Clinical Operations Assisstant

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

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

Overall Accountabilities:

- Assumes the ability to meet the requirements of a COA with a high degree of proficiency

- Effective time management in order to meet daily metrics or team objectives

- Able to work independently but seek guidance when necessary, escalating issues as requiredQualifications Ideal candidate will possess:

- A degree in the life sciences.

- Basic previous clinical research or clinical operations experience in either pharma, CRO or academia is essential - 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 to internal and external customer

- Fluent English and Polish