Clinical Research Associate

Education

- Bachelor of Science, Biology Pre-Medicine, Liberty University, May 2012

- Certified Phlebotomy Technician, April 2019

- Google Database Analyst Certification, December 2022

Career Experience

Clinical Programmer and Clinical Research Associate – Health Policy Associates Jul 2024 – current

Managing and monitoring clinical studies for investigational drugs, biologics, and medical devices

Training study site personnel according to protocols and good clinical practice

Operating and building electronic data capture (iMedNet) with CAD

Administrating access and troubleshooting EDC personnel and projects

Database design and development

Providing study site support to ensure protocol compliance and complete data collection

Resolve administrative issues on behalf of project managers

Facilitates interoffice communication and task triage

Assisting study sites with IRB approval and submission procedures

Developing trial-related documents including developing case report forms, organizing patient binders, and tracking regulatory documents

Maintaining project trackers for contemporaneousness and completeness

Updates investigative site file reconciliation and uploads into the electronic Trial Master File, Montrium

Creation of department workflows

Tracks and coordinates site study and procedure supplies

Performing data edit checks and data queries to flag increased areas of risk or non-compliance

Managed Gantt project tracking system for client reporting

Senior Clinical Trial Navigator – Javara Nov 2023 – June 2024

●Screened, enrolled, processed, and completed follow up with research participants

●Completed GCP, CITI, IATA and study specific trainings

●Trained new team members, directed study team operations

●Utilized Medidata RAVE, Zelta, and Clinical Conductor EDC for eCRF documentation

●Worked from TouchWorks EMR for chart review, candidate screening, and testing

●Recorded and reported AE, SAE, and PD in timely fashion and accordance with regulations

●Kept up to date regulatory binders through Florence, and filed regular continuing reviews

●Coordinated with industry sponsors and facilitated site initiation and monitoring visits

●Developed SOPs for office operations and study specific practices

●Performed spirometry, oscillometer, and FeNO breath testing

●Administered health rating scales, AIRQ, EQ-5D-5L, CSSRS

Applications Database Analyst – BI Incorporated July 2022-July 2023

Provided company specific product response

Created, obtained, and delivered reports to upper management

Performed inventory scrapping

Validated updates on proprietary mobile applications and websites

Troubleshoot

Provided data for analytics on products, customers, and clients

Managed SQL server database through

Elastic Kibana

Utilized Microsoft SQL, Inform, and Excel to respond to service desk requests and client support requests

Provided scheduled company wide inventory scrapping including analytics documentation and SRO closure

CR Data Coordinator – Medix Contracting with QuantumLeap Health June 2021-July 2022

●COVID-19 first line drug treatment for severe, hospitalized COVID patients

●Entered data from EMR, PowerChart, into EDC, Open Clinica

●Engaged with site team regularly

●Resolved data queries accurately and expediently

●Collaborated with sponsor and sites across the nation

●Created and maintain patient enrollment tracking spreadsheets

●Assisted with designing SOPs and study wide instructional documentation

Data Coordinator – Syneos Contracting with GSK Pharmaceuticals December 2020-May 2021

●COVID-19 Monoclonal Antibody treatment

●Entered data from eCRF into EDC, InForm

●Assisted sites with data conversion from paper forms to electronic documentation

●Collaborated with sponsor and sites across the nation

●Evaluated and analyzed source documentation from uploaded documents in Protocol First for eCRF completion

●Resolved data queries accurately and expediently

●Adhered to Good Clinical Practice and all GSK policies

●Supported data entry activities to meet study data needs and deadlines

●Obtained source documentation for patients enrolled into clinical trials and data registry

●Maintained Data Registry

●Assisted with Data validation, conflict resolution and quality assurance

●Supported Clinical Project Manager to meet industry trial data deadlines

●Assisted Clinical Project Manager with query resolution

●Created and maintain patient visit tracking spreadsheets for Clinical Project Manager

●Maintained and archive study administrative file

●Met with clinical study sponsor representatives as requested

●Initiated improvements, tools, processes, and forms to enhance the efficiency and quality of work, spearheading new snapClinical Manager

●Attended meetings as assigned and report on actions

●Spearheaded post data collection reconciliation of patient paper forms into newly designed company collection system, snapClinicalManager

REDCap Support Specialist – Denver Health February 2021-April 2021

●Provided expert support on organization wide EDC

●Building complex REDCap database projects, REDCap administrator

●Provided data management and data tracking

●Clinical data collection and analysis

●Managed incoming REDCap administrative requests (project changes, project builds, data analysis, system developments and operational projects)

