Lisa Parnell-Jones
Marietta,USA
Summary
Organized and dependable Senior Clinical Research Associate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals. Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy.
Overview
39
39
years of professional experience
1
1
Certification
Work History
Sr CRA II
Syneos Health
05.2022 - Current
- Responsible for monitoring all types of clinical trials; assures adherence to Good Clinical Practice, investigator integrity and compliance with all study procedures
- Primary responsibility is for site management and performance, including documentation
- Site management activities include all in-house and on-site monitoring for all visit types
- Served in lead CRA / Assistant Lead role
- Responsible for management and coordination of Clinical Research Associates (CRAs)/Central Monitors (CMs) on clinical research projects
- May participate in Business Development client presentations and bid defenses as requested.
Sr CRA
United Biosource Corporation (UBC)
06.2019 - 04.2022
- Thorough knowledge and application of project specific protocol
- Consistently completed on site monitoring in accordance with project specific timelines
- Consistently completed travel scheduling in accordance with project specific and UBC guidelines
- Attended project team meetings, department meetings and minimum of monthly 1:1 with manager; responsible for content of these meetings
- Consistently completed site monitoring reports, confirmation/follow-up letters per UBC and/or client SOPs; signed, scaned and/or provided to CSS/RDS for filing in Trial Master File according to UBC and/or sponsor timelines requiring minimal corrections
- Ensured follow-up of site issues and action items per UBC/sponsor timelines
- Enterd site visits, confirmation/follow-up letters and site monitoring reports into CTMS
- Ensured completion of Call Log or Telephone Contact Report detailing communication with sites per protocol
- Monitored within EDC data entry, if applicable, and assists sites with DCF resolution
- Completed Regulatory Binder and Investigational Product reconciliation.
Sr CRA
Covance Clinical Development Service
01.2012 - 06.2019
- Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned
- Responsible for all aspects of site management as prescribed in the project plans
- General On-Site Monitoring Responsibilities: Ensured the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
- Ensured the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review
- Ensured the resources of the Sponsor and Covance are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Covance travel policy
- Prepare accurate and timely trip reports
- Manage small projects under direction of a Project Manager/Director as assigned
- Serve as lead monitor for a protocol or project and may assist in establishing monitoring plans as assigned.
Senior Clinical Research Associate
PPD
07.2010 - 12.2011
- Performed and coordinated assigned aspects of the clinical monitoring process in accordance with GCPs and global SOPs to assess the safety and efficacy of investigational products and/or medical devices
- Conducted site visits to determine protocol and regulatory compliance, and prepare required documentation
- Developed collaborative relationships with investigative sites and client company personnel.
Associate Manager of Clinical Operations
Quintiles, INC
02.2007 - 10.2009
- Provided line management for a team of office-based CRAs Clinical Operations personnel in the conduct of Phase I through Phase III clinical trial projects
- Oversaw the development of clinical staff by teaching, mentoring and performing six-month and annual performance evaluations, as well as attended multiple on-site support and assessment visits for CRAs
- Monitored overall workloads of direct reports
- Identified training needs of direct reports through the creation and ongoing assessment of the training plan and records
- Accompanied each CRA on site monitoring visits and complete assessment of on site monitoring performance
- Reviewed expense reports and timesheets; tracked vacation, sick leave, and non-billable time
- Served as source of scientific and therapeutic expertise for Quintiles Clinical staff
- Served as liaison between Quintiles, Inc
- Project teams and pharmaceutical clients
- Oriented new employees to Quintiles policies and procedures, Quintiles specific data bases, and other specific job responsibilities required for Quintiles CRAs.
