Clinical Research, Data Auditing, Phone/Written/Verbal/Person Skills+

MATTHEW D. GEIDEL, BA, CCRP

***** ******* ***** **.

Cypress TX 77433

Mobile: 281-***-****

********@*****.***

EDUCATION

Bachelor of Arts - Psychology University of Houston: Houston, Texas Graduated: December 2006

CERTIFICATIONS

CerƟfied Clinical Research Professional (CCRP)

RELATED PROFESSIONAL EXPERIENCE

SR CRA I

Kapadi – SR CRA I – Regionally Based Texas:

• Assigned CRA for Phase I trial iniƟaƟon, setup, and conduct for solid tumor research.

• Completed assignment of 3 data database locks on 3 trial cohorts for phase 1 AML trials.

• Acted as the main point of contact, coordinaƟng with other roles and funcƟons of site-level acƟviƟes.

• Lead site recruitment planning and effecƟve implementaƟon of plans.

• Focused on inspecƟon readiness and provides support for audits/inspecƟons.

• Responsible for site and monitoring quality, regulatory and Good Clinical PracƟce

(GCP) compliance.

• Supported country/site specific ICD review, revision, and submission.

• Accountable for site start up procedures including the feasibility and recruitment of potenƟal invesƟgators, preparaƟon of EC/IRB submissions.

• Ensured the strategy for InvesƟgaƟon Product (IP) and ancillary supplies.

• Ensured successful site-level recruitment and operaƟons and ensures the quality and paƟent safety at the invesƟgator site.

• Collaborated with the site coordinators and principal invesƟgator.

• Evaluated site processes and recommends restructuring for improvement. Site Care Partner

Parexel - Embedded – Regionally Based Texas: Pfizer FSP

• Responsible for novel relaƟonship building and operaƟonal oversight of site.

• Acts as the main point of contact, coordinaƟng with other roles and funcƟons to align with target sites, simplifying site and Client communicaƟons and enhancing the confidence in quality of site-level acƟviƟes.

• Lead site recruitment planning and effecƟve implementaƟon of plans.

• Provided site recommendaƟons uƟlizing a broad understanding of the sites.

• Accountable for uƟlizing tools and data driven reports to proacƟvely detect quality and compliance risks at novel invesƟgaƟve sites.

• Focused on inspecƟon readiness and provides support for site audits.

• Responsible for site and monitoring quality, regulatory and GCP compliance.

• Supported country/site specific ICD review, revision, and iniƟal submission.

• Accountable for site start up procedures across mulƟple facets.

• Ensured the strategy for InvesƟgaƟon Product (IP) and ancillary supplies for sites.

• Responsible for ensuring that sites receive essenƟal support resolving issues and maintaining the client's reputaƟon throughout selecƟon and start-up.

• Ensured successful site-level recruitment was feasible.

• Offered insight for site recommendaƟons through understanding of the sites.

• Managed the iniƟaƟon of sites selecƟon acƟvaƟon and essenƟal documents.

• Served as the main operaƟonal contact for any site-level inquiries.

• Collaborated with the site monitor to fostering construcƟve relaƟonships.

• Evaluated site processes and recommended restructuring as needed. Senior Clinical Research Associate III:

IQVIA - Embeded – Regionally Based Texas: Boston ScienƟfic

• Multiple Phase 3 Unblinded monitor for trials 30-80 paƟents.

• Phase 3 Unblinded monitor for device trials. 0 PaƟents. Study in close out.

• Performed site monitoring visits (selecƟon, iniƟaƟon, monitoring and COV).

• Worked with sites to adapt, drive, and track subject recruitment plans.

• Administer protocol and related study training per site staff roles.

• Evaluate the quality and integrity of sites to ensure paƟent safety and data validity.

• Manage the progress of assigned studies tracking of essenƟal documents.

• Ensure copies/originals of documents are secured for TMF filing/submission.

• Acted as a mentor for clinical staff including conducƟng co-monitoring and training.

• Collaborated and liaise with study team members for project conduct support.

