Clinical Research Associate II - FSP - France
6 days left
- Experience Level
- Experienced (non-manager)
Single sponsor dedicated.
Sponsorship is NOT available.
Everything we do has the potential to impact patient lives, and our Clinical Research Associates
(CRA) take their work seriously, demonstrate empathy, and act with heart. They also perform with urgency, navigating our streamlined clinical operating model to drive effectiveness, reduce handoffs and increase employee, client, and site satisfaction.
As a CRA at Parexel, you will be joining a team with a wide variety of experiences and knowledge. We’re looking for people like you to take the initiative to do things better and smarter people who want to grow personally and professionally. We recognize and uphold the importance of all people, the way we do things, our quest for innovation, and most importantly, our patients.
This position focuses on all activities required to evaluate, initiate, monitor and close clinical sites. This role may provide operational input to clinical study teams as directed.
Responsibilities may include:
- Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are with applicable local regulatory requirements and ICH GCP guidelines.
- Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites.
- Reviews and verifies accuracy of clinical trial data collected, either on site or remotely.
- Completes monitoring activity documents as required by SOPs or other contractual obligations.
- Escalates site and trial related issues per SOPs until identified issues are resolved or closed
- Performs essential document site file reconciliation.
- Performs source document verification and query resolution.
- Assesses investigational product (IP) accountability, dispensation, and compliance at the investigative sites.
- Verifies SAE reporting according to trial specifications and ICH GCP guidelines.
- 2+ years of clinical monitoring experience - all types of visits required.
- Knowledge of ICH and local regulatory authority regulations regarding drug preferred.
- An advanced degree (eg, MS, MBA, PharmD, etc.) preferred.
- Experience in monitoring all trial components (pre-study site visit [PSSV] to closeout visits.
- Oncology or Immunology experience desirable.
About PAREXEL FSP
A a global provider of functional service solutions across a range of specialized disciplines for clinical development and biopharmaceutical product lifecycle support including clinical operations, biometrics, safety, regulatory, medical writing, and medical affairs.
For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is the CRO trusted by life sciences companies to innovate keeping patients at the center of everything we do, and where an inclusive global community helps you be your best, transforming any career into a life-changing achievement.
For an immediate telephone interview please contact the job poster.
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