Clinical Trial Specialist at U.S. Renal Care, Inc. in Plano, Texas

Job Description:

SUMMARY

The Clinical Trial Specialist is responsible for supporting the day-to-day implementation and operation of clinical study execution, monitoring activities, and other clinical trial support activities according to Standard Operating Procedures, International Council for Harmonization Good Clinical Practice (ICH-GCP) guidelines, and other applicable regulations.

The Clinical Trial Specialist is accountable for the execution of the study start-up strategy and planning and ongoing maintenance of a clinical trials, including the management and coordination of start-up activities such as alignment with country regulations, site document collection and approval, Informed Consent Form (ICF) customization, and trial master file (TMF) set-up and maintenance, as required per trial type.

Essential Duties and Responsibilities include the following. Other duties and tasks may be assigned.

• Collaborates and liaises with interdepartmental team members (regulatory, contacts, clinical) to enable a rapid clinical trial start-up.
• May provide a role in the coordination or collection of feasibility questionnaires for a study. Works with USRC Research Leadership to obtain approval of the study-specific feasibility questionnaire, as needed.
• May distribute Confidential Disclosure Agreements (CDAs) and feasibility questionnaires to sites and follows up with sites accordingly to assess interest and ability.
• Sends regulatory packets to selected sites and documents/follows-up with sites on the start-up process.
• Distributes and tracks protocol amendments and IRB/ethics approvals of the amendments, as required.
• Supports sites by providing answers to questions required for IRB/ethics committee submissions.
• Supports sites in the resolution of central IRB issues; assists with obtaining final review and approval.
• Supports the Director of Regulatory Affairs in liaising with central IRBs, as applicable.
• Provides central support to study sites to ensure their regulatory binder is maintained in compliance with GCP standards and sponsor regulations.
• Assists with the customization and review of site-specific Informed Consent Forms (ICFs); follows-up with sites as needed.
• Coordinates document translations required for IRB/ethics committee review/approval.
• Notifies the Director of Regulatory Affairs when initial essential documents are available for review. Works with the Director of Regulatory affairs to resolve any concerns.
• Contributes to the development of site-specific timelines for site initiation visits.
• Assists with set-up, routine maintenance, Quality Control (QC), and final completion of the electronic and/or paper TMF (as required per trial type).
• Maintains up to date and accurate tracking on the start-up status for each site in applicable system(s) for the study.
• Provides updates during routine internal and/or external team meetings.

• Actively promotes GUEST customer service standards; develops effective relationships at all levels of the organization.
• Participates in team concepts and promote a team effort; performs duties in accordance with company policies and procedures.
• Regular and reliable attendance is required for the job.