Clinical Research Associate II

3 weeks ago


Charlotte Court House, Virginia, United States Allen Spolden Full time
Job Title: Clinical Research Associate II

Allen Spolden is seeking a highly motivated and detail-oriented Clinical Research Associate II to join our team.

Job Summary:

The Clinical Research Associate II will provide clinical research support for all clinical trials, working under the direction of a supervisor or designee. This role will serve as a key member of the clinical study team, responsible for ensuring the successful execution of clinical trials.

Key Responsibilities:
  • Participate in the design and preparation of protocols and case report forms.
  • Generate clinical SOPs, policies, charters, and plans according to US and international guidelines.
  • Participate in the evaluation of potential clinical sites according to established criteria of acceptability.
  • Procure budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions.
  • Initiate studies, perform initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary ongoing study monitoring functions.
  • Prepare site visit reports with identification of key accomplishments, key issues for resolution, and recommendations for follow-up actions for assigned study sites.
  • Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission.
  • Assist with the maintenance of clinical archive and electronic files.
Requirements:
  • Bachelor's degree in a related field or equivalent experience.
  • Basic knowledge and adherence to GCPs.
  • 1-2 years of clinical research experience or equivalent experience or training.
  • Strong attention to detail.
  • Ability to multi-task.
  • Unquestionable integrity and highest ethical standards.
  • Excellent written and verbal communication skills.
  • Self-motivated, assertive, and driven.
Benefits:
  • Dental, Medical, Vision, and 401K.


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