Clinical Research Coordinator

Company
PAREXEL
Location
Harrow, England,United Kingdom
Salary
Competitive
Posted
27 Nov 2018
Closes
02 Feb 2019
Ref
49420BR
  • Accountable for the planning and execution of clinical trials in conjunction with the Project Manager, Principal Investigator, Clinical Operations and other relevant departments according to the study protocol, ICH GCP guidelines and applicable SOPs
  • To assist in the conduct of Phase 1 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 continuously improve standards of all aspects of study set up
  • Ensure studies are prepared to the highest standard, within the specified timelines
  • The CRC must also coordinate with different departments and where applicable external parties to streamline operations, ensure appropriate allocation of resources and produce high quality and accurate data
Key Accountabilities:
  • Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner.
  • Accountable for the planning and preparation of clinical trials in conjunction with the Project Manager, Principal Investigator Clinical Operations and other relevant departments, according to the study protocol, ICH GCP guidelines and applicable SOPs.
  • Ensure all studies are set up as per internally defined standard, as per study protocol and along GCP requirements.
  • Review protocols, study reference manuals, CRF for clarity and feasibility and attend and participate in study related meetings.
  • Create the study summary and restriction forms.
  • Create any required source data or work sheets.
  • Create the Window Allowance Agreement for time variations in conjunction with the client and as per internal standard.
  • Develop Source Data Verification in conjunction with Project Management and the client. Prepare the slideshow for the internal study training meeting in conjunction with responsible Research Nurse or Research Assistant.
  • Review the Ward Schedule that is compiled by the Research Nurse or Research Coordinator and feedback comments.
  • Taking on the leadership of developing the ClinBase set-up in conjunction with Pharmaceutical services, Laboratory, Clinical Operations and other relevant departments.
  • Review the ClinBase set up, and ensure compliance with the Protocol and other study documentation.
  • Provide oversight and presence on the Clinical floor and support, as needed.
  • Taking ownership during and after study conduct, to ensure that all data related deliverables and milestones are met within the required time frame per project, including but not limited to Database Lock.
  • Any other duty as requested by Clinical Management.
QualificationsSkills:
  • 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.

Knowledge and Experience:
  • Strong experience in the practical conduct of clinical trials.
Education & Qualifications:
  • Scientific Qualification or Registered Nurse.
Skills:
  • 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.

Knowledge and Experience:
  • Strong experience in the practical conduct of clinical trials.
Education & Qualifications:
  • Scientific Qualification or Registered Nurse.

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