Assistant CRA
4 semanas atrás
Job Description
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.
Our global Clinical Operations colleagues within our PPD clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.
Our Clinical Operations team Portugal is growing, and we are currently looking for an Assistant CRA.
The main responsibilities include, but are not limited to:
• Completes study and site management activities as defined in task matrix, and as applicable and directed for study assigned
• Completes and documents study-specific training. Orients and trains on any CRG/study-specific systems
• Provides in-house support during pre-study assessments
• Reviews study data from various sources remotely
• Supports site staff, where applicable
• Supports Essential Document collection, review and updating in systems
• Verifies document collection status and drives action for missing/incomplete/expired documents and open document findings, as directed
Education and Experience:
Bachelor's Degree in a life science-related field or relevant/equivalent combination of education, training and experience that provides the individual with the required knowledge, skills, and abilities.
Prior clinical research experience (comparable to 1 year) would be preferable, as well as, knowledge of clinical monitoring through classwork/training that provides the required knowledge skills and abilities.
In some cases, previous experience in a clinical environment where experience is gained in clinical trials, data management, medical terminology, medical research or health care or experience in a health sciences field with formal training in medical terminology and anatomy may be considered.
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 PPD clinical research services procedural documents
• Effective oral and written communication skills. Fluency in English and Portuguese language is essential
• 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
• Ability to work in a team or independently, as required
• Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving.
• Proficient computer skills with good knowledge of MS Office ability to learn and use appropriate software.
• Ability to extract pertinent information from all study documents, electronic study data systems, CTMS and dashboards
Why Join Us?
We hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow bothexpertly and personally throughout your career, and therefore will benefit from an award-winning learning and development programme, ensuring you reach your potential.
What We Offer:
As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD clinical research services truly value a work-life balance. We've grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
How to apply: Please submit your CV in English.
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