Senior Clinical Research Associate
Há 1 mês
We are seeking an experienced Senior Clinical Research Associate to join our team in Portugal. As a key member of our Clinical Operations team, you will be responsible for monitoring investigator sites, ensuring data accuracy, and providing trial status tracking and progress update reports to the CTM.
Key Responsibilities- Monitor investigator sites with a risk-based monitoring approach, applying root cause analysis, critical thinking, and problem-solving skills to identify any risks/issues.
- Ensure data accuracy through SDR, SDV, and CRF review.
- Assess investigational product through physical inventory and records review.
- Document observations in reports and letters in a timely manner using approved business writing standards.
- Escalate observed deficiencies and issues as needed, ensuring a shared responsibility with other project team members on issues/findings resolution.
- Investigate and follow-up on findings as applicable.
- Provide trial status tracking and progress update reports to the CTM as required, ensuring study systems are updated per agreed study conventions.
- Perform QC check of reports generated from CTMS system where required.
- Participate in investigator meetings as necessary, identifying potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.
- Initiate clinical trial sites according to relevant procedures to ensure compliance with the protocol and regulations.
- Ensure that required essential documents are complete and in place, according to ICH-GCP and applicable regulations.
- Conduct on-site file reviews as per project specifications.
- Contribute to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.
- Perform additional study tasks as assigned by CTM.
- Facilitate effective communication between investigative sites, the client company, and the internal project team.
- 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.
- 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.
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.
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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