Job Details

Job Description:

Pay Range: $70000Years - $85000Years

Responsibilities:

• 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 follow 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.
• ssists 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.
• ssists 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 the applicable system(s) for the study.
• Provides updates during routine internal and/or external team meetings.
• ctively promotes GUEST customer service standards; develops effective relationships at all levels of the organization.
• Participates in team concepts and promotes a team effort; performs duties in accordance with company policies and procedures.
• Regular and reliable attendance is required for the job.

• Bachelor's degree in related field required.
• Eighteen (18) plus months of relevant experience required.
• Demonstrated proficiency in project management including planning, execution, delivery, and reporting.
• Demonstration of proactive problem-solving skills.
• Good knowledge of clinical research processes related to study start-up and medical terminology.
• n understanding of regulatory and central/local IRB submission processes.
• bility to manage multiple competing priorities.
• Working knowledge of current ICH GCP guidelines and applicable regulations.
• dvanced analytical skills required.
• Valid driver's license in applicable state.
• License must be maintained as current, without restrictions and good driving record.
• Proficient computer skills, including Microsoft Office (Word and Outlook); proficiency in required USRC applications within 90 days of hire.

• Minimal travel/overnight travel may be required (up to 30% of time).
• Noise level in the typical work environment is moderate due to the number of staff in the business office area and staff/patients/equipment in patient care areas.