●Performed monthly update assessment

●Updated all training materials and SOP for Denver Health

Clinical Research Coordinator and Lab Manager – Denver Neuro Research January 2020-April 2020

Neurology – Migraine, Alzheimer’s, Parkinson’s disease, Dementia

●Initiated study protocol Western IRB submissions and amendments

●Screened, enrolled, processed, and completed follow up with research participants

●Completed GCP, CITI, IATA and study specific trainings

●Coordinated interdisciplinary study projects

●Utilized Medidata RAVE EDC for eCRF documentation

●Worked from Practice Fusion and EMR for chart review, candidate screening, and patient correspondence

●Recorded and reported AE, SAE, and PD in timely fashion and accordance with regulations

●Kept up to date regulatory binders, and filed regular continuing reviews

●Coordinated with industry sponsors and facilitated site initiation and monitoring visits

●Developed SOPs for office study practices

●Prepared budgets and study feasibility analysis for new trials

●Managed office database for all patients and procedures

●Organized and performed postoperative outcomes questionnaires and data collection

●Developed data collection, management, analysis, and supply storage plans

●Assisted with conflict of interest analysis and management plan development

●Received, stored, and dispensed research inventory including chain of custody records

●Collected ECG, blood draws, and urine samples for research testing

●Operated and instructed in patient use of personalized hand-held questionnaire devices

●Performed phlebotomy blood draws, urine collection, and sample processing

Regulatory Affairs Coordinator – University of Colorado Anschutz October 2019-January 2020

Hematology Solid State Tumor

●Composed Protocol and ICF documentation for study start up through Western IRB and Colorado Multiple IRB

●Submitted amendments, protocol deviations, unanticipated events and adverse events

●Utilized OnCore study program for document sharing, billing, and coordination

●Regulatory contact person for start up, ongoing trials, and study close out

●Scheduled and facilitated monitoring visits and study audits

●Wrote clear and accurate informed consent and HIPAA documents

●Participated in Data Safety Monitoring Committee (DSMC) internal audits

●Performed start up, maintenance, and closure of Investigator Initiated Trials

●Submitted and updated all required regulatory bodies including:

oColorado Multiple Institutional Review Board (COMIRB)

oProtocol Review and Monitoring System (PRMS)

oHospital Research Support Services (UCH-RSS)

oUniversity of Colorado Hospital Biosafety Committee (IBC)

oUniversity of Colorado Hospital Clinical Trials Research Center (CTRC)

●Assisted with TMF preparation for closeout

Senior Clinical Research Coordinator – Denver Esophageal and Stomach Center January 2019-July 2019

●Initiated study protocol CHIRB submissions and amendments

●Screened, enrolled, processed, and completed follow up with research participants

●Coordinated Allergan’s Pledge study with Relamorelin medication for gastroparesis

●Completed GCP, CITI, and study specific trainings

●Coordinated interdisciplinary study projects, including InBody body composition pre-surgical testing

●Utilized Oracle’s InForm EDC for Allergan’s eCRF documentation

●Worked from Intergy and EPIC EMR for chart review, candidate screening, and patient correspondence

●Recorded and reported AE, SAE, and PD in timely fashion and accordance with regulations

●Kept up to date regulatory binders, and filed regular continuing reviews

●Coordinated with industry sponsors and facilitated site initiation and monitoring visits

●Developed SOPs for office study practices

●Prepared budgets and study feasibility analysis for new trials

●Managed office database for all patients and procedures

●Organized and performed postoperative outcomes questionnaires and data collection

●Developed data collection, management, analysis, and supply storage plans

●Assisted with conflict of interest analysis and reporting

●Program implanted stimulators utilizing Medtronic N’Vision technology

●Received, stored, and dispensed research inventory including chain of custody records

●Pursued and obtained Phlebotomy certification for study necessitated blood draws

●Collected ECG, blood draws, and urine samples for research testing

●Operated and instructed in patient use of personalized hand held questionnaire devices

●Performed blood glucose monitoring for diabetes monitoring

●Coordinated with StudyKiK, MedX, and Acurian participant recruitment organizations

Clinical Research Coordinator – University of Utah Orthopedics November 2017 – December 2018

Shoulder/Elbow

●Coordinated 20+ studies at any given time including sponsored, investigator initiated, grant funded, retrospective, and prospective studies

