26 sep
|
Arcadis
|
España
We are looking for a motivated Clinical Research Associate (CRA) to support the successful execution of clinical studies within an innovative MedTech environment. In this role, you will be responsible for monitoring clinical trial activities across multiple study sites, ensuring compliance with study protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines.
You will work closely with investigators, study coordinators, and Clinical Operations teams to drive study performance, maintain data quality, and contribute to the successful delivery of clinical research projects.
Responsibilities
- Manage and monitor assigned clinical study sites across one or more clinical projects.
- Conduct site initiation, routine monitoring, and close-out visits.
- Ensure the safety, rights, and well-being of study participants.
- Support the operational execution of clinical trials and ensure high-quality data collection.
- Verify compliance with study protocols, GCP guidelines, and applicable regulatory requirements.
- Review and maintain Investigator Site Files (ISF) and essential study documentation.
- Support patient recruitment and retention activities at study sites.
- Identify, escalate, and help resolve study-related issues, including implementation of corrective and preventive actions (CAPAs).
- Collaborate with investigators, ethics committees, vendors, and internal stakeholders.
- Assist in organizing investigator meetings, study trainings, and process improvement initiatives.
- Provide timely updates on site performance,
study progress, and potential risks.
- Support the implementation of new clinical systems and processes when required.
Profile
- Bachelor's or Master degree in Life Sciences, Biological Sciences, Nursing, Pharmacy, Biomedical Sciences, or a related field.
- Minimum 2 years of relevant clinical research experience with a Bachelor's degree, or 1 year of experience with a Master's, PhD, MD, or PharmD degree.
- Previous experience in clinical research is required.
- Experience with Medical Device studies or clinical monitoring is highly preferred.
- Good understanding of ICH-GCP guidelines and clinical research regulations.
- Strong communication and relationship-building skills.
- Excellent organizational skills with the ability to manage multiple priorities and deadlines.
- Proficient in Microsoft Office applications (Word, Excel, and PowerPoint).
- Relevant certifications such as CCRA, RAC, or CDE are considered an asset.
- Clinical or medical background is a plus.
- Fluency in English, both written and spoken.
- Willingness to travel up to 80% of the time.
What We Offer
- An exciting opportunity within a leading MedTech organization.
- Exposure to innovative clinical research projects with integral impact.
- A collaborative and international working environment.
- Opportunities for professional growth and development.
- Competitive salary package with attractive benefits.
- High level of responsibility and autonomy within clinical study teams.
📌 Clinical research associate (España)
🏢 Arcadis
📍 España