Clinical Research Associate II / Sr CRA, Australia
Bring your Passion to Premier!
Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality. We have positioned ourselves right in the middle of the action, targeting unmet needs in Rare Disease and Pediatrics, Analgesia, Neuroscience, Oncology, Dermatology, and Medical Devices.
We're looking for a talented and energetic Clinical Research Associate II / Sr CRA based in Australia to join our team!
Working at Premier Research means being an individual - you will be recognized for what you do and you will truly have an impact in an aspiring, empowering and caring culture where people truly work as one team. You can grow and contribute your expertise with colleagues who are genuinely supportive regardless of location or seniority. Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it!
Clinical Research Associates are accountable for conducting monitoring activities of assigned clinical trials in compliance with the protocol, ICH-GCP/ISO14155 and all applicable local laws and regulations, company policies and quality standards. He or she performs the management of study site activities to ensure the collection of accurate clinical data within given timelines. The CRA proactively identifies, resolves/mitigates and escalates risks and/or issues, may be responsible for multiple studies and must work independently with team support.
What you'll be doing:
- Delivers quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan timelines
- Maintains submission of expenses according to travel and expense requirements within company guidelines
- Responsible for the validity, correctness, and completeness of the clinical data reviewed and collected at assigned sites as dictated by ICH GCP/ISO14155, protocol and client requirements
- Monitors (remote, onsite or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with specific country regulations
- Plans day to day activities for monitoring of a clinical study and sets priorities per site
- Prepares for and conducts on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites as required by clinical monitoring plan
- Takes the initiative to move the project/program forward by reducing backlog and keeping it at a minimum
- Monitors with knowledge of quality/scope/timeline and budget parameters
- Works with the Clinical Manager (CM), Clinical Lead or equivalent to enhance and proactively manage site visits and trial issues during the monitoring phase
- Monitors the quality of clinical deliverables and addresses quality issues with the appropriate team member. Escalates appropriately and in a timely maner to the appropriate team member
- Manages query resolution process with sites and Premier Research Data Management
- Maintains Trial Master File (TMF)/electronic Trial Master File (eTMF) as defined by the organization’s processes per filing guidelines. Has an understanding of the required essential documents according to ICH/GCP Section
- Reviews site documents and verifies they are accurate, complete, current, and include required updates
- Assists project team with assessing project feasibility and recruitment, as applicable
- Maintains project tracking system of subjects and site information, as applicable
- Participates in Investigators’ Meeting as designated by the Project Manager
- Maintain communication with study sites as directed per CMP, and in agreement with the study site and complete documentation of contacts
- Attends meetings as required
- Ensures site visit metrics and utilization are maintained as required and escalates available time as necessary to line manager
- Completes timely entry of hours worked and project codes per time entry guidelines
- Maintains high level of attention to detail to ensure subject safety for our projects and delivery of quality data for our clients
- Acquire basic knowledge of disease or condition under study. Participates in available training offered to increase therapeutic knowledge
- Review of IP accountability and applicable logs (subject and site level) as directed per the Clinical Monitoring Plan
- Maintains proper, timely communication with study teams and management, as needed
- Completes all required internal training (general and study-specific) on-time
- Identifies confidential information and complies with global and local laws and guidelines
- In specific countries or situations, the CRA may be requested to also assume additional country specific responsibilities, being appointed as Subject Matter Expert in one or more areas including but not limited to the following: Start-up, Regulatory, Site Contracts, Office Manager, etc. This will be documented with the appropriate guidance or functional description
- In specific projects, the CRA may be requested to also assume additional project specific responsibilities, e.g. Clinical Management for smaller or less complex studies, under the appropriate supervision of the line manager or functional lead
- Other activities as designated
- Acts as a resource for other CRAs and shares knowledge base and best practices.