Company : Parexel
Job Location : Uxbridge, Hillingdon, UK
Posted on : 2021-04-14T00:51:15Z
Job Description :
Parexel is in the business of improving the world's health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do. We believe in our values; Patients First, Quality, Respect, Empowerment & Accountability.
This role will be office based at our UK Head Office situated in Uxbridge. This is close to both Uxbridge train station and the town centre and as well as this the building has plenty of free parking. The office is open planned and you will be working in an innovative and collaborative environment. Please note due to the current pandemic you would be working from home until the office fully reopens.
As the Clinical Operations Assistant (COA) you willmaintain 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.
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 (CMS)
-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
- 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 required.Qualifications
-Relevant qualification or equivalent experience required
-High school diplomaaccepted but ideally a degree in thelife sciences or other related backgroundis desirable.
-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, international and local regulations and applicable Parexel procedures
-Good oral and written communication skills to internal and external customer
-Ability to prioritize multiple tasks and achieve project timeline
-High commitment to and performs consistently high quality work
-Good written English skills
Knowledge and Experience:
-Basic previous clinical research or clinical operations experience in either pharma, CRO or academia is essential
- Experience in office management or administration in an corporate working environment would be desirable
- Strong previous office administration skills are essential
- Strong use of MS Word, Excel, PowerPoint
In return we will be able to offer you a structured career pathway and development within the role including awareness and understanding of the industry. Your hard work will be rewarded with a competitive base salary anda benefits package including 25 days holiday per year, a strong contributory pension scheme, life assurance, long term disability insurance, private medical and private dental cover as well as other leading edge benefits that you would expect with a company of this type.
Apply today to begin your Parexel journey!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 .