to the monitoring process, and assist with assigned tasks for site management and remote monitoring in accordance with SOPs and regulatory guidelines. You may be assigned limited site contact activities during study start-up, site management, recruitment, and close-out phases.

Responsibilities

• Completes study and site management activities as defined in task matrix, and as applicable and directed for study assigned.
• Completes and documents study-specific training.
• Orients and trains on any study-specific systems.
• Provides in-house support during pre-study assessments and with pre-study assessment waivers, as agreed for project.
• Supports to customize Site ICF with site contact details, as needed.
• Performs remote review of EMR/EHR checklist and supports collection, as applicable assessments.
• Verifies document collection and RCR submission status; updates site EDL and verifies site information.
• Reviews patient facing materials and review translations, as directed.
• Supports site staff with the vendor related qualification process, where applicable.
• Provides support by ensuring system access is requested/granted and revoked for relevant site staff during pre-activation and subsequent course of the study.
• Provides support to follow-up on site training, as applicable.
• Coordinates and supports logistics for IM attendance, as directed.
• Supports maintenance of vendor trackers, as directed.
• Coordinates study/site supply management during pre-activation and subsequent course of the study.
• Supports Essential Document collection, review and updating in systems, as applicable.
• Follows up and supports on missing study vendor data like ECGs, lab samples, and e-diaries, as directed.
• Supports ongoing remote review of centralized monitoring tools, as directed.
• Supports Site payments processes by coordinating with various functional departments within organization and site.
• Supports system updates and reconciliations, as directed and follows-up on site invoices throughout the study period.
• Performs reconciliation tasks on 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 missing/incomplete/expired documents and open document findings, as directed.
• May perform other assigned site management tasks, as directed by CRA and as per Task Matrix.
• May perform a specific role profile for FSP opportunities according to Client requests.
• Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.

Requirements

• Bachelor's degree in a life science discipline or related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years).
• In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
• Basic medical/therapeutic area knowledge and understanding of medical terminology
• Ability to attain and maintain a working knowledge of ICH GCP, applicable regulations and company procedural documents
• Effective oral and written communication skills
• Excellent interpersonal and customer service skills
• Good organizational and time management skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively
• Proven flexibility and adaptability
• Ability to work in a team or independently, as required
• Well-developed critical thinking skills, including but not limited to critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
• Proficient computer skills with good knowledge of MS Office ability to learn and use appropriate software.
• Leverage modern technology when applicable
• Ability to extract pertinent information from all study documents, electronic study data systems, CTMS and dashboards
• Excellent English language and grammar skills

Skills

• MS Office
• ICH GCP
• Medical Terminology
• Critical Thinking
• Time Management
• Customer Service
• Interpersonal Skills
• Organizational Skills
• Attention to Detail
• Flexibility
• Adaptability
• Teamwork
• Independent Work
• Problem Solving
• Communication Skills

Location

• Home-based
• Melbourne
• Sydney
• Brisbane

Work Type

• Office
• Home Office
• Standard (Mon-Fri)

Experience Level

• 0-2 years

Education Level

• Bachelor's degree in a life science discipline or related field
• Registered Nursing certification

Benefits

• Comprehensive benefits
• Wellness programs
• Employee Assistance Program
• Flexible arrangements
• Generous leave policies
• Option to purchase additional leave
• Paid birthday leave
• Company paid parental leave
• Paid volunteer time
• Access to online courses via Thermo Fisher Scientific University Plus
• LinkedIn learning
• Workshops
• Mentorship programs

About the Company

• Thermo Fisher Scientific is a global company enabling customers to make the world healthier, cleaner and safer.
• Our work spans laboratory, digital and decentralized clinical trial services.
• We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
• As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement.
• Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion.
• Our Mission is to enable our customers to make the world healthier, cleaner and safer.
• We deliver an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

Equal Opportunity

• WGEA Employer of Choice for Gender Equality
• Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
• We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
• Thermo Fisher Scientific is an Equal Opportunity Employer.
• All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.