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Clinical Research Site Manager

2 months ago

Reston, Virginia, United States Eximia Research Full time
Job Summary

We are seeking a highly skilled Clinical Research Site Manager to join our team at Eximia Research Network. As a key member of our clinical research team, you will be responsible for the management of study teams and the overall coordination and successful execution of clinical trials.

Key Responsibilities
  • Manage project timelines, milestones, and critical study activities to ensure project deliverables are on time and within budget.
  • Assist with study start-up activities, including required training and vendor management.
  • Coordinate study activities to support milestone achievement and manage study issues and obstacles.
  • Conduct patient consents, follow-up visits, and obtain vital signs and ECGs/EKGs.
  • Document in source clinic charts, enter data in EDC, and answer queries.
  • Perform basic lab procedures, such as blood specimen collection and storing and shipping of lab specimens.
  • Request and track medical record requests, maintain and order study specific supplies.
  • Conduct monitoring visits and resolve issues as needed.
  • Ensure study related reports and patient results are reviewed by investigator in a timely manner.
  • Filing SAE/Deviation reports to Sponsor and IRB as needed.
  • Document and report adverse events.
  • Coordinate problem solving and resolution efforts to include management of risk, contingencies, and issues.
  • Troubleshoot and resolve clinic, protocol, and SOP issues and advise CRCs.
  • Participate in people management activities, including interviewing and selection, performance appraisals, and employee counseling.
  • Mentor and train personnel in study protocols, processes, and requirements.
  • Interpret regulatory guidelines to educate staff on operational activities for complex studies.
  • Facilitate project closure, including identifying lessons learned and incorporating them into future projects.
Requirements
  • Advanced therapeutic area knowledge.
  • Maintaining confidentiality of patients, customers, and company information.
  • Performing all other duties as requested or assigned.