Freelance Clinical Expert in Ethics Submissions / RSU

Frankfurt am Main  ‐ Vor Ort
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Schlagworte

Beschreibung

We are searching a Clinical Expert in Ethics Submissions, Regulatory, Start-up (RSU) and Maintenance activities for our pharmaceutical client on a freelance basis:

Your future tasks:
  • Perform Ethics submissions, Regulatory Start-up and Maintenance activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members.
  • Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, RSU, Team Lead, Clinical Operations, Feasibility, Site Identification, Project Management and CST.
  • Prepare site regulatory documents, reviewing for completeness and accuracy.
  • Review, prepare and negotiate site contracts and budgets with sites.
  • Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
  • Review and provide feedback to management on site performance metrics.
  • Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.
  • Inform team members of completion of regulatory and contractual documents for individual sites.
  • Review, track and follow up the progress, the approval and execution of documents, including contracts, regulatory, ethics ICF and IP Release documents, in line with project timelines.
  • Provide local expertise to RSU leads and Project team during initial and on-going project timelines planning.
  • Perform quality control of documents provided by sites.
  • May perform Site Selection Visits if a trained monitor.
  • May participate in feasibility and/or site identification activities.


You should bring along the following skills:

* In-depth knowledge of clinical systems, procedures, and corporate standards
* Effective communication, organizational, planning and interpersonal skills
* Ability to work independently and to effectively prioritize tasks
* Ability to work on multiple projects
* Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
* Knowledge of applicable regulatory requirements, SOPs and company's Corporate Standards
* Understanding of regulated clinical trial environment and knowledge of drug development process
* Bachelor's Degree in life sciences or a related field and 1 year's clinical research or other relevant experience; or equivalent combination of education, training and experience.

Startdate: January 2015

Duration: 6 month with option for extension

Volume: 40 h / week
Location: office-based/ partly home based

Looking forward to receive you application!

Kind regards,

Stefan Blöchl
Start
01/2015
Von
Progressive Recruitment
Eingestellt
20.12.2014
Projekt-ID:
826158
Vertragsart
Freiberuflich
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