Susan Creasy

About Susan Creasy

Experienced Clinical Research Associate with a demonstrated history of working in the hospital & health care industry. Skilled in Clinical Site Monitoring, Clinical Trial Management System (CTMS), Microsoft Office, Protocol, and Good Clinical Practice (GCP). Strong research professional with a Bachelor\'s degree focused in Biology from University of North Carolina at Chapel Hill.

Experience

1. Clinical Operations Lead

   PharPoint Research, Inc.

   Jul 2023 — Present

   Acting COL July 2022-July 2023•Train, manage, and assess CRAs in the conduct of clinical trials, including site management & monitoring responsibilities.•Develop and update the Clinical Monitoring Plan and assist with the writing of additional project plans. •Review and approve site visit reports. Ensure CRA site visit scheduling requests, site visit reports, and follow-up correspondence are timely and in accordance with SOPs.•Perform CRA assessment visits as directed by PharPoint Management and complete assessment reports per SOP.Provide field and/or in-house training as part of career development for CRAs, assist in training progress assessment, and facilitate career development training for direct report employees.•May conduct pre-study site visits, review the accuracy of study initiation documents as well as coordinate study drug supply, laboratory supplies, and oversee study reference manual development. •Arrange and perform periodic quality control visits to research sites according to clinical monitoring plans.•Assist PM with the management and evaluation of contracted services (central lab, IVRS, IRB). •Work with the PM to understand the fiscal performance of the study through negotiation of investigator budgets and monitor investigator payments. •Assist in the identification and recruitment of potential investigators; verify site qualifications. •Review and approve all essential regulatory documents required for implementation, monitoring, and evaluation of clinical trials, as well as design protocol-specific manuals, plans, and documents. •Work with project team members to prepare study forms and provide status reports on enrollment and CRF submission. •Review all site and sponsor communications.•Assist with biannual quality TMF reviews.•Conduct a close-out inventory of clinical supplies and coordinate the return of unused materials.•Work in conjunction with the PM to coordinate clinical study organization, implementation, and management.

Education

• The University of North Carolina at Chapel Hill

  Bachelor's degree, Biology

  2007 — 2011