Offer summary

Qualifications:

Minimum of 3 years of experience as a clinical monitor (CRA) with onsite monitoring experience in Turkey., Bachelor’s degree or Registered Nurse (RN) in a related field or equivalent education and experience., Experience managing complex protocols in Oncology or high-risk therapeutic areas., Familiarity with systems like Siebel CTMS, eTMF, and eISF..

Key responsabilities:

Ensure data integrity, quality, and compliance with ICH GCP and local requirements at the site level.

Conduct monitoring in line with the Study Monitoring Plan (SMP), primarily through virtual activities.

Collaborate with the Site Manager to maintain protocol adherence and site inspection readiness.

Coordinate with local institutions and investigators to facilitate study processes.

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.

Parexel FSP is currently hiring for a home-based Site Monitor II.

Single sponsor dedicated to a worldwide biopharmaceutical company that relentlessly seeks breakthroughs to improve patients’ lives. Their daily innovation contributes to a healthier global community. This is the space where today’s visionaries, solution-seekers, and trailblazers converge to shape tomorrow’s groundbreaking solutions. Together, we have the power to revolutionize patients’ well-being. Every choice and step we make is guided by our unwavering focus on patients, fostering an environment where innovation thrives.

The Site Monitor will be responsible for data integrity, data quality and ensuring compliance with ICH GCP and local requirements at the site level. Monitoring will be conducted in line with the Study Monitoring Plan (SMP) and will be performed virtually for most activities to supplement on-site visit requirements. The Site Monitor will collaborate with the Site Manager to ensure that the site follows the protocol and is inspection ready and will coordinate with institutions and investigators at the local level.

Experience required:
•   A minimum of 3 years of experience as a clinical monitor (CRA) with demonstrated experience of monitoring onsite in Turkey. A combined experience of INCRA and onsite CRA will also be considered.
•   Experience in managing complex protocols in Oncology or other therapeutic areas (TAs) where protocols are determined to be high risk:
•   Bachelor’s degree or Registered Nurse (RN) in a related field or equivalent combination of education, training, and experience
•   Experience in utilizing systems like Siebel Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF), electronic Investigational Site File (eISF) (Florence)

We offer exceptional financial rewards, training, and development. Expect exciting professional challenges but with a healthy work/life balance. We value your welfare just as highly as that of our patients.

Apply today!

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