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Clinical Research Associate II

2 months ago

Memphis, Tennessee, United States Allen Spolden Full time
Job Description

Allen Spolden is seeking a highly skilled Clinical Research Associate II to provide support for all clinical trials. As a key member of our clinical study team, you will work under the direction of a supervisor or designee to ensure the successful execution of clinical research functions.

Key Responsibilities
  • Participate in the design and preparation of protocols and case report forms, ensuring compliance with US and international guidelines.
  • Generate clinical SOPs, policies, charters, and plans, utilizing your knowledge of regulatory requirements.
  • Evaluate potential clinical sites, assessing their acceptability based on established criteria.
  • Procure budgets, contracts, regulatory documents, and other administrative documents necessary for clinical research functions.
  • Initiate studies, performing site visits, arranging for shipment of clinical supplies, and conducting ongoing study monitoring, including protocol adherence checks and material handling procedures.
  • Prepare site visit reports, highlighting key accomplishments, issues for resolution, and recommendations for follow-up actions.
  • 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 archives and electronic files.
Requirements
  • Bachelor's degree in a relevant field, such as life sciences, healthcare, or a related field.
  • Basic knowledge and adherence to Good Clinical Practices (GCPs).
  • 1-2 years of clinical research experience or equivalent experience or training.
  • Strong attention to detail, ability to multi-task, and high level of integrity and ethical standards.
  • Excellent written and verbal communication skills, with the ability to work independently and as part of a team.
Benefits
  • Dental, medical, vision, and 401(k) benefits.