Parexel Hiring CLINICAL RESEARCH ASSOCIATE II Bachelor’s or equivalent degree in biological science, Pharmacy or other health related discipline
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More about you
On your first day we’ll expect you to have:
Site Management or equivalent experience in clinical
research, with understanding of clinical trials methodology and terminology.
Ability to perform all clinical monitoring activities
independently.
Bachelor’s or equivalent degree in biological science,
pharmacy or other health related discipline.
Strong interpersonal, written, and verbal communication
skills within a matrixed team.
Experience working in a self-driven capacity, with a sense of
urgency and limited oversight.
A client-focused approach to work and flexible attitude with
respect to assignments/new learning.
The ability to manage multiple tasks, evaluate a variety of
unpredictable scenarios and achieve project timelines while being able to apply
your understanding of study protocol(s).
An honest and ethical work approach to promote the
development of life changing treatments for patients.
Strong computer skills, including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS) and MS-Office products such as Excel and Word.
What you’ll do
Leverage your expertise. Conduct qualification visits (QV), site
initiation visits (SIV), monitoring visits (MV) and termination visits (TV) at
assigned clinical sites and generate visit/contact reports.
Build relationships. Oversee integrity of the study and
utilize problem-solving skills to promote rapport with the site and staff.
Protect patients. Review the performance of the trial at
designated sites, ensure the rights and well-being of human subjects are
safeguarded and are in accordance with protocol.
Drive productivity. Develop patient recruitment strategies in
conjunction with the clinical site to meet enrollment timelines, while also
ensuring compliance with the approved standard operating procedures (SOPs),
protocol/amendment(s), GCP, and the applicable regulatory requirement(s).
Ensure quality. Evaluate the quality and integrity of the
reported data, site efficacy and drug accountability.
Execute. Monitor the completeness and quality of Regulatory Documentation and perform site document verification.
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