Clinical Team Lead
Quintiles, Inc
11.2006 - 02.2007
- Provided line management for a team of office-based CRAs Clinical Operations personnel in the conduct of Phase I through Phase III clinical trial projects
- Oversaw the development of clinical staff by teaching, mentoring and performing six-month and annual performance evaluations, as well as attended multiple on-site support and assessment visits for CRAs
- Monitored overall workloads of direct reports
- Identified training needs of direct reports through the creation and ongoing assessment of the training plan and records
- Accompanied each CRA on site monitoring visits and complete assessment of on site monitoring performance
- Reviewed expense reports and timesheets; tracked vacation, sick leave, and non-billable time
- Served as source of scientific and therapeutic expertise for Quintiles Clinical staff
- Served as liaison between Quintiles, Inc
- Project teams and pharmaceutical clients
- Oriented new employees to Quintiles policies and procedures, Quintiles specific data bases, and other specific job responsibilities required for Quintiles CRAs.
Sr CRA
Quintiles Inc
04.2003 - 11.2006
- Responsible for on-site monitoring of clinical drug trials
- Ensured adherence to good clinical practices, investigator integrity, and compliance with all protocol requirements and study procedures
- Verified Case Report Forms (CRFs) against source documents for completeness and accuracy
- Reviewed regulatory documents for availability and accuracy
- Performed Clinical Trial Materials accountability
- Maintained communication with site personnel, project team, and sponsor.
CRA
Quintiles Inc.
08.2001 - 04.2003
- Responsible for on-site monitoring of clinical drug trials
- Ensured adherence to good clinical practices, investigator integrity, and compliance with all protocol requirements and study procedures
- Verified Case Report Forms (CRFs) against source documents for completeness and accuracy
- Reviewed regulatory documents for availability and accuracy
- Performed Clinical Trial Materials accountability
- Maintained communication with site personnel, project team, and sponsor.
CRA
Spectrx Inc
05.2000 - 02.2001
- Responsible for on-site monitoring of clinical drug trials
- Ensured adherence to good clinical practices, investigator integrity, and compliance with all protocol requirements and study procedures
- Verified Case Report Forms (CRFs) against source documents for completeness and accuracy
- Reviewed regulatory documents for availability and accuracy
- Performed Clinical Trial Materials accountability
- Maintained communication with site personnel, project team, and sponsor.
Site Director/Lead Study Coordinator
Georgia Neurology Associates
09.1998 - 12.1999
- Completed site management for all study activities and research personnel
- Responsible for coordination of clinical drug trials
- Ensured adherence to good clinical practices, and compliance with all protocol requirements and study procedures
- Completed Case Report Forms (CRFs) with information gathered in source documents for all subjects
- Maintained regulatory documents for availability and accuracy
- Performed Clinical Trial Materials accountability
- Maintained communication with project team, and sponsor.
Site Manager and Lead Study coordinator
Digestive Care Associates
09.1996 - 09.1998
- Completed site management for all study activities and research personnel
- Responsible for coordination of clinical drug trials
- Ensured adherence to good clinical practices, and compliance with all protocol requirements and study procedures
- Completed Case Report Forms (CRFs) with information gathered in source documents for all subjects
- Maintained regulatory documents for availability and accuracy
- Performed Clinical Trial Materials accountability
- Maintained communication with project team, and sponsor.
Study Coordinator
Georgia Allergy and Respiratory
06.1994 - 08.1996
- Responsible for coordination of clinical drug trials
- Ensure adherence to good clinical practices, and compliance with all protocol requirements and study procedures
- Completed Case Report Forms (CRFs) with information gathered in source documents for all subjects
- Maintained regulatory documents for availability and accuracy
- Performed Clinical Trial Materials accountability
- Maintained communication with project team, and sponsor.
Study Coordinator
Atlanta Medical Associates
09.1992 - 06.1994
- Responsible for coordination of clinical drug trials
- Ensure adherence to good clinical practices, and compliance with all protocol requirements and study procedures
- Completed Case Report Forms (CRFs) with information gathered in source documents for all subjects
- Maintained regulatory documents for availability and accuracy
- Performed Clinical Trial Materials accountability
- Maintained communication with project team, and sponsor.
