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Clinical Research Site Manager

Location:
Parkville, MO
Salary:
85,000
Posted:
November 01, 2023

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Resume:

JASON COLBERT, MS

**** ** ****** ** * Phone: 480-***-****

Parkville, MO 64152 Email:ad0sku@r.postjobfree.com

www.linkedin.com/in/jason-colbert-aa22351a8

Objective: I am an enthusiastic, highly organized clinical research professional. I have experience in overseeing both clinical and regulatory operations, as well as managing multiple research sites and teams. I apply my experience as a trial / site manager, in conjunction with my Master of Science degree in Clinical Research Management, to make valuable contributions as a coordinator, site manager, or trial manager to an organization that fosters diversity and inclusion as core values of company culture and clinical research trials.

Education: Arizona State University: Edson College of Nursing and Health Innovation2020-2021 (MS)

• Master’s degree in clinical research management (MS-CRM) Arizona State University: Edson College of Nursing and Health Innovation 2017-2020 (BS)

• Bachelor of Science Degree in Public Health (BS) Academic Honors

• Valedictorian - Selected by the Dean of the Edson College of Nursing and Health Innovation at Arizona State University to speak at our convocation ceremony to represent my graduating class and the public health and health innovation degree programs.

• Board member for the master’s degree program in Clinical Research Management at Arizona State University.

Employment: Arizona Liver Health: Research Site Manager October 2023 – present

• Data management – EDC entry / source creation / transcribe data

• Conduct subject research study visits

• Quality control and Quality assurance for site

• Direct report for employees on site

• Informed consent / collect, process, and ship lab samples

• Collect vital signs arthrometric measurements, transient elastography, EKGs

• Audit research trials / prepare site for FDA Audit and monitor visits

• Communicate site status with upper management, train, and conduct weekly meetings with employees

University of Kansas Medical Center: Supervising Clinical Research Coordinator February 2021 – October 2023

Oversee all regulatory and clinical operations for clinical trials in the Department of Ophthalmology

• Regulatory and IRB submissions

• ICF and screening patients

• Conduct all patient visits including follow up visits

• Ensure accurate data collection / blood draw / aliquot samples in accordance to protocol

• Source, EDC, CRF, QC, and eCRF data maintenance and transcription

• Training back-up coordinators and staff on study procedure JASON COLBERT, MS

Care Access: Regional Site Manager, Integrated Research Organization January 2022- July 2023

• Ensure protocol is maintained by following subjects through screening and randomization to completion of all study visits

• Responsible for Quality at the Site Level

• Coordinate Projects, Resources, and Timelines.

• Interviewing Potential Employees

• Audit Prep / Quality Control / Conducting SEVs / Weekly 1:1 / Study Progress Presentations

• PI engagement at all sites

• Site Development Planning

• Liasson Between Research Teams and Upper Management

• Added as a CRC to all studies

Arizona Research Center: Clinical Research Coordinator March 2020– January 2021

• Lead coordinator on multiple studies

• Screening and follow up visits

• Coordinate surgical floor post-op, consultations, and schedule surgical procedures

• Unblinded Pharmacist

• A variety of EDC systems, CRF, ICF, and source documents

• Vital signs: Blood draw/ 12 lead ECG/ blood pressure/ pulse oximeter/ laboratory procedures / investigational drug prep

• Medical terminology

Systems: Veeva / Medidata Rave / Oracle / Epic / Clinical Conductor / Study Teams / Firecrest / Q2 Soultions / Endpoint IRT / IWRS / Sharepoint / MS Excel / MS Word / MS PowerPoint / Outlook / Slack / MS Teams / CRIO / Fusion Live / Sensor Push / ERT Global / Workday / Greenphire / Clinical Ink / Infasario Quintiles / Complete Consent / Google Slides / Expensify / Salesforce / Advarra IRB / WCG IRB / SIP / Trial Master / Florence / PEDIG / DRCR Network / DARC / Longboat Indications:

• Oncology

• Alzheimer’s

• COPD

• Ophthalmology / pharmaceutical and device

• Diabetes / peripheral neuropathy / retinitis pigmentosa / AMD

• Orthopedic / Orthopedic surgery and Device trials

• Stem Cell / PRP

Certifications:

• HIPPA Regulations in Clinical Research

• GCP

• Ethics and Human Subjects Protection in Clinical Research

• Dangerous Goods Shipping and Handling (IATA)

• Human Subjects Training / biomedical



Contact this candidate