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Clinical Research Associate

Location:
Atlanta, GA
Posted:
November 15, 2023

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Resume:

SUMMARY

A highly experienced Senior Clinical Research Associate with considerable Local/ National/ International/ US / Global experience within the CRO / Pharmaceutical / Biotech / environment. Key experiences are within:

EXPERIENCE

Date From: January 2023- Present

Company Name: Icon

Job Title: Senior Clinical Research Associate

•Coordinates the processes of due diligence, site contracting and purchase order preparation invoice tracking

•Coordinates the collection of all the essential documents needed for the investigator initiation package (IP)

•Ensure all clinical site personnel are trained to study protocol, procedures, and local regulations

•Ship investigational devices and performs device accountability, as applicable

•Prepare for and execute on-site qualification, study initiation, interim monitoring and close-out visits at clinical sites as necessary to ensure study requirements are being fulfilled

•Conduct monitoring visits in compliance with the study specific Monitoring Plan, Standard Operating Procedures, Good Clinical Practices (GCP) and applicable government regulations and guidelines

•Collecting completed Case Report Forms (CRF) and collecting, confirming and auditing supporting documentation

•Maintain responsibility for site management for pre- and post-market studies ensuring successful conduct of clinical programs, and cross- functional strategies

Date From: April 2022- January 2023

Company Name: OnPoint Consulting

Job Title: Contract Senior Clinical Research Associate

•Maintains project tracking system of subjects and site information as applicable

•Participates in Investigators’ Meeting as designated by Project Manager

•Monitors with knowledge of quality/scope/;meline and budget parameters

•Works with the Clinical Manager (CM), Clinical Lead or equivalent to enhance and proactively manage site visits and trial issues during the monitoring phase

•Monitors the quality of clinical deliverables and addresses quality issues with the appropriate team member. Escalates appropriately and in a timely manner to the appropriate team member.

•Prepares day to day activities for monitoring of a clinical study and sets priorities per site.

•Prepares for and conduct on-site qualifications, study initiation, interim monitoring and close-out monitoring visits at investigator sites as required by clinical monitoring plan

•Maintains Trial Master File (TMF)/electronic Trial Master File (eTMF) as defined by the organization’s processes per filing guidelines. Has an understanding of the required essential documents according to ICH/GCP Section 8. Reviews site documents and verifies they are accurate, complete, current, and include required updates.

Date From: Sept. 2018- April 2022

Company Name: Premier Research

Job Title: Senior Clinical Research Associate

•Delivers quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan timelines

•Maintains submission of expenses according to travel and expense requirements within company guidelines

•Responsible for the validity, correctness, and completeness of the clinical data reviewed and collected at assigned sites as dictated by ICH GCP/ISO14155, protocol and client requirements

•Monitors (remote, onsite or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with specific country regulations

•Manages query resolution process with sites and Premier Research Data Management

•Participates in Investigators’ Meeting as designated by the Project Manager. Maintain communication with study sites as directed per CMP, and in agreement with the study site and complete documentation of contacts.

•Ensures site visit metrics and utilization are maintained as required and escalates available, me as necessary to line manager

•Review of IP accountability and applicable logs (subject and site level) as directed per the Clinical Monitoring Plan

Date From: May 2017 – Sept. 2018

Company Name: Syneos Health (INC Research)

Job Title: Senior Clinical Research Associate

•Prepares for and conducts on-site qualification, study initiation, interim monitoring, and close-out monitoring visits at investigator sites

•Escalates issues and feedback for the team

•Identifies confidential information and complies with global and local laws and guidelines

•Monitors the quality of clinical deliverables and addresses quality issues with the appropriate team member

•Maintains high level of attention to detail to ensure subject safety for our projects and delivery of quality data for our clients

•Acquire basic knowledge of disease or condition under study. Participates in available training offered to increase therapeutic knowledge

•Responsible for coaching and mentoring CRAs and providing input into their development. Responsible for mentoring CRAs for various aspects of work

•Monitored and co-monitored to support the CRA team in study start-up and data collection.

Therapeutic Area & Phase

Nervous System: Epilepsy, Multiple Sclerosis (Phase III)

Cardiovascular: Stroke, Hypertension (Phase II)

Dermatology: Acne, Psoriasis Phase II and Phase III), Vitiligo (Phase II)

Oncology: Solid Tumor, Hematology, Breast Cancer and Renal Cancer (Phase I-III)

EDUCATION

American Intercontinental University Atlanta, Ga Bachelors in Business: Year 2015

Argosy University Atlanta, Ga Master of Business Administration : Year 2018

BIOGRAPHY

Senior Clinical Research Associate

Tyree Murray is currently working as a Senior Clinical Research Associate for Icon. As a Senior CRA, Tyree manages all aspects of a clinical trial at all assigned clinical sites to ensure patient safety, adherence to appropriate safety regulations and data integrity. Prior to coming to Icon, Tyree held positions as a Senior Clinical Research Associate at Premier Research and Syneos.

Tyree has a primary and extensive background, he has experience with a wide array of therapeutic areas including: Nervous System, Cardiovascular, Dermatology and Oncology. Tyree’s experience includes Phase I-IV studies and expertise in Epilepsy, Multiple Sclerosis, Stroke, Hypertension, Acne, Psoriasis, Vitiligo, Solid Tumor, Hematology, Breast Cancer and Renal Cancer

Tyree is very knowledgeable with the Code of Federal Regulations concerning IND and IDE as well as ICH and GCP guidelines. Tyree received his B.S. in Business, from American Intercontinental University in Atlanta, Georgia. Tyree continued his education at Argosy University and graduated with his MBA.

Tyree has frequently helped assist to other CRA’s at challenging sites and provide SWAT help when needed. His attention to detail and ability to work with challenging sites have been noted and acknowledged by all companies he has had the opportunity to work with.



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