Study Coordinator
Atlanta Allergy Associates
08.1987 - 07.1992
- Responsible for coordination of clinical drug trials
- Ensure adherence to good clinical practices, and compliance with all protocol requirements and study procedures
- Completed Case Report Forms (CRFs) with information gathered in source documents for all subjects
- Maintained regulatory documents for availability and accuracy
- Performed Clinical Trial Materials accountability
- Maintained communication with project team, and sponsor.
LPN Charge Nurse
University Hospital
06.1985 - 07.1987
- Administer Medications
- Oversee CNA staff
- Direct patient care.
Education
Diploma - Practical Nursing -
Augusta Technical College
Skills
- Regulatory Documents
- Good Clinical Practice- GCPs
- EDC
- CTMS
- Risk management and central monitoring
- Friendly, Positive Attitude
- Teamwork and Collaboration
- Medical Terminology
- Clinical monitoring
- Informed consent
- Customer Service
- Problem-Solving
- Time Management
- Attention to Detail
- Dependable and Responsible
- Excellent Communication
- Computer Skills
Therapeuticexperience
- Analgesia - Headache, Migraine
- Pain
- Analgesia-Migraine HA Pain, Pain in Bone Cancer
- Cardiovascular - Heart Failure, End Stage Hypertension
- Device - Diabetic Neuropathy Device
- Endocrinology/Metabolism - Diabetes Mellitus, Type 2
- Gastroenterology - Colitis, Ulcerative Gastroesophageal Reflux Disease Heartburn
- Infectious Disease - Infection, Community Acquired Pneumonia Infection, Helicobacter Pylori Infection, Nosocomial Pneumonia
- Neurology - Epilepsy Multiple Sclerosis Stroke
- Ophthalmology - Macular Degeneration, Age-Related
- Psychiatry - Addiction, Smoking Cessation Bipolar Disorder PostTraumatic Stress Disorder
- Respiratory - Asthma, Allergic Chronic Obstructive Pulmonary Disease, Rhinitis, Pulmonary Oncology
Certification
- Licensed Practical Nurse, 10/1985 thru 06/2006
- ACRP certified CRA (CCRA)
- Certificate of completion for Vaccine Academy
Biography
Lisa Parnell-Jones has 22 years of experience in clinical trials on Phase II-IV drug trials as a Clinical Research Associate, Senior Clinical Research Associate, Clinical Trial Lead, Associate Manager and currently functions as a Senior Clinical Research Associate II at Syneos Health. Lisa Parnell-Jones has an additional 11 years of experience as a Study Coordinator, Clinical Site Manager and Director of Site Management. These experiences have culminated in Lisa Parnell-Jones being an integral part of the Biopharmaceutical Acceleration Model (BAM), which is shortening the distance from lab to life.
Additional Information
- Experience using medical device in a clinical trial for a neurostimulator used for sleep apnea.
- Experience in one major pulmonary Oncology study for 1 year.
Timeline
Sr CRA II
Syneos Health
05.2022 - Current
Sr CRA
United Biosource Corporation (UBC)
06.2019 - 04.2022
Sr CRA
Covance Clinical Development Service
01.2012 - 06.2019
Senior Clinical Research Associate
PPD
07.2010 - 12.2011
Associate Manager of Clinical Operations
Quintiles, INC
02.2007 - 10.2009
Clinical Team Lead
Quintiles, Inc
11.2006 - 02.2007
Sr CRA
Quintiles Inc
04.2003 - 11.2006
CRA
Quintiles Inc.
08.2001 - 04.2003
CRA
Spectrx Inc
05.2000 - 02.2001
Site Director/Lead Study Coordinator
Georgia Neurology Associates
09.1998 - 12.1999
Site Manager and Lead Study coordinator
Digestive Care Associates
09.1996 - 09.1998
Study Coordinator
Georgia Allergy and Respiratory
06.1994 - 08.1996
Study Coordinator
Atlanta Medical Associates
09.1992 - 06.1994
Study Coordinator
Atlanta Allergy Associates
08.1987 - 07.1992
LPN Charge Nurse
University Hospital
06.1985 - 07.1987
Diploma - Practical Nursing -
Augusta Technical College