Job Description

This role will be office based in Warsaw. This is close to the airport as well as the town centre.

An ideal candidate will be passionate about clinical research and ready to develop their professional career towards a Clinical Research Associate role in 6-12 months.

As the Clinical Operations Assistant (COA) you will maintain the paper and electronic Central Files for Clinical Operation, ensuring efficiency, accuracy and quality. Depending on the location of the role may include the tracking, scanning, filing, entry and return of Case Report Forms to clients for assigned projects, upload and naming of documents to the electronic document management system, EDC User Management activities and activities associated with Impact Harmony, as appropriate. You will also support all site management team members on local billable administrative tasks and assist with QC of Central files. This is an excellent entry level role into clinical operations and will allow for future development into either of our monitoring or study start up teams.

Key Accountabilities:

Project Central Files & Clinical Trial Management Systems Maintenance and Updates.

Track, scan, code, and apply naming convention and send documents to the relevant study Work In Progress (WIP) area and Central File (CF) area of PMED as per the Central File Maintenance Plan.

Filling and Archiving paper wet-ink documents in the Central Files office location as per the Central File Maintenance Plan (CFMP).

Photocopy, print distribute and retrieval of documents, as needed.

Maintain basic quality check procedures to ensure accurate maintenance of documents.

Tracking/maintenance of the Clinical Trial Management System (CTMS) and study specific site trackers (Client additional request only).

Monitoring of the status of systems and processes (e.g. annual reporting obligations, Site Compliance regarding Safety Information System (SIS) etc.) to ensure compliance.

Support to all local site management team members (CRA).

Organization of translations of study document (e.g. contacting translation company, requesting approval via Oracle, following up with translation company to ensure timely delivery).

Payment/invoice processing including internal follow up with payment specialists in Finance.

Courier shipment of study document to the sites, vender and clients.

Collection of internal signatures for site documents (e.g. confidentiality agreement or clinical site agreements) within Parexel.

Qualifications

An ideal candidate will possess:

A degree in the life sciences.

Some initial clinical research or clinical operations experience in either pharma, CRO or academia is essential.

Fluent English and Polish is a must.

Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word.

Maintain a basic knowledge and ensure compliance with applicable ICH-GCP Guidelines.

Excellent oral and written communication skills.

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.