Job Description

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 requirementswillvary 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 atExecupharm 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.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.

How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.