●Coordinated investigator initiated, industry sponsored, and grant funded studies such as the NIH and MLB

●Participated in study startup, including budgeting, IRB protocol drafting, and grant submission

●Managed uTRAC research billing software incorporated with EPIC EHR

●Recruited participants via chart review and community outreach

●Processed protocol deviations, adverse events, and regulatory documentation

●Completed GCP, CITI, and RATS certificate trainings

●Assisted with physician contracts and license updates

●Recruited, oriented, supervised, and evaluated the regulatory performance of students on studies

●Created and maintained REDCap EDC software for designing clinical and translational research databases

●Coordinated value driven outcome projects for financially focused studies

●Performed retrospective electronic data warehouse requests and processed results

●Utilized EPIC EHR to register, schedule visits, and medical image orders for participants

●Served as the focal contact for multi-site and interdepartmental studies, including genetic and the VA

●Collected genetic material and facilitated multi department processing of samples

●Recorded video, electromagnetic readings, and motion capture for research data values

●Coordinated patient recruitment video for a complicated NIH trial

●Performed publication review and submission to research journals

●Participated in AAOS 2018 research conference

●Coordinated Zimmer Biomet’s Biowick SURElock study

●Assisted with cadaver dissection for validation studies and facilitated scheduling of resources for cadavers

●Processed large population outcome studies with data manipulation and basic statistical analysis

●Composed, submitted, amended, and conducted continuing reviews of IRB protocols

●Assisted with Compassionate Use study including FDA submission and sponsor implant specifications

●Supported other team’s time sensitive recruitment efforts and lab sampling

●Operated, stored samples, and coordinated maintenance for -80 DNA freezer

●Utilized mEVAL database management SQL to process PROMIS queries

●Extensively utilized Excel to compile data for retrospective research on multiple investigator initiated queries

Medical Billing Specialist – nCenter June 2016 – September 2017

Counseling

●Processed daily medical insurance claims and entered EOB payments

●Utilized ICD-10 coding procedures and diagnoses for billing submission

●Served as a resolution specialist in collecting outstanding claims from both clients and medical insurance

●Directed the office through a software transition, reconciled file transfer, and established office specific procedures

●Coordinated third party auto insurance claims

●Reported payroll for both employee and contract workers

●Assessed timesheets for overtime hours and covered shifts for coworkers

●Transitioned team to TheraNest EMR

Neurofeedback Technician

●Assisted with the administration of quantitative electroencephalograms for diagnostic assessment

●Provided neurofeedback and neurostimulation treatments based on brain map results

●Researched and provided patient education on the neurostimulation treatments

Clinical Research Coordinator - Alpine Orthopedics and Sports Medicine October 2015-June 2017

Knee

Study Coordinator: NeoCart Research Study, Histogenics’ neocartilage autologous tissue implant

●Served as an educational outreach liaison for the community to learn about clinical trials and provide access to advanced treatment procedures for orthopedic articular cartilage knee injury

●Recruited patients through outreach events, social media mediums, and internal office research

●Screened, enrolled, and scheduled all patient care for enrolled subjects

●Coordinated research, surgical, billing, and clinical teams to comply with trial requirements

●Documented adverse events and protocol deviations observing GCP processes

●Complied with WIRB regulatory protocol, as well as compiling all research documentation

Medical Assistant - Bozeman Podiatry Clinic August 2015-April 2016

Podiatry

●Engaged with clients through their podiatric visit, from check in to pre-surgical preparation, to communication regarding home care

●Supported team members in administrative and billing duties, including patient calls and collecting patient bills

●Captured patient vitals, recorded patient histories, entered ICD-10 diagnoses and CPT coding

●Performed podiatric x-ray using OPAL-Rad systems

●Administered MicroVas neuropathy treatment and Ultrasound therapy

●Sent prescriptions, completed pre-surgical documentation, and coordinated with operating facility

●Sterilized surgical equipment and assisted with sterile technique for in-office surgical procedures and wound care

●Assisted with the crafting of orthopedic inserts from the casting of the foot to mixing of the mold to applying cushioned covers to the final product

Clinical Research Coordinator - Movement and Neuroperformance Center of Colorado June 2014-May 2015

Neurology

Study Coordinator: INTREPID Research Study, Boston Scientific’s Deep Brain Stimulation Vercise device

●Engaged with patients suffering Parkinson's Disease and offered them the cutting edge treatment available through the research trial

●Assisted principal investigators to screen, enroll, treat, and retain research patients

