Clinical Research Associate - Bethesda - job 1197378

Technical Resources International, Inc.

Date: 09/12/2021

City: Bethesda, Maryland

Employment type: Full-time


Responsibilities:



  • Provides site management and monitoring support for sponsored clinical studies; primarily Phase I and II, with limited Phase III and IV.

  • Performs on-site pre-study/qualification, initiation, routine, and close-out visits. Prepare site visit reports and provide assistance to site staff in resolving deficiencies.

  • Educates and trains site and study staff in management of sponsored studies, including assurance to regulatory and International Conference on Harmonization (ICH)/Good Clinical Practice (GCP) compliance.

  • Collects and processes regulatory documentation for investigational studies in compliance with required guidelines.

  • Assist in protocol, Informed Consent, and CRF design and review.

  • Develops and demonstrate understanding of and apply therapeutic area knowledge to assignments and project-related issues.

  • Appropriately resolves issues related to trial monitoring and management with guidance from Project Manager.

  • Decisions are made independently and with some supervision from Director, Clinical Operations/Project Management or Project Manager.

  • Tasks are primarily intellectual and require exercise of discretion and independent judgment.



Recommended Skills


Biopharmaceuticals

Medical Writing

Clinical Trials

Pre Clinical Development

Electronic Common Technical Document

Good Clinical Practices (Gcp)



Job Snapshot

Employee Type


Full-Time

Location


Bethesda, MD

Job Type


Biotech

Experience


Not Specified

Date Posted


08/19/2021

Job ID


416/136/683




How to apply:

To apply for this job you have to sign in to our website (My profile link in the header).

If you don't have an account with us yet, please Sign up.