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Clinical Trials Administrative Support

Wilmington, DE

Posted: 01/09/2023 Job Number: 22801000

Job Description

CLINICAL TRIALS ADMINISTRATIVE SUPPORT
WILMINGTON, DE
100% Onsite.

Project Description:
  • Provides technical expertise and support for administrative aspects of clinical trials ensuring each study meets its objectives through adequate resources whilst adhering to methodology standards.
  • Liaises with a variety of departments both on a local and/or global level to ensure each study is set up correctly.
  • Provides solutions to a variety of issues relating to the conduct of a study of moderate scope and complexity.
  • Own and maintain quality for the study file as the local study team TMF owner.
  • Responsible for site communications and other portal management.
  • Running and analyzing reports from multiple systems.
  • Responsible for Vendor Management.
  • Handle requests for CTMS updates.
  • Operational responsibility to set-up the local Trial Master File (eTMF) including tracking of documents. Maintain and close the local TMF ensuring International Conference of Harmonization Guidelines for Good Clinical Practice (ICH/GCP) compliance and local requirements.
  • Support the CRA in the maintenance and close out activities for the ISF.
  • Contribute to the production and maintenance of study documents, ensuring template and version compliance

Required Skills:
  • Bachelor's degree is preferred.
  • 3-5 years of experience in clinical trials and regulatory documents is required.
  • Veeva experience a plus.
  • Accountable and inquisitive, thinks " outside the box ".
  • Must be methodical, compliant to processes yet flexible when needed.
  • High ability to manage priorities and Local Study Team expectations.
  • Independent yet able to work cohesively with a team.
  • Candidates must be local to Wilmington, DE, non-remote position.
  • Candidates MUST be able to work in the Wilmington office a minimum of 3 days per week.

This 12+month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: bridget@alphaconsulting.Com

ALPHA'S REQUIREMENT #23-00065
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

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Bridget Burns

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