Job Information
ThermoFisher Scientific Assistant CRA - Belfast in Remote, United Kingdom
Work Schedule
Other
Environmental Conditions
Office
Job Description
Assistant CRA - Belfast (Home based)
We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD clinical research services, thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health.
We are currently hiring for an Assistant CRAs to join our UK Clinical Operations team, working home based in Belfast.
This role is suitable for candidates looking to grow in to a travelling CRA position in the future and provides excellent development opportunities.
You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients. Our global Clinical department consists of colleagues with institutional knowledge, in-depth therapeutic experience, and robust operational tools. Together, we help clients define and develop clinical programs, minimize delays and execute high-quality, cost-efficient clinical studies.
As an Assistant CRA (ACRA), you combine knowledge, therapeutic expertise, and robust tools to help our clients deliver life-changing therapies to market. You take ownership, anticipate problems, find solutions, and deliver results.
At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.
Summarized Purpose:
The ACRA Performs remote activities on assigned projects in liaison with CRAs and the study CTM. This role provides support with regards to site preparedness, logistical support to the monitoring process, and assists with assigned tasks for site management and remote monitoring.
Essential Functions:
Completes study and site management activities
Completes and documents study-specific training
Orients and trains on any company/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 staff training, as applicable
Coordinates and supports logistics for Investigator Meeting attendance
Support with maintenance of vendor trackers
Coordinates study/site supply management
Supports Essential Document collection, review and updating in systems, as applicable
Follow up and supports on missing study vendor data like ECGs, lab samples, and e-diaries
Supports ongoing remote review of centralized monitoring tools
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
Verifies document collection status in company systems and drives action for missing/incomplete/expired documents and open document findings
Education and Experience:
Bachelor’s Degree in a life science-related field or relevant/equivalent formal academic/vocational qualification
Previous Clinical Research Experience
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.
Knowledge, Skills and Abilities:
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
Strong attention to detail
Ability to work in a team or independently, as required
Well-developed critical thinking skills,
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
Full, clean UK driving licence
Full right to work in the UK indefinitely
Willingness to travel in the future in the role of on site CRA
Working Environment:
PPD clinical research services values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive
e support and encourage individuals to create a healthy and balanced environment where they can thrive.
Our 4i Values: Integrity – Innovation – Intensity – Involvement
If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application – we’d love to hear from you!
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.
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