CLINICAL TRIALS ADMINISTRATIVE SUPPORT WILMINGTON, DE 100% Onsite.
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
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