Offer summary

Qualifications:

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

Key responsibilities:

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 ensure protocol adherence and site readiness for inspections.

Coordinate with local institutions and investigators to support site operations.

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 homebased SCRA/ Site Monitor I or 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 we make and every step we take 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 assure that the site follows the protocol and is inspection ready and will coordinate with institutions and investigators at the local level.

Open to Clinical Research Associates with experience of 3 + years of independent onsite monitoring, all types of visits.

A minimum of 3 years’ experience as a clinical monitor (CRA) with demonstrated experience of monitoring onsite.

Experience in managing complex protocols in Oncology or other therapeutic areas (TA’s) 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 of utilizing systems like Siebel Clinical Trial. Management System (CTMS), electronic Trial Master File (eTMF), electronic Investigator 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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