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Senior Clinical Data Coordinator

2022-04-29 08:46:482022-05-26 Pop Science
Job Type Permanent Full Time
Location London
Area Central London, UK Central London UK London
Sector Science
Salary £35k - 45k per year
Currency gbp
Start Date ASAP
Advertiser remoteapi
Job Ref 1211
Job Views 238
Description

We've got a great role for a clinical trial co-ordinator to work in study start up at a drug development unit in Central London. You will manage the coordination and completion of essential trial documentation, with a focus on completing the trial-set up activities for the unit.

Working hours/week, Monday-Friday 9am-5.30pm

Duties and Responsibilities

Documentation

  • Collate essential site documents required prior to site activation
  • Manage the creation, maintenance and archiving of the Investigator Site File (ISF)
  • Maintain and track clinical trial documentation ensuring they meet GCP standards
  • Coordinates the preparation of ISFs for Sponsor monitors, auditors and inspectors
  • Create and complete tracking documentation as applicable
  • Compile study documentation and reports as requested by the Sponsor

Regulatory

  • To Prepare submissions and amendments to R&D, IEC and ARSAC
  • To circulate amendment information to the team e.g., updated information sheets, study documentation etc.
  • To prepare documentation for the review of studies.

Coordination

  • Be the main point of contact for the Sponsor during study set-up.
  • Plan and coordinate Sponsor initiated pre selection and site initiation visits
  • Ensure the delivery of equipment, investigator site files and other required study supplies prior to site activation.
  • Organise and request required staff accesses for the study portals.
  • Give regular updates about the status of studies in set-up and inform the team once the study has been activated at site.
  • Lead preparation of monitoring visits with external sponsors and initiate resolution of queries
  • Assist in responding to enquiries from clinical trial sponsors and other organizations
  • To understand the relevant study specific protocol requirements, identify and bring to the attention of the staff study non-compliance
  • Perform ad hoc duties/projects as directed

Skills and Experience

  • Educated to degree level ideally within Biological Sciences or similar
  • Previous experience working within the Pharmaceutical/Clinical Research Organisation Industry is essential
  • Previous experience in the start-up of Clinical Trials is highly desirable
  • Excellent computer skills in key software e.g. Word, Excel, Powerpoint, email/outlook
  • Current awareness of appropriate EU Pharmaceutical legislation e.g. Clinical Trial Directives (2001/20/EC), ICH GCP

About the individual

The successful candidate will be able to work both independently as well as within a team. They will be able to communicate with staff on all levels. Excellent communication and organisational skills are a must.

#ichgcp #pharmajobs #oncology #cta #clinicalresearch #cancer #clinical

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