Company: Premier Research
Reference: Senior CRA - Australia
Closing Date: 26 Oct 16
Type: Full Time
Salary (£): Competitive
Premier Research helps highly innovative biotech and pharma companies transform life-changing ideas into reality. We are positioned right in the middle of the action, targeting unmet needs in analgesia, neuroscience, oncology, paediatrics, and rare diseases.
We’re looking for a talented and energetic Senior Clinical Research Associate to join our team, working on interesting studies, contributing to the start-up processes and sharing experience to contribute to local business growth.
This is an exciting opportunity to join a dynamic and innovative CRO. You will be responsible for performing clinical trial monitoring activities and have some involvement in start-up activities in compliance with trial protocol, ICH-GCP, applicable local laws and regulations, company policies and quality standards.
You will manage study-site activities to ensure collection of accurate clinical data within prescribed timelines; identify, resolve, mitigate, and escalate risks and issues; take responsibility for multiple studies; and work independently with team support. This role will be fully home-based, supported by an Australian manager.
Candidates will ideally be located in either Melbourne, Brisbane, Adelaide or Sydney so they are near an airport and the East coast where most of the site are.
You’ll be accountable for:
Delivering high-quality, timely monitoring reports for sponsor approval per Clinical Monitoring Plan timelines.
Scheduling site visits for monitoring as required by protocol monitoring visit windows.
Ensuring the validity, correctness, and completeness of clinical data reviewed and collected at assigned sites as dictated by trial protocol, ICH-GCP/ISO 141155, and customer requirements.
You’ll be responsible for:
Monitoring data — remotely, on site, and via other approved modes — with a focus on data integrity and patient safety, in accordance with specific country regulations.
Planning day-to-day activities for study monitoring and setting priorities by site.
Preparing for and conducting qualification, study initiation, interim monitoring, and close-out visits at investigator sites.
Working with the line manager and CM to ensure that visit metrics are maintained as required.
Gauging the quality of clinical deliverables and addressing quality issues with team members.
Providing accurate and timely trip reports and records of hours worked.
Managing query resolution with study sites and Premier Research data management operations.
Maintaining the project tracking system of subjects and site information.
Participating in Investigators’ Meetings as assigned by Project Managers.
Maintaining contact with investigator sites via telephone calls between visits.
Ensuring adherence to study timelines and budgets.
Identifying and escalating potential risks and identifying retraining opportunities for site study teams.
You’ll also contribute by:
Being a resource for other CRAs, mentoring junior-level staff and sharing knowledge and best practices.
Participating in training offered to increase therapeutic knowledge and keeping current with regulations and TGA guidance.
In specific countries or situations, assuming country-specific responsibilities and/or being named a subject-matter expert in one or more areas; e.g.: start-up, regulatory, site contracts, office management.
Assuming additional duties on certain projects, such as clinical management for smaller or less complex studies.
You’ll need this to be considered:
Education: Undergraduate degree or its international equivalent in clinical, science or health related field from an accredited institution or a licensed healthcare professional
Fluent verbal and written English
Previous CRA / independent monitoring experience essential
Experience of start up activities ideal
Working knowledge of Australian and international regulatory procedures, and monitoring activities
Excellent team player, collaborative and able to build an effective team.
Ability to multitask and work effectively in a fast-paced environment
Excellent organizational and time-management skills, able to prioritize work to meet deadlines
Accountable, dependable and strong commitment
If you are looking for a career within a transparent and non-hierarchical organisation then please contact us at the email address listed below. We are open minded and flexible regarding the talent we recruit, ultimately we are looking for people who will share in our vision and realise the importance of communication, building relationships and adhering to the highest quality standards.
You must be eligible to live and work in Australia in order to apply for this role
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