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Clinical Research Coordinator

2 months ago

Harrow, United Kingdom Parexel Full time

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
- 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**:

- A minimum of two years’ experience 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