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Senior Clinical Research Associate I (FSP)

Austria - Any Region - Home Based Date posted 02/07/2021 Job ID 66192BR

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

ExecuPharm a PAREXEL company is a contract research organization (CRO) that provides clinical research support services to companies from the pharmaceutical industry.

Our client is a large and rapidly expanding biotechnology company with headquarters in the Pacific Northwest and Switzerland with 1,600+ passionate employees helping people with cancer with targeted treatment has a need for an experienced Senior Clinical Research Associate in Austria.

Role Overview:

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.
There may also be the opportunity to contribute to other clinical trial related activities, including vendor management, data review, or other study-related in addition to identifying and qualifying potential investigators.

Major Responsibilities:
  • Act as liaison between the in-house team, vendors, and multiple clinical sites.
  • Work collaboratively with investigative sites to develop strong, long-term, working relationships.
  • Apply SOPs, Clinical Monitoring Plan (CMP), study manuals and other materials and guidelines as applicable.
  • Help identify and qualify potential investigators. Perform Pre-Study Site Visits.
  • Assist with start-up activities, including essential document review and collection as requested.
  • Perform site visits through initiation, monitoring to close out as required.
  • Provide initial and ongoing training to site personnel regarding the study protocol, applicable policies/procedures, and GCP.
  • Prepare and submit visit trip reports, confirmation and follow up letters within timelines outlined in the CMP.
  • Work proactively with sites to address site issues and action items to obtain swift resolution and escalate to Client/site per CMP.
  • Contribute to the preparation and follow-up of on-site sponsor quality audits and regulatory authority inspections as assigned.
  • Adhere to CFR, GCP/ICH, company policies, Clinical Operations and project specific quality documents (e.g. SOPs, work practices, training guides).

Qualifications

Qualifications :

More about you
  • Oncology TA area experience.
  • BA/BS, or equivalent, or relevant experience and training with at least 3 years independent CRA experience - all types of visits.
  • Able and willing to travel approximately up to 55-75%. Travel requirements will vary depending on study requirements, site assignments, site remote monitoring capabilities, and geographical location.
  • Must be fluent in English.

A little about us

For over 30 years, we at Execupharm have been an industry leader in providing innovative, flexible and customized outsourcing solutions. Our Functional Service Provider (FSP) team was established to help clients accelerate pipeline development.
With over 5,000 Global FSP resources, with an additional 25,000+ pre-screened potential candidates in our system, we are available to partner with you to provide tailored solutions that address your unique needs.

Why Work at Parexel

There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?
That’s Parexel. We’re a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

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