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Senior Clinical Research Associate - FSP

United Kingdom - Any Region - Home Based Date posted 08/30/2021 Job ID 72149BR

Everything we do has the potential to impact patient lives, and our Clinical Research Associates (CRAs) 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‘ll 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.

Success Profile

Check out the top traits we’re looking for and see if you have the right mix.

  • Innovative
  • Problem-Solver
  • Communicator
  • Tech-Savvy
  • Confident
  • Independent
  • "The last 4.5 years I had a steep learning curve and I am still learning via on-the-job challenges and solid management feedback. Next to my personal growth, I also enjoy our open atmosphere and the great collegiality."

    Stefanie – Sr Clinical Research Associate

Rewards

  • Global Impact

    We are one truly global team working together to propel each client´s journey ahead faster.

  • Balance

    We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.

  • Collaboration

    Work with industry leaders and subject matter experts.

  • Freedom

    The ability to innovate, ask “what if” and try new solutions without fear of failure.

  • Variety

    Opportunities to work on multiple accounts – never boring!

  • Compensation

    Competitive salaries and bonus structure based on individual metrics.

Responsibilities

Duration: Permanent

Home based - UK.

Open on TA area.

Sponsorship is NOT available.

Everything we do has the potential to impact patient lives, and our Senior Clinical Research Associates (SRA) 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 SCRA at Parexel FSP , 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.

Position Purpose:

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.

Qualifications

Experience:

  • 3 + years of clinical monitoring experience 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.
  • Monitoring such as: phase I, remote, Oncology, General Med, Immuno, etc.

About PAREXEL FSP

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.

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