Key Facts

Remote From:

Full time

Senior (5-10 years)

Spanish, Italian

Hard Skills

Oncology Website Monitoring Neurology Regulatory Compliance Protocol Analysis Project Status Reports Digital File Management General Surgery Clinical Trial Planning Informed Consent Clinical Monitoring

Other Skills

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Social Skills
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Time Management
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Detail Oriented
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Self-Motivation

Roles & Responsibilities

Bachelor's degree in a life science or related discipline
Minimum of 5 years' experience in independent site monitoring
Oncology/Neurology experience
Fluent Spanish and Italian

Requirements:

Independently set up and oversee a study, complete study status reports, and maintain study documentation
Participate in submission of protocols and consent documents for ethics/IRB approval, and assist in preparation of regulatory submissions as requested
Ensure ICH GCP compliance and oversee study activities across sites in oncology/neurology
Travel domestically and internationally approximately 65-75% of working time to monitor sites

Parexel

Pharmaceuticals

About Parexel

Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.

Company type: XLarge

Industry: Pharmaceuticals

Founded: 2018

Company size: 10001

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Job description

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Do you know why we are one of only three CROs to have received the Leadership Award for 11 consecutive years? Because we appreciate our team, whose dedication and commitment to excellence is reflected in this award, and we work with heart, keeping the patient at the center of everything we do.

Join our team and develop your career with us by contributing your personal and professional talents and skills. Together we will continue to do things that matter to people.

Parexel FSP is looking for a Senior Clinical Research Associate in Spain with Spanish and Italian to strengthen our clinical operations team. Work from home and with the flexibility you want. Our SMs have less travel and less workload to maintain work-life balance. We offer long-term projects, world-class technology and training tailored to your individual experience.

As a SM, you will work independently and will be responsible for all activities required to set up and oversee a study, complete study status reports, and maintain study documentation. You will participate in the submission of protocols, consent documents for ethics/IRB approval and assist in the preparation of regulatory submissions as requested.

You will have the opportunity to be a unique sponsor dedicated to one of the top 10 pharmaceutical companies in the world, working on oncology studies that deliver real impact.

You will possess:

Bachelor's degree in a life science or related discipline.
Minimum of 5 years' experience in independent site monitoring.
Oncology / Neurology experience.
Fluent Spanish and Italian.
Understanding of ICH GCP Compliance.
Excellent time management and social skills
Highly motivated with a phenomenal eye for detail.
Ability to travel domestically and internationally approximately 65%-75% of working time. Expected travelling ~2-3 days/week
Current driver’s license required

Send me your updated resume to marta.kuniewicz@parexel.com for an immediate interview.