Shanna Cobble
Summary
19 years of experience working in clinical research, with 9 years of experience as a Line Manager or Clinical Trial Manager and 10 years of experience as a Clinical Research Associate or Clinical Research Assistant
Overview
24
24
years of professional experience
Work History
Manager, Clinical Operations
ICON Clinical Research
11.2020 - Current
- Effectively manage people in client specific roles of the FSP model, ensuring high performance, quality delivery of client objective, and continuous development of direct reports
- Ensure timely identification, resolution, and escalation of issues
- Ensure completion of induction and orientation for newly hired direct reports
- Ensure client-specific induction and orientation is planned, communicated and completed
- Establish goals and objectives for each assigned direct report
- Monitor performance and conduct annual appraisal for each direct report, as applicable
- Conduct regular 1:1 meetings with assigned direct reports
- Ensure timely submission and approval of time reports, expense reports and leave requests for assigned direct reports
- Create a positive relationship between ICON, the direct reports and the client to ensure retention
- Implement, monitor and ensure appropriate completion of a Corrective Action Plan, if required
- Establish routine teleconference and meeting schedule with client contact(s) to effectively manage client relationship
- Obtain regular client feedback to ensure direct reports are meeting performance expectations
- Collaborate with client to forecast resource requirements
Clinical Trial Manager
ICON Clinical Research
11.2015 - 11.2020
- Acted as the Functional Lead from Clinical Research Services with responsibility for delivery of all clinical aspects of clinical studies
- Oversaw and served as the liaison between the Project Manager and a group of Clinical Research Associates (CRAs) assigned to a given clinical study
- Delivered all aspects of monitoring and site management
- Ensured consistency with ICH/GCP and applicable ICON Standard Operating Procedures (SOPs), applicable regulations, and the Monitoring Plan
- Ensured the clinical portion of the study was inspection ready at all times
Clinical Research Associate (EL to Principal)
ICON Clinical Research
08.2006 - 11.2015
- Identified, selected, initiated, and closed appropriate investigational sites for clinical studies
- Monitored those sites in order to ensure that studies were carried out according to the study protocol, ICON SOPs/WPs, applicable regulations, and the principles of ICH-GCP involvement, when required, in other areas of study management and staff training.
- Contributed to the review of ICON systems and procedures, as appropriate
- Coached, mentored, and assessed monitoring competence of inexperienced/less experienced colleagues.
- Contributed to the culture of process improvement with a focus on streamlining our processes, adding value to our business and meeting client needs
- Recognized, exemplified, and adhered to ICON's values which center on a commitment to People, Clients, and Performance
- Independently and proactively coordinated the necessary activities required to set up and monitor a study
- Ensured audit inspection readiness
Clinical Research Assistant
ICON Clinical Research
02.2006 - 08.2006
- Set-up, organized, and maintained clinical study documentation (e.g. TMF)
- Conducted project tracking and maintenance of the CTMS
- Coordinated, dispatched, and tracked study materials
- Coordinated Investigator payments
- Generated study communications, including newsletters and meeting minutes
- Acted as the primary point of contact for the clinical team for any administrative issues, requests, or queries
Associate Scientist
Midwest Research Institute
03.2005 - 02.2006
- Trained incoming and existing personnel in analysis methods and ensured they had read and understood appropriate SOPs
- All other Assistant Scientist tasks
Assistant Scientist
Midwest Research Institute
01.2004 - 03.2005
- Performed DNA extraction and purification
- Analyzed samples using PCR and ECL
- Maintained reagent and control stocks
- Maintained databases and reviewed data and reports
- Performed cleaning and safety techniques to ensure a sterile environment. Maintained and troubleshot instrumentation as needed
- Assisted in the development of SOPs and methods
Senior Research Assistant
Meharry Medical College
07.2002 - 07.2003
- Trained incoming personnel and graduate students
- All other Research Assistant tasks
Research Assistant
Meharry Medical College
07.2001 - 07.2002
- Performed DNA extraction and purification using several methods including commercial kits and agarose and polyacrylamide gel electrophoresis
- Performed western blots
- Performed recombinant protein expression and purification using amylose resin columns
- Performed standard PCR
- Maintained cell lines using tissue culture
- Isolated bacteria
- Maintained laboratory supplies
- Performed maintenance and troubleshooting of equipment
Education
Bachelor of Science - Biology, Emphasis in Microbiology
Middle Tennessee State University
Murfreesboro, TN12-2000
Therapeutic Areas
Endocrine Disorders
Cushing Syndrome
Eye Disorders
Diabetic Macular Edema
Retinitis Pigmentosa
Gastrointestinal Disorders
Irritable Bowel Disorder – Constipation
Infections and Infestations
Bacterial and General Infections and Infestations
Bacterial Vaginosis
Musculoskeletal and Connective Tissue Disorders
Fibrodysplasia Ossificans Progressiva
Osteoarthritis
Nervous System Disorders
Alzheimer's Disease
Angelman's Syndrome
Epileptic Encephalopathy
Oncology
Small Cell Lung Cancer
Psychiatric
Major Depressive Disorder
Renal and Urinary Disorders
Urinary Tract Infection – Uncomplicated (uUTI)
Vaccines
Anthrax
Cytomegalovirus
Human Papilloma Virus
Influenza (Seasonal and Pandemic), including special populations
Pneumococcal, including special populations
Rotavirus
Smallpox
Varicella Zoster, including special populations
Timeline
Manager, Clinical Operations
ICON Clinical Research
11.2020 - Current
Clinical Trial Manager
ICON Clinical Research
11.2015 - 11.2020
Clinical Research Associate (EL to Principal)
ICON Clinical Research
08.2006 - 11.2015
Clinical Research Assistant
ICON Clinical Research
02.2006 - 08.2006
Associate Scientist
Midwest Research Institute
03.2005 - 02.2006
Assistant Scientist
Midwest Research Institute
01.2004 - 03.2005
Senior Research Assistant
Meharry Medical College
07.2002 - 07.2003
Research Assistant
Meharry Medical College
07.2001 - 07.2002
Bachelor of Science - Biology, Emphasis in Microbiology
Middle Tennessee State University
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