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980-***-****

Summary

•13+ years of Clinical Research (CRO) experience

•10 years of Oncology experience

•5 years of Clinical Lead experience

•10 years of monitoring experience

•15 years of site management experience

•5 years of CRA line management experience

•Experience developing Clinical Management Plans, Site Management Plans and Corrective Action Plans

•5 years of CAPA experience

•15 years of patient recruitment experience

•15 years of inspection readiness experience

•5 years of project planning and project resourcing experience

•2 years of experience managing budgets

•5 years of global experience (China, Canada, Italy, France and US)

•Experience participating on 5 bid defense meetings

•Proficient in EDC and MS Project

Professional Experience

06/2021 – Present SENIOR CLINICAL TRIAL MANAGER

Precision for Medicine

•Responsible for the management and operational delivery of the clinical

elements within a trial including site selection, start-up, enrollment management, site engagement and support, monitoring planning and execution, data cleaning activities and close-out

•Responsible for the independent clinical project delivery to timeline and budget and in accordance with Good Clinical Practice (GCP), ICH Guidelines and Health Authority Regulations

•Responsible for the management and operational delivery of the clinical elements within a trial including site selection, start-up, enrollment management, site engagement and support, monitoring planning and execution, data cleaning activities and close-out

•Responsible for the successful execution of clinical elements of the assigned trials and in ensuring the completion of clinical trial deliverables.

•Collaboration with other functional team members to ensure appropriate communication, regulatory documentation, and ongoing oversight of assigned clinical trial(s)

•Provided training and mentoring of clinical team members

02/2019 – 06/2021 CLINICAL TRIAL MANAGER

IQVIA

•Responsible for assuring needs of clinical sites are met by facilitating clinical monitoring processes

•Coordinated site management activities:

oSite identification, recruitment, and selection o Regulatory document collection and review o Overall scheduling and management of all site visits o Develop site/monitoring tools and training materials

oReview and identify trends in enrollment and data entry at sites and proactively interface with clinical monitoring team and client to identify solutions

•Coordinated and overseer of daily operations of the clinical monitoring team:

oSet and enforce project timelines with the assigned study team o Coordinate remote review of clinical data within EDC system

oOversee monitoring visit schedule to ensure compliance with frequency set forth in contract

oReview and approve trip reports and follow-up letters within required timeframe

oSchedule and manage weekly CRA project team meetings o Ensure CRAs assigned to team receive therapeutic and project- specific training

oManage quality and regulatory compliance among clinical monitoring team and investigational sites

•Managed project milestones and proactively address deficiencies:

oAttend and provide information at monthly projections meetings o Attend and provide information at weekly clientele conferences/team meetings

oAssist Project Manager in identifying Out of Scope activities and assuring that such activities do not begin until the client provides authorization

•Managed CRA performance:

oDefine and implement functional standards, goals, and expectations with clinical monitoring team

oServed as CRA mentor and perform accompanied field assessment visits as required

oParticipated in the performance appraisal program by providing timely and accurate feedback regarding the performance of CRAs

•Documented Duties/Responsibilities:

oAssured that the appropriate company and sponsor SOPs are followed

oEnsured all project documentation was appropriately filed per company

SOPs o Assist PM in preparation of audit responses, as appropriate o Assist PM with preparation of information for inclusion in monthly report to client

•Budget/Contract Duties/Responsibilities:

oAssist PM in review of project budgets, monitoring costs, potential overruns and propose/implement cost effective solutions

oDefine the scope of work with the client and clinical monitoring team

oAssist PM in identifying and generating changes in scope and notify client of potential changes in scope o Review and approve CRA travel expenses and time sheets

2018 – 2018 CLINICAL TRIAL MANAGER

George Clinical

•Responsible for overseeing and coordinating all study management activities, study teams, and project timelines

•Managed CRA team for projects

•Aided in the development of project plans

•Negotiated site contracts/budgets

•Co-monitored as needed

2012 – 2018 SENIOR CLINICAL SITE MANAGER / SENIOR CLINICAL MONITORING ASSOCIATE/ CLINICAL SITE MANAGER

PAREXEL International

•Provided leadership for clinical research studies, ensuring timelines and deliverables were met and exceeded standards

