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Job Details


PRA Health Sciences

Clinical Research Associate II (Home-Base)

Pharmaceuticals

All

Yearly

No

Gaithersburg, Maryland, United States

ESSENTIAL FUNCTIONS:

  1. Assists Clinical Project Managers in project coordination, planning and logistics, including overview of budgets and timelines as needed.
  2. Participates in project team meetings.
  3. Assists the Project Managers with the follow up and resolution of action items, risk mitigation and Corrective and Preventative Action plans.
  4. Works with the Project Managers to select qualified and experienced research sites. This includes feasibility questionnaire generation, site outreach, tracking of feedback and overall review of site responses/qualifications.
  5. Provides training to CRAs (Basic orientation, CTMS, Protocol Specific).
  6. Provides daily oversight of CRAs including co-monitoring for assessment and evaluation.
  7. Develops clinical monitoring plans and assist in development of associated study documents (Safety Monitoring Plans, Manual of Operations and Informed Consents).
  8. Assists CRAs and QA specialist in identification of site issues/problems, and associated root causes, and development action plans to ensure resolution, including escalation of appropriate issues in a timely manner.
  9. Acts as the main line of communication between the sponsor and the CRA.
  10. Reviews and approves monitoring reports and follow up letters.
  11. Provides management of study sites to ensure site compliance with study protocols, GGP/ICH, and applicable regulations.
  12. Conducts monitoring visits as needed (Qualification, Site Initiation, Interim, Close-out, Audit Prep.)
  13. Verifies that all research staff and facilities have adequate qualifications and resources and are maintained throughout the course of the clinical study.
  14. Verifies that the investigator and research staff follow the approved protocol and all GCP procedures.
  15. Ensures adverse events, concomitant medications, and inter-current illnesses are reported in accordance with the protocol on the CRF.
  16. Communicates deviations from the protocol, SOPs, GCP, and applicable regulatory requirements to the investigator and ensure corrective action is implemented.
  17. Reviews queries and assist in resolution.
  18. Utilizes CTMS to generate, review and provide study reports.
  19. Assists with setup, quality and maintenance of the Trial Master Files (TMF) in accordance to Clinical RM SOPs, Good Clinical Practice (GCP), ICH guidelines and federal regulations.
  20. Assists with the selection, communication and maintenance of project related vendors.
  21. Performs ongoing reviews of the TMF to ensure quality of the documentation files and compliance with Clinical RM SOPs, GCP and ICH guidelines.
  22. Assists the Project Management team in preparation for audits or inspections.
  23. Works with the Project Managers to ensure all the required study documentation (agreements, site SOPs, etc.) have been obtained from the site prior to site initiation.
  24. Participates in the department review of SOPs when needed.
  25. Assists with protocol development and review as needed.
  26. Provides technical assistance for proposal writing as needed.
  27. Reviews Safety and Clinical Study Reports.

ICON Government and Public Health Solutions is a full-service CRO specializing in preclinical through phase IV support of clinical research and clinical trial services for biologics, drugs, and devices. We help our customers get their products to market faster with an array of research, regulatory, and sponsor services. Globally, we respond rapidly to health crises and serve where few others do. We create a unique synergy in the global market, with projects spanning the government, academic, and commercial sectors. ICON Government and Public Health Solutions has a distinct ability to provide rapid response efforts to global health crises.