Senior CRA
2 semanas atrás
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 is rapidly growing, and we are looking for an experienced CRA to join our local team in Portugal. This opportunity could be hybrid/office based in Lisbon, or homebased anywhere in Portugal.
A day in the Life:
1. Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify any risks/issues. Ensures data accuracy through SDR, SDV and CRF review.
2. Assesses investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues as needed. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.
3. Provides trial status tracking and progress update reports to the CTM as required. Ensures study systems are updated per agreed study conventions. Performs QC check of reports generated from CTMS system where required.
4. Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulations.
5. Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
6. Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members. Performs additional study tasks as assigned by CTM.
7. Facilitates effective communication between investigative sites, the client company and the internal project team. Contributes to other project work and initiatives for process improvement, as required.
Keys to Success:
University degree in a life-sciences field
Minimum 3 years of independent, on-site monitoring experience in a Pharmaceutical or Clinical Research Organisation as a Clinical Research Associate
Knowledge, Skills, Abilities:
- Solid understanding of ICH-GCP, EU and FDA requirements
- Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
- Outstanding communication, collaboration, organisational and time management skills
- Fluency in both Portuguese and English languages is essential
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 both expertly 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.
Please note that if you are NOT a passport holder of the country for the vacancy you might need a work permit. Check our Blog for more information.
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