• If applicable, accountable for site financial support to internal staff and site. Senior Clinical Research Associate II/ Clinical Research Associate I/II/III: PRA Health Sciences/ICON – Regionally Based: NovarƟs FSP

• Resourced in oncology, akonylising spondiliƟs, osteoarthriƟs, and mulƟple sclerosis. Experience with genitourinary, bladder, breast, lymphoma, melanoma, leukemia, nasopharyngeal, NSCLC, and head and neck cancers.

• Supported management in training of novel CRA’s

• Implemented and monitored clinical trials to ensure proper oversight

• Assessed the qualificaƟon of potenƟal invesƟgaƟve sites, iniƟated clinical trials at invesƟgaƟve sites, trained site personnel, and closed clinical trials as needed.

• Reviewed and verified accuracy of clinical trial data collected, onsite or remotely.

• Assisted in updaƟng SOPs and training of new systems, guidance.

• Completed monitoring acƟvity documents as required by SOPs/guidance/GCP.

• Assisted in selecƟon, recommendaƟon, and onboarding of novel invesƟgators.

• Provided guidance to sites and parƟcipated in sponsor or FDA audits

• Escalated site and trial related issues per SOPs.

• Performed expert essenƟal document site file reconciliaƟon

• Performed source document verificaƟon and query resoluƟon

• Assessed masked and unmasked IP accountability.

• Verified Serious Adverse Event (SAE) reporƟng according SOPs/GCP.

• Updated applicable tracking systems

Department of Immunology – Sr. Coordinator, Clinical Studies: M.D. Anderson Cancer Center – Houston, Texas

Conducted ongoing training and guidance of Immunotherapy Plaƞorm (IMT) personnel.

Ensured Ɵmely, comprehensive, and accurate protocol document submission.

Coordinated educaƟonal acƟviƟes for the research staff, as requested by supervisor.

Collaborated with the wriƟng of research policies/processes/QA.

ParƟcipated in the planning and implementaƟon of cross-departmental acƟviƟes.

Ensured that clinical research conducted met IRB/federalinsƟtuƟonal guidelines.

Developed systems, policies, and procedures for submission, review, approval and tracking of protocols plus contract negoƟaƟon and execuƟon, according to insƟtuƟonal and external requirements.

Managed large-scale and mulƟple site and mulƟ-departmental research acƟviƟes.

Conducted analyses of processes and idenƟfied and resolved as needed.

Tracked progress of insƟtuƟonal trials associated with the IMT Plaƞorm.

Ensured appropriate training for parƟcipaƟng departments.

AƩended relevant departmental and set-up/coordinaƟon of study start-up meeƟngs.

Prepared quality reports and metrics for monthly meeƟngs.

Maintained working knowledge of current CFR/GCP.

Demonstrated excellent oral and wriƩen communicaƟon skills.

Collaborated with industry sponsors and supporters, as necessary

Created, updated, and maintained current regulatory files for IMT led protocols.

Collaborated with mulƟple departments and/or outside insƟtuƟons.

Ensured Ɵmely response to sponsor queries across parƟcipaƟng departments.

Assisted with preparaƟon for audits and monitoring visits.

Assisted with protocol budget creaƟon, payments and agreements.

Performed account reconciliaƟon.

Performed monthly invoicing according to contracts. Office of Protocol Research – Human Research RegulaƟons Specialist: M.D. Anderson Cancer Center – Houston, Texas

Analyzed research applicaƟons and submissions for regulatory compliance.,

Acted as a consultant and mentor for insƟtuƟonal clinical research faculty and staff.

Ensured proper submission to the appropriate regulatory agency.

Developed, prepared, and maintained documentaƟon of research applicaƟons.

ParƟcipated in insƟtuƟonal development of novel systems with outside developers.

Assisted in user-end design and data workflow from old system applicaƟons to new.

Obtained, cleaned, and maintained data.

Created reports for use in reviewing specific applicaƟon informaƟon and general trends.

