Overview
Experienced Clinical Research Associate (Renal, Transplant and / or Nephrology) Sweden / Norway at Thermo Fisher Scientific. This role focuses on clinical monitoring and site management in renal, transplant and / or nephrology programs, across diverse sponsors and monitoring environments.
Your Role
- Performs and coordinates all aspects of the clinical monitoring and site management process in compliance with the approved protocol and Monitoring Plan.
- Conducts remote or on-site visits to assess protocol and regulatory compliance and handles required documentation.
- Manages procedures and guidelines from different sponsors and / or monitoring environments (e.g., FSO, FSP, Government).
- Develops collaborative relationships with investigational sites.
- Acts as a site Manager and processes specialist, ensuring trials are conducted in accordance with the protocol, ICH-GCP, applicable regulations and SOPs to protect subjects and ensure data reliability.
- Ensures audit / inspection readiness.
- Other detailed tasks and responsibilities will be outlined in the task matrix.
Requirements and Qualifications
Bachelors degree in a life sciences field or a Registered Nursing certification or equivalent; alternative combinations of education, training and / or related experience may be considered.Valid driverrs license.Effective clinical monitoring skills with at least 1 year of monitoring experience.Excellent oral and written communication skills in local language and English.Ability to travel and perform 8 days on site per month on average.Understanding of medical / therapeutic area knowledge and medical terminology.Strong knowledge of ICH-GCP, applicable regulations and procedural documents.Ability to handle Risk Based Monitoring concepts and processes.Strong attention to detail and time management skills.Proficient computer skills (Microsoft Office) and ability to learn relevant software.Good presentation skills.Please submit your CV in English.About Thermo Fisher Scientific
Our mission is to enable our customers to make the world healthier, cleaner and safer. We are a global team of 100,000+ colleagues who share values of Integrity, Intensity, Innovation and Involvement, working together to accelerate research and support patients in need. Thermo Fisher Scientific is an EEO / Affirmative Action Employer and does not discriminate on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Company Highlights
Recognized for excellence in multiple categories in the 2023 CRO Leadership Awards and related distinctions.Multiple industry and safety awards and acknowledgments across the last few years.Note : This role is currently seeking Experienced CRAs throughout Sweden or Norway with renal, transplant and / or nephrology experience. No entry-level CRA roles are available at this time.
Reasons to apply : Learn more about PPD (Thermo Fisher Scientific Clinical Research) and how we support patients, clinicians and researchers worldwide.
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