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Clinical Research Coordinator

Employer: Parexel
Location: Harrow, United Kingdom
Salary: Competitive
Start date: 29 Mar 2023
Closing date: 28 Apr 2023

Discipline: Clinical Research, Clinical Trials Manager / Administrator
Hours: Full Time
Contract Type: Permanent
Experience Level: Experienced (non-manager)

Job Details
Company

Job Details

As a Clinical Research Co-ordinator you will be accountable for the planning and preparation of clinical trials in conjunction with the Team Leader, Project Manager and Investigator according to the study protocol, ICH GCP guidelines and unit SOPs. Assist in the conduct of Phase I -III studies across all therapeutic areas in accordance with ICH Good Clinical Practice (GCP) and following local regulatory requirements and relevant Standard Operating Procedures (SOP’s). Develop and improve continuously standards of all aspects of study set-ups. Ensure studies are prepared to the highest standard, within the specified timelines.

Planning and Execution of trial

Review protocols, study reference manuals, CRF for clarity and feasibility and attend and participate in study related meetings.
Being involved in project development, taking part in early internal project discussions
Early recognition of areas of potential problems, provide contingency plans or address the issue in an appropriate way with the required departments and give input into possible solutions
Create the study summary and restriction forms,
Create any required source data or work sheets
Compile source data verification agreement, Window allowance agreement (WAA), Normal Ranges and all required paper source documents/worksheets or other documentation (e.g. Study Summary, Work Instructions, File Notes, Working Documents, Study Schedules) as required (supervise and check draft versions i.e. lead the document compilation process)
Coordinate timely resolution of replies to internal and sponsor data queries and audit observations
Coordinate filing/archiving of study related materials appropriately away from the clinical setting once all queries resolved and database lock achieved
Monitor execution of operational aspect of studies to ensure protocol requirements are adhered to including consumables and ward set up on track.
Be present on the ward for key protocol days, and perform study related ward procedures when allocated to do so
Assess whether study specific equipment is required and conduct/coordinate a search for appropriate and cost-effective sources. Liaise with the relevant department to ensure that all required equipment is ordered, delivered and available fully functional on time for study execution
Perform research (gain appropriate knowledge) on new procedures as required (i.e. CSF sampling, arterial lines, broncho lavage) by consulting medical department, internet, hospital and take appropriate measures to ensure health and wellbeing of subjects is maintained
Coordinate timely resolution of replies to internal and sponsor data queries and audit observations
Ensure filing/archiving of study related materials is performed appropriately away from the clinical setting once all queries resolved and database lock achieved

Training

Undertake the full range of duties relevant to the leadership, management and development of the study team to ensure their study performance meets and or exceeds both the business and their own personal goals/objectives
Prepare the slideshow for the internal study training meeting in conjunction with responsible Study Lead
Keep up to date with all required training as per curriculum

ClinBase ™

Taking on the leadership of the process of developing the Clinbase set up in conjunction with Pharmaceutical services, Laboratory and ClinBase database designer and Clinical Operations
Monitor that Clinbase set up activities and ensure that it is developed within the given time
Review the Clinbase set up procure list, time windows, normal ranges
Check linkage of blood safeties as per protocol
Discussing and implementing set up changes with Quality Management and Data Management.
Check User Defined Procedures on Feasibility
Approve the set up for Clinical use to ensure study requirements are captured as per protocol and in accordance with sponsor requirements (WAA, Normal Ranges, Lab Profile, order of procedures, relative time User Defined Procedures)
Other duties as required

Skills, Knowledge & Experience:

Must be experienced in the practical conduct of clinical trials
Post-qualification experience
Excellent interpersonal, verbal and written communication skills
Client focused approach to work
A flexible attitude with respect to work assignments and new learning
Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
Willingness to work in a matrix environment and to value the importance of teamwork.
Influencing skills including negotiation and teamwork.
Ability to manage multiple competing priorities, function independently, attention to detail.
Excellent organisational skills, adaptability to change & seeing activities through to completion.
Creative with a flair for problem solving.
Literate (Word, PowerPoint, Excel)

Education:

Registered Nurse or Bioscience Qualification

Company

parexel

When you join us, you’re joining a team that sees everything they do as an opportunity to transform the world for patients everywhere. When our employees bring their many perspectives together to tackle a new challenge, there’s no limit to what they can accomplish. Through it all, at the center of all we do, is a patient whose life could change – forever. And together, we’ll do it With Heart™.

How to describe Parexel’s culture in one word:

Working With Heart™ - Christina's perspective:

Careers Blog | Our Culture | Diversity, Equity & Inclusion | Benefits | Our Hiring Process

Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help lifesaving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory, and therapeutic expertise, our team of more than 21,000 global professionals works in partnership with biopharmaceutical leaders, emerging innovators, and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere.

Company info

Website: http://www.parexel.com/
Telephone: +44 1895 238000
Location: The Quays
101-105 Oxford Road
Uxbridge
Middx
UB8 1LZ
United Kingdom

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