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About the Role
As an Inhouse Clinical Research Associate, you'll support the successful delivery of clinical research studies, ensuring compliance with GCP, regulations, and study requirements. You will partner in site management, documentation, monitoring support, and communication to drive high-quality study execution and patient-focused outcomes.
Responsibilities
- Support site start-up activities, including feasibility questionnaire coordination, confidentiality agreement collection, and essential document management.
- Coordinate the distribution and tracking of study materials to investigative sites and ensure accurate documentation is maintained.
- Review site documentation for quality and completeness and support Trial Master File (TMF) maintenance and reconciliation activities.
- Conduct remote monitoring activities and support pre-study, initiation, interim, and closeout visits.
- Maintain regular communication with investigative sites, providing operational support and helping resolve study-related questions and issues.
- Review electronic case report forms and study data for completeness, consistency, and compliance with study requirements.
- Assist sites with data management queries, vendor-related requests, study recruitment activities, and subject eligibility tracking.
- Generate study reports, maintain study trackers, and provide operational updates.
- Support site personnel changes, training documentation, regulatory document collection, and vendor access management.
Requirements
- A four-year degree with a concentration in medical, biological, physical, health, pharmacy, or another related science field preferred; alternatively, equivalent education, training, and relevant clinical research experience.
- Clinical research experience in roles such as Study Coordinator, Clinical Trial Assistant, or other relevant research positions.
- Understanding of clinical research principles, processes, and Good Clinical Practice (GCP) requirements.
- Knowledge of FDA and/or EU regulations, ICH Guidelines, local regulatory requirements, and standard operating procedures.
- Familiarity with electronic data capture (EDC), eCRF, IVRS, and other clinical research systems.
- Strong planning, organization, and time management skills with the ability to manage multiple priorities effectively.
- Excellent communication and interpersonal skills with the ability to collaborate across sites and cross-functional teams.
- Proficiency in spoken and written English.
Skills
- GCP
- FDA regulations
- EU regulations
- ICH Guidelines
- EDC
- eCRF
- IVRS
- Planning
- Organization
- Time management
- Communication
- Interpersonal skills
Location
- Australia
- Remote
Work Type
- Remote
Education Level
- Four-year degree in a related science field or equivalent experience
About the Company
- Worldwide Clinical Trials is a global, midsize CRO that pushes boundaries and innovates to find cures for diseases.
- The company has over 3,500+ experts worldwide.
- Their mission is to work with passion and purpose every day to improve lives.
- They believe everyone plays an important role in making a world of difference for patients and their caregivers.
- They prioritize cultivating a diverse and inclusive environment that promotes collaboration and creativity.
- They are committed to enabling professionals from all backgrounds and experiences to succeed.
Equal Opportunity
- Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity.
- We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful.
- We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity.
- We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.