Shervon Sturdivant

Wake Forest, NC *****

ad3kpb@r.postjobfree.com

+1-984-***-****

Work Experience

Senior Clinical Trial Associate

Liquidia Technologies - Morrisville, NC

July 2023 to January 2024

Executed, managed, and conducted studies associated with the company's clinical development plan. Assisted with project start-up, including development of budgets, contracts, financial disclosure statements, and grant payments

Assisted in the routing of Communication Logs and Protocol Deviations. Assisted in the preparation and distribution of project status reports. Provided support for maintaining both electronic and paper document-tracking systems for all documents associated with the start-up and execution of clinical studies Assisted in the oversight, processing and management of all clinical project-related documents including Investigator Site Regulatory Documents, Case Report Forms (CRF) and Monitoring Reports Reviewed and verify investigator site visit grant calculations, prepare PO requisitions, and forward invoices, site payment letters and expense reports Reviewed Investigator and Project files throughout a clinical trial and follow up with CSM on any discrepancy or missing documents

Assisted in the maintenance of Standard Operating Procedures (SOPs) and Work Instructions Assisted in the preparation of an Investigator Meeting Assisted with the maintenance of the Trial Master File (TMF) internally whether electronic or paper Senior Clinical Research Coordinator

Duke University - Durham, NC

December 2021 to June 2023

Assisted in the day-to-day support of study operations including tracking and creating overviews of subject, site, study status, milestones and performing quality check activities across components of the clinical study.

Assisted in study set-up including but not limited to eCRF design, protocol preparation, informed consents, investigator selection, systems (e.g., CTMS, IVR, etc.), manuals, training materials, and various study plans (e.g., visit logs, drug inventory, monitoring plan, etc.) Organized clinical trials, ensuring to meet all goals while retaining smooth operations. Processed and track clinical trial materials requests, study related supply requests, safety letters, vendor and investigator payments and other study-related activities as needed Assisted in the management of study completion activities including data review and clinical study report review

Ensure complete and timely collection and archiving of TMF documents of assigned studies or program, including oversight and/ or submission of regulatory documents tot eh TMF and ongoing document reconciliation.

Assisted in maintaining accurate and study information within CTMS and other relevant tracking systems Effectively communicated with study team members and work closely with Lead Study Senior Clinical Specialist

Worldwide Clinical Trials - Raleigh, NC

August 2018 to May 2021

Arranged and track system access for project team (Project Managers, Lead CRAs, CRAs, etc.)

Maintained and quality audit to assure the most recent revisions of documents are on project portals Assisted project team with preparation and shipment of clinical trial documentation, including Investigator Site File

Maintained version and quality control of project documentation and submit to trial master file Assisted with the tracking and maintenance of project related information, including site medical question and answer log

Generated and distribute minutes for a range of project related meetings, including Sponsor and Internal Management

Maintained current participating site and personnel information Arranged and track the distribution of project specific training to the project team Performed other duties as assigned

Clinical Coordinator

University of Pennsylvania - Philadelphia, PA

January 2015 to July 2018

Participated in the generation and implementation of study specific Monitoring Plan.

Assisted in the development of Case Report Forms.

Participated in identification and recruitment of investigators, collection of investigator documents and Site Qualification Visits.

Participated in Sponsor and Investigator/Initiation Meetings. Tracked progress of assigned studies and identifies appropriate actions to achieve target objectives. Fulfilment of on-site Monitoring responsibilities as documented in study-specific Monitoring Plan.

Process and track clinical trial materials requests, study related supply requests, safety letters, vendor and investigator payments and other study related activities as needed Organized clinical trials, ensuring to meet all goals while retaining smooth operations. PI Correspondence and maintaining project management. Site set up

Maintain a study matrix on global and country level. Prepared accurate and timely monitoring visit reports as established per the study-specific Monitoring Plan.

Identified and completed follow-up of SAEs at the study site. Case Manager II

McKesson Specialty Health / Amgen Safety Net

February 2012 to December 2017

Contacted payers to verify patient eligibility and product specific coverage information. Site set up

Maintained a study matrix on global and country level. Utilized internal resources to identify and provide alternate funding sources for patients without insurance or adequate coverage through their insurer

Interfaced with physicians, advocates, patients, and manufacturer representatives to obtain and provide drug specific coverage information, dependent on the specific program Provided prior authorization assistance as well as claims assistance, including billing and coding instructions, to physicians and/or office staff

Provided accurate and timely follow-up to all reimbursement inquires in accordance with program guidelines

Ensured that the intake information is accurate and complete to perform all reimbursement research Researched, obtained, and compiled payer specific information for reimbursement database (i.e., payer specific forms, coverage determination guidelines, etc.) Education

Bachelor in Biology

Hampton University

2007 to 2011

Skills

• 8 years of experience in Clinical Trials Management 10 years of experience working in a pharma industry 6 years of experience in materials management

• Clinical trials

• Research & development

• Research

• SharePoint

• Negotiation

• Analysis skills

• Project management

• Documentation review

• Clinical research

• Medical coding

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