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Sr. Clinical Research Coordinator

Location:
Cincinnati, OH
Posted:
September 28, 2024

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Resume:

Shannon R. Chambers

*** ********* *****

Taylor Mill, KY 41015

859-***-****

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

Organized and motivated employee with 18+ years experience in the healthcare profession. I have been employed by a Research facility for the last 7 years. I am able to apply organizational skills in various environments and seek employment in a professional atmosphere.

EXPERIENCE

February 2019-CURRENT

Wellnow Urgent Care & Research, 10575 Springfield Pike Cincinnati, OH- Clinical Research Coordinator

Initiate research protocols, implement new technology, monitor patients

Oversee the clinical trial protocol, CRF’s, and informed consent

Update departmental procedures and legal requirements to keep the team and department current

Prepares IRB submissions including continuing reporting, reportable events, amendments and follow ups to IRB

Maintain confidential HIPAA standards with all Patient documents

Ascertain all FDA and IRB policies are met in relation to various protocols

Ensure coordinator and investigator compliance with GCP and ICH guidelines

Produce site-specific advertising materials using Sponsor and IRB approved language

Train CRC’s, nurses, and clinical staff on clinical trial processes and protocol guidelines

Create source documents for various protocols

Maintain all required documentation for the study protocol and for FDA regulations ensuring accurate completion of all technical requirements.

Serve as main point of contact for study related questions including subject eligibility

Process specimens’ study specific per protocols, package and ship specimens per protocol

Ensure study medication is kept secure and under the appropriate temperature conditions and maintain accurate study drug accountability

November 2015-February 2019

Medpace, 5355 Medpace Way Cincinnati, OH- Sr. Research Assistant

Assist with study participant screening, admission, orientation, informed consent, conduct, and discharge

Demonstrate technical skills in Phlebotomy, laboratory specimen collection, ECG’s, vital signs, drug screens and other protocol related procedures

Process specimens’ study specific per protocols, package and ship specimens per protocol

Perform routine lab and exam room maintenance such as equipment calibration, waste disposal, and preparation of patient areas

Notify appropriate project team members of study participant Adverse Events in a timely manner

Follow proper safety and emergency policies and procedures, and notify direct supervisor of potential work hazards

Maintain accurate and legible logs and tracking sheets

Maintain study specific documents

Train new employees

Work side by side with Investigators and Pharmaceutical sponsors

Assist in the overall process of clinical trials

August 2005-February 2011

St. Elizabeth Medical Center, 1 Medical Village Drive Edgewood, KY- Phlebotomist

Maintained patient lab work

Occupied positions at Inpatient, Outpatient, and Nursing Homes

Collected blood and other specimens for multiple ranges of testing

August 2001-July 2005

Cardiology Associates, 900 Medical Village Drive Edgewood, KY-Receptionist

Maintained scheduling of patients

Assisted with co-pays, registration, and medical records

EDUCATION

May 2001-May 2002

Southwestern College, Florence KY- Phlebotomy

References Available Upon Request



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