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Study Start Up Specialist

2021-09-07 10:23:582021-10-04 Pop Science
Job Type Permanent Full Time
Location United Kingdom
Area EMEA (other), Rest of World EMEA (other) Rest of World United Kingdom
Sector Science
Salary £30k - 35k per year
Currency gbp
Start Date ASAP
Advertiser remoteapi
Job Ref 1139
Job Views 59
Description

The Clinical Trial Coordinator will provide comprehensive support for the Drug Development Unit (DDU). They will manage the coordination and completion of essential trial documentation, with a focus on completing the trial-set up activities for the unit.

Shifts: 37.5hours/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.

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