•Performed accountability, quality and delivery management from start-up phase to site closure

•Managed country specific feasibility, and site pre-qualification and qualification activities- configured, distributed, collected, reviewed, and approved country and site-specific documents and essential regulatory documents (SRP)

•Prepared and submitted IRB/IEC applications in accordance with country/regulatory/client requirements

•Assisted project management team with monitoring plan- forecasted, developed management plans and strategies for site activation, patient recruitment & retention through site closure

•Performed protocol amendments support throughout the life of the study

•Assisted in Investigator and other external or internal meetings, audits & regulatory inspections

•Managed multiple priorities to achieve project timelines

•Supported CRAs in successfully monitoring clinical trials by reviewing site

reports, resolving site issues and maintaining training records

•Provided leadership for clinical research studies, ensuring timelines and deliverables were met and exceeded standards

•Performed issue resolution, patient enrollment management, handling protocol- and/or ICF- and/or contract amendments

•Performed remote and onsite clinical monitoring visits for designated projects

•Supported CRAs in successfully monitoring clinical trials by reviewing site reports, resolving site issues and maintaining training records

•Performed drug and supply management and ensured timely data entry at a site level

•Performed and conducted study start up activities from qualification, initiation, and termination of investigational sites

•Managed site regulatory document collection and review for site initiation

•Managed financials for each study including: budget negotiations, forecasting, invoice reconciliation

2007 – 2012 SENIOR CLINICAL RESEARCH ASSOCIATE/ LEAD CRA

CLINICAL RESEARCH ASSOCIATE II

CLINICAL RESEARCH ASSOCIATE

ICON Clinical Research

•Performed pre-study, initiation, site monitoring and close-out visits

•Managed clinical research sites according to SOP’s, ICH & GCP Guidelines

•Recruited investigators for several protocols

•Managed database trackers for subject recruitment and subject compliance

•Managed trackers for query resolution and error reductions

•Maintained study payments for sites and authorized payments

•Mentored new employees and assistants on developmental goals and timelines

•Completed Serious Adverse Event reporting to Local and Central IRBs

•Extensive training in GCP, FDA and ICH guidelines

•Manage small projects under direction of a Project Manager/Director

•Serve as Lead Monitor for numerous protocols

•Participated in reviewing clinical trial reports

2004 – 2007 FORENSIC DNA ANALYST/ SUPERVISOR

Orchid Cellmark

•Supervised small team of DNA Analyst assisting in criminal DNA cases

•Served as lead supervisor of protocol and standard operational procedure guidelines

•Team lead on projects for vamping production goals to meet targeted objectives

•Organized and made presentations for annual DNA workshops and meetings

•Responsible for laboratory supplies and the maintenance of laboratory equipment

•Responsible managing client relations and recruiting business wins

•Responsible for performing DNA profiling on biological samples as well as interpret test results for criminal casework, convicted offender database samples, paternity biological relationship cases, and/or private DNA testing contracts

Education

Tennessee State University/Vanderbilt University, Nashville, Tennessee

Masters of Art and Sciences, Biology with an emphasis in Neuropharmacology

University of Southern Mississippi, Hattiesburg, Mississippi

Bachelor of Science, Psychology; Minor concentration in Biology and Major concentration in

Neuroscience, emphasis in Neuropharmacology

Project/Therapeutic Experience

Oncology

•Phase I, Multiple Myeloma

•Phase I, Melanoma

•Phase I, Solid and Pancreatic Tumors

•Phase I, Malignant Tumor of the Kidney

•Phase I, Squamous Cell Carcinoma

•Phase II, Malignant Tumor of the Ovary

•Phase III, Breast

Neurology

•Phase II, Epilepsy

•Phase III, Meningitis

Respiratory

•Phase III, COPD

Endocrinology

•Phase III, Diabetes Mellitus

CNS

•Phase IV, Fibromyalgia

•Phase IV, Pain Management

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