Conducted professional phone and face-to-face interacƟon with insƟtuƟonal physicians, insƟtuƟonal staff, federal bodies, and others.

Conducted quality assurance.

Developed recommendaƟons on workflow operaƟons and processes.

Assisted in creaƟng, updaƟng, and maintaining current departmental/divisional SOPs.

Designed and provided training sessions for faculty and staff on insƟtuƟonal level.

DraŌed official insƟtuƟonal communicaƟons for regulatory purposes.

Acted as consultant and mentor per GCP.

ParƟcipated in training of new IRB faculty in addiƟon to duƟes of training new staff. Genitourinary Medical Oncology – Coordinator, Clinical Studies: M.D. Anderson Cancer Center – Houston, Texas

Responsible for assembling regulatory submissions per GCP/CFR.

Timely submission of required regulatory documents.

Spearheaded, developed, and maintained independent regulatory policies.

Developed and maintained electronic regulatory database via a SharePoint site.

Created, updated, and maintained departmental/divisional ISF files per GCP/SOP

Ensured appropriate filing of regulatory documents for all protocols.

ParƟcipated in rouƟne protocol monitoring and query response.

Assisted in FDA audits for site verificaƟon.

DistribuƟon of SAEs per GCP guidelines.

Assisted in development and maintenance of regulatory document control systems.

ParƟcipated in orientaƟon/training of new employees Genitourinary Medical Oncology – Coordinator, Research Data: M.D. Anderson Cancer Center – Houston, Texas

Responsible for accurate and Ɵmely entry of study data to EDC.

Generated in-depth reports and spreadsheets from mulƟple databases.

Assisted with quality assurance of data as transcribed to mulƟple databases.

Provided user-end feedback concerning data migraƟon to novel databases.

Consulted with mulƟple invesƟgators and research nurses.

Assisted with departmental regulatory tasks/monitoring visits. Behavioral Science - Research Assistant:

M.D. Anderson Cancer Center – Houston, Texas

Contacted and scheduled paƟents to parƟcipate in study interviews.

Responsible for data entry of paƟent informaƟon.

Coordinated with study monitors.

Applied Behavior Analysis - ABA Senior Therapist:

Overcoming AuƟsm Through Hope – Houston, Texas

Houston Behavioral IntervenƟons Inc – Houston, Texas Kids E.T.C. Early Treatment Center – Bellaire, Texas Texas Young AuƟsm Project: T.Y.A.P. – Houston, Texas

Evaluated, designed, and implemented effecƟve Behavioral IntervenƟons and Behavioral Analysis.

Educated parents concerning auƟsm treatments and intervenƟon methods.

Collected and organized data acquired during clients therapy sessions.

Coordinated supervision and training among Level I & II therapists, senior therapist, Case Supervisor, and clients for proper treatment implementaƟon and maintenance. SKILLS AND TRAINING

Outstanding professional wriƩen and oral communicaƟon skills.

Very Proficient in mulƟple CTMS, CIOMS, RAVE, EMR, Box, Docusign, ADOBE, Concur Regulatory Systems.

Extensive experience in criƟcally reviewing essenƟal documents

Skilled in leadership roles and coordinaƟon among self, supervisors, and co-workers.

Proficient in construcƟon, development, and maintenance of Regulatory Files.

Extensive communicaƟon skills between insƟtuƟonal, FDA, NCI, DOD, sponsors, supporters, and other Federal/Private insƟtuƟons required.

Skilled in FDA audit methods and techniques.

Excellent working relaƟonship with peers

Extensive work with mulƟple sponsors systems to ensure accuracy of data as well as maintenance of required regulatory documentaƟon.

Experience in the training and development of new employees.

Extensive experience in the use of MicrosoŌ Office, Windows.

Experience in designing, implemenƟng, and evaluaƟng Experimental Analyses.

Human Subjects ProtecƟon Training – April 2008 - Present

NaƟonal InsƟtute of Health – ProtecƟng Human Research ParƟcipants.

Contact this candidate