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 hiring a Clinical Study Team Assistant II to join our team in LATAM. The position will be remote.
The Clinical Study Team Assistant II (CSTA II) is an essential part of the Core Study Team and is responsible for driving and/or supporting key clinical trial tasks for assigned studies to ensure compliance with ICH-GCP, SOPs, and regulatory regulations. The role collaborates with global study team members and is responsible for multiple tasks that span from study start-up to study close-out which enables the efficient execution of clinical trials to high quality standards.
Provides study level operational support to the Core Study Team from study start up to close out and submission:
o Management and oversight of Study Team shared spaces
o TMF maintenance, compliance, and oversight
o Management and oversight of Study Management Platform
o Registry and/or Clinical Trial Management system(s) compliance and maintenance
o Tracking and oversight of study level information; follow up with functional lines as needed
o Liaising with cross functional study team members:
o Quality Control (QC) of essential clinical trial, Clinical Study Report (CSR) and regulatory submission documentation
o Manages engagement of Independent Oversight Committees
o Provides support to the CSTL and Clinical Quality Lead with Inspection Readiness Activities
o Assists the CSTL with oversight and tracking of Clinical Trial Budget spend
o Provides logistical/operational support to Study Management for Investigator Meetings
o Provide training to new hires
o Mentor new hires and junior CSTAs
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 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.
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