Clinical Trial Specialist in | Careers at Advanced Clinical

Location
CH;Homeworking
Salary
Competitive
Posted
29 Mar 2021
Closes
13 Apr 2021
Ref
2021-13130
Discipline
Clinical Research
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Overview

This position is responsible for working with internal and external partners on all aspects involved with the planning, implementation and management of a clinical research trial(s). The CTS ensures that the most effective and efficient processes are in place to meet the timelines and deliverables commensurate with the planning, start-up, recruitment and close-out of the trial.

Responsibilities

  • Organize and maintain study files and regulatory documents and provide tracking support for trial-related activities including Trial Master Files (TMF)
  • Responsible for coordinating the day to day work flow of collection and review of required document for study start. The duties include set-up, maintenance and distribution of required documents.
  • Works with internal Clinical Trial Managers to coordinate activities (eg, documents, study supplies, distribution of system credentials etc.) leading to SIV.
  • Assists with conducting feasibility as applicable and/or support the documentation of decision related to final country/site selection.
  • Enter and maintain data into designated study tracking systems.
  • Assist the trial(s) team with communication/contact with investigative sites/external vendors
  • Assist in updating trial(s) status overviews, preparation of presentations, tracking of drug supply tracking
  • Help to ensure audit readiness of clinical trials across all compounds
  • Work closely with site to assist in center initiation and study start up activities
  • Documents site and sponsor communications as applicable
  • Supports investigators and investigative staff in fulfilling obligations with regard to local submissions according to local regulatory and Institution Review Board (IRB)/Independent Ethics Committee (IEC) requirements.
  • In conjunction with Study Manager, coordination and review of documents requiring translation (eg, diaries, emergency cards etc....)
  • Customize country/site specific ICFs /patient information sheets
  • Provides status updates to project and cross-functional teams as required
  • Collaborate and assist the development operations team and members of the multidisciplinary team on all operational aspects of the clinical study as assigned

Qualifications

  • BS/BA degree ore relevant degree
  • Strong organizational and time management skills
  • Excellent attention to detail
  • Ability to work independently
  • Willingness to complete routine administrative tasks while gaining exposure to regulations pertaining to clinical research
  • Experience with MS Office programs
  • Excellent written and verbal communication skills
  • Experience working as part of a multi-disciplinary team is desired
  • Research or healthcare-related experience is required

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