Clinical Research Associate (CRA) - Portugal
Syneos Health is a leading fully integrated biopharmaceutical solutions organization, built to accelerate customer success. We are looking for an experienced Clinical Research Associate (CRA) to join our dynamic team in Portugal. This is an exciting opportunity to be part of a global organization that brings the customer and the patient to the center of everything we do.
Why Syneos Health
At Syneos Health, we are passionate about developing our people, fostering career development, and offering a supportive environment. Our Total Self culture is key to uniting us globally, and we prioritize diversity of thoughts, backgrounds, and perspectives to build a place where everyone belongs.
We’re committed to simplifying our work processes, ensuring collaboration, and achieving great outcomes for our customers while innovating as a team.
Job Responsibilities
Site Management: Perform site qualification, initiation, monitoring, and close-out visits (on-site or remotely) to ensure compliance with regulatory standards, ICH-GCP, and the study protocol.
Informed Consent & Data Integrity: Ensure informed consent processes are adequately followed and documented. Assess factors that could impact subject safety and data integrity.
Clinical Data Review: Review source documents, verify clinical data entered in case report forms (CRFs), and resolve queries in a timely manner.
Investigational Product (IP) Management: Verify the handling of investigational products (IP), ensuring proper dispensing, storage, security, and compliance with protocol requirements.
Regulatory Compliance: Regularly review the Investigator Site File (ISF) for accuracy and completeness. Ensure all essential documents are archived according to local regulations.
Training and Communication: Provide training and support to site personnel to ensure compliance with study requirements. Serve as a liaison between site staff and the study team, ensuring effective communication and coordination.
Project Management: Ensure timely delivery of project milestones by managing site-level activities, communication, and issue resolution.
Qualifications
Education: Bachelor’s degree in a related field (RN or equivalent education/training also acceptable).
Experience: Prior monitoring experience in Portugal and knowledge of Good Clinical Practice (GCP)/ICH Guidelines.
Skills: Strong computer skills, excellent communication, and interpersonal skills. Proficiency in Portuguese and English required.
Travel: Ability to manage required travel for monitoring visits.
Regulatory Knowledge: Good understanding of regulatory requirements and the ability to manage clinical study documentation accurately.
About Syneos Health
Over the past 5 years, Syneos Health has worked with 94% of all novel FDA-approved drugs, 95% of EMA authorized products, and conducted over 200 studies across 73,000 sites. We are dedicated to transforming the clinical trial experience for our clients, offering innovative solutions to accelerate drug development and improve patient outcomes.
Additional Information
This job description may be subject to changes and other tasks may be assigned as necessary. Syneos Health is an equal opportunity employer, committed to diversity and inclusion in the workplace. We provide accommodations for individuals with disabilities and comply with all applicable employment laws.
Interested in this opportunity? Join Syneos Health, where WORK HERE MATTERS EVERYWHERE.
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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