Employment - Clinical Research Associate

Purpose of Job:

This position is responsible for supporting the activities of the clinical research group.

Major Duties and Primary Responsibilities:

  • Supports clinical team in tracking, organizing, filing and maintaining all study-related documents in accordance with applicable regulations (i.e., ISO 14155, Federal Regulations, GCP).
  • Assists clinical team members in handling data queries, study invoice and payment, enrollment tracking, record reconciliation with site documentation.
  • Sets up and manages process to track and report critical study information such as enrollment, IRB/EC approval status, appropriate training of site personnel, device usage and payment information as needed.
  • Ensures proper product supply, accountability, and storage during assigned clinical studies by processing orders, maintaining inventory information, and maintaining device accountability tracking information.
  • Works with the Clinical Trial Managers to ensure that sites receive the study documentation necessary to secure IRB/EC approval and ensures that sites have the study materials needed for the conduct of the study (e.g., regulatory binder, CRFs, etc.).
  • Works with the Clinical Trial Managers to ensure timely collection of study documentation for clinical sites.
  • Processes case report forms for data entry and/or for timely review and proper handling of adverse event reports in accordance with company procedures and regulatory requirements.
  • Reconciles data queries and data clarifications with sites.
  • Assists the Safety Coordinator/Monitor with collection and compilation of materials for the Clinical Events Committee and the Data Safety and Monitoring Board.
  • Assists in various projects, as assigned.

Job Requirements:

Bachelor's Degree (or equivalent combination of education and work experience) required, and a minimum of 3 years industry experience, including at least 1 year as a CRA. Knowledge of and competence in application of CFRs, GCPs, ISO, and ICH Guidelines. Demonstrated proficiency in required software and computer skills. Ability to independently set and manage multiple priorities. Ability to apply, or assist others in applying, the appropriate level of detail to achieve project goals in a timely manner with attention to applicable regulations. Operates effectively as a team member or leader with an understanding of team dynamics; demonstrates ability to guide others in effectively executing work processes. Excellent oral and written communication skills.

Interested candidates should submit their resumes via email.