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In-house Clinical Research Associate
2 weeks ago
In-House Clinical Research Associate (Australia-wide)
**Location**: Sydney NSW, Australia
**Requisition Number**
**345**
**Remote**
Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research - approaching each opportunity with foresight, character, resilience and innovation. Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions.
**_ This is a Full-time role, but Part-time will be considered_**
Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research - approaching each opportunity with foresight, character, resilience and innovation.
**Responsibilities**
- Serves as the primary CRA back-up
- Provides general support to the CTL and CRAs to manage investigational sites and ensure protocol and regulatory compliance
- Contributes to the development of protocol-specific manuals, plans, and documents, as needed
- Assists with the development of training content (monitoring visit training materials, monitoring visit reports, etc.)
- Supports site identification and qualification through feasibility tasks
- Assists with Investigator Meeting planning and attendance
- Assists with resolution of investigational site data queries
- Assists and supports CRAs with Action Item resolution
- Supports CRAs with Investigation Product reconciliation
- Tracks patient enrolment and assists with recruitment efforts by maintaining regular site contacts
- Assists CRAs with document collection and TMF (Trial Master File) uploads
- Co-monitors and/or conducts remote SDV on assigned studies as needed
- Assists the CTL with Action Item and Protocol Deviation review and follow-up, and quality management activities
- Develops or contributes to the development of newsletters
- Maintains FAQs for assigned studies
- Documents site and sponsor contacts and study interactions in a timely and professional manner
- Performs other duties as assigned per study and/or Advanced Clinical needs
**Qualifications**
Education
**Experience**
- 2+ years of clinical research experience in a clinical research site, CRO, or healthcare or industry setting. Prefer scientific discipline and multiple therapeutic experiences.
- Start-up and contracts experience will be an advantage
**Role Competencies**
- Demonstrates basic skills and knowledge relevant to the function. Perform a range of routine assignments under general supervision.
- Communicates openly with customers. Demonstrates active listening.
- Has a good understanding of the services Clinical Monitoring provides. Responds to customer needs in a timely, professional, and courteous manner.
- Understands and adheres to the organization's financial policies, procedures, and standard processes.
- Expresses ideas and suggestions in a clear manner and builds on already successful initiatives to gain support for ideas.
- Assesses work with a critical eye. Participates in practical planning of work processes or problem solving.
- Tasks are typically assigned by a supervisor and/or follow standard work procedures. Performs routine or scheduled maintenance.
- Recognizes, tracks, and reports problems. Resolves problems that are narrow in scope related to simple, routine occurrences. Resolves problems with guidance and direction.
- Demonstrates awareness of key Clinical Monitoring processes. Complies with relevant processes and operating procedures.
- Establishes and nurtures positive relationships with co-workers and customers. Actively listens to others and is open to their ideas.
- Exhibits the REAL values and represents the culture and values of the organization
At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. A diverse staff allows us to effectively draw on different perspectives and enhance our efficiency and effectiveness. Diversity thereby strengthens the legitimacy and relevance of Advanced Group in delivering services to our clients. We seek talented, creative individuals from a variety of backgrounds and cultures to work with us. It is our priority that our workplace be inclusive, welcoming of diverse ideas and appreciative of valuable experience.
Equal Employment Opportunity
It is Advanced Group’s practice not to discriminate against any Employee or applicant because of sex, race, colour, age, national origin, religion, gender, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, physical or mental disab