●Performed troubleshooting for research, administrative, and protocol details

●Organized patient recruitment scheduling, coordinated travel, reported protocol deviations and adverse events, provided patient reimbursements and stipends, as well as submitted and filed study data

●Entered source documentation and case report forms for multiple team members through the study's EDC MEDIDATA Rave

●Promoted research events and patient education seminars across Colorado, engaging potential patients in their testimonies and personal experiences with Parkinson's

●Identified and maintained WIRB regulatory updates and submissions, maintaining stellar data records

●Obtained prior authorizations for and communicated research protocol with patient medical insurances

●Coordinated Boston Scientific field representative and monitoring staff communications and site visits

●Served as a liaison between many office to coordinate the Deep Brain Stimulation operations

●Maintained research material on site, scanning proprietary research devices into service

●Set up equipment and performed research videos of research visits to empirically track client progress ultimately for study publication

Clinical Associate: Coordinated multiple doctors clients, collected patient vitals, recorded patient health history, reconciled records for pre-surgical candidates, facilitated physician patient communications

Cognitive Behavioral Program: performed MOCA, Cognistat, NPI, ALD, BAI, LAI evaluations and created an assessment system to provide the neurologist with data to make diagnostic evaluations

Patient Events: Coordinated and participated in patient education events across the Rocky Mountain Region for Parkinson’s disease, Essential Tremor, and Dystonia diseases, as well as Deep Brain Stimulation treatment

Medical Assistant - Colorado Brain and Spine Institute August 2013-June 2014

Neurosurgery

●Recruited to support neurosurgeon Dr. Adam Hebb and his numerous unique neurosurgical procedures treating Parkinson's disease, essential tremors, dystonia, trigeminal neuralgia, brain cancer, as well as spine and brain injury

●Scheduled patients, gathered their medical records from numerous sources, and communicated Dr. Hebb's techniques in layman's terms

●Collected patient vitals, provided medical imaging, prepared chart notes, scheduled subsequent operations

●Managed physician clinic schedules, including meetings, research visits, and interdisciplinary collaborations

●Coordinated multiple offices for implant operations, including external neurology staff and device representatives

●Served as point staff for the clinic for the INTREPID Deep Brain Stimulation research trial

●Administered and participated in educational outreach events for Deep Brain Stimulation surgical options

Professional Skills Profile

●Skilled collaborator and independent worker

●Strong interpersonal and customer service skills

●Proficient verbal, written, and video communication

●Organized and attended Patient Events for recruitment and education

●Marketed using social media including Facebook, Twitter, and Instagram

●Coordinated participant and professional travel

●Observed GCP research process in all aspects of work

●Collected point of sale payments

●Managed timesheet submissions and payroll

●Capable and often recruited to cover coworker’s projects

●Experienced in Microsoft Outlook, Word, Excel, Adobe InDesign, and PowerPoint

●Trained in Basic SQL and database languages

●Skilled with EHR software including EPIC, TheraNest, My Clients, Plus eClinicalWorks, HealthFusion, Chart Logic, Office Ally, Centricity, and Intergy

●Utilized research uTRAC, REDCap, RAVE, iMedNet, and Prosoft EDC systems

●Proficient with IRB submission through ERICA system as well as extensive work with the WIRB regulatory requirement

Publications

Chalmers, P. N., Beck, L., Stertz, I., Aleem, A., Keener, J. D., Henninger, H. B., & Tashjian, R. Z. (2018). Do magnetic resonance imaging and computed tomography provide equivalent measures of rotator cuff muscle size in glenohumeral osteoarthritis? Journal of Shoulder and Elbow Surgery,27(10), 1877-1883. doi:10.1016/j.jse.2018.03.015

Chalmers, P.N., Kahn, T.K., Broschinsky, K., Ross, H., Stertz, I., Nelson, R., Yoo, M., Tashjian, R. (2019). An analysis of costs associated with shoulder arthroplasty. Journal of Shoulder and Elbow Surgery, https://doi.org/10.1016/j.jse.2018.11.065.

Chalmers, P.N., Beck, L., Miller, M., Stertz, I., Hennginger, H.B., Tashjian, R.Z. (2019). Glenoid Retroversion Associates with Asymmetric Rotator Cuff Muscle Atrophy in Those With Walch B-type Glenohumeral Osteoarthritis. American Academy of Orthopaedic Surgeons, https://insights.ovid.com/crossref?an=00124635-900000000-99286

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