LaQuanda Suitt
Douglasville
Summary
Experienced Clinical Team Lead with over 13 years' experience working in clinical research and managing operational aspects of clinical trials. Excellent skills and knowledge of clinical trial operations with experience in various therapeutic indications.
Highly skilled Clinical Trial Manager with strong background in overseeing all aspects of clinical trials, from planning to execution. Possess a deep understanding of regulatory guidelines and Good Clinical Practice (GCP). Strengths include strategic trial design, data management, and patient safety protocols. Previous roles have highlighted ability to optimize resources for efficient operation of clinical trials and successful attainment of research objectives.
Overview
16
16
years of professional experience
Work History
Clinical Trial Manager
Syneos Health
Raleigh
03.2021 - 12.2024
- Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity
- Managed site interactions post activation through site closeout for study phases II, III and IV
- Regional CTM experience: United States and Canada
- Global Unblinded CTM Experience: Europe
- Ensured quality of the clinical monitoring, central monitoring and site management deliverables within a project and maintain proper visibility of its progress by the use of approved systems and / or tracking tools
- Reviewed the study scope of work, budget and protocol content and ensures the clinical project team is aware of the contractual obligations and parameters
- Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables
- Escalated to the project manager any risks to clinical trial management deliverables (timeline, quality and budget) and any activities and requests which are out of contracted scope
- Participated and presents in key meetings such as Kick Off Meetings
- Served as an escalation point for communications with investigator site staff and may be required to interact on the phone or in person with principal investigators or other site staff members
Lead Clinical Research Associate
Syneos Health
Raleigh
04.2020 - 03.2021
- Supported primary study Clinical Lead in routine reviews of Clinical Trial Management System (CTMS), Case Report Form (CRF), drug management, safety, Trial Master File (TMF), IVRS/IWRS enrollment, Data Visualization dashboards (where available) to oversee site and study team conduct, to ensure timely entry of all operational aspects (required visits/calls, duration, and frequency) according to plan
- Assigned site and study team members' conduct and identifies risks to delivery or quality
- Ensured quality of the clinical monitoring and site management deliverables within a project and maintain proper visibility of its progress using approved systems and / or tracking tools
- Understood the monitoring strategy required for the study and, where required, participates in the development of the study risk assessment plan
- Accounted for their assigned clinical team members' understanding, ongoing compliance, and delivery according to the stated monitoring strategy, CMP/SMP, and risk plans
- Reviewed the content and quality of site monitoring documentation (site monitoring calls, site visit reports, site letters, and pertinent correspondence), to ensure they represent site management activities and conduct
Senior Clinical Research Associate II
Syneos Health
Raleigh
02.2018 - 04.2020
- Performed site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and protocol compliance
- Verified the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate
- Reviewed the Investigator Site File (ISF) for accuracy, timeliness, and completeness
- Performed investigational product (IP) inventory, reconciliation and reviews storage and security
- Reconciles contents of the ISF with the Trial Master File (TMF)
- Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations
- Documented activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan
Senior Clinical Research Associate
ICON
Brentwood
02.2015 - 02.2018
- Responsibilities included identification, selection, initiation, and close-out of investigational sites for clinical studies
- Monitored those sites in order to ensure that studies are carried out according to the study protocol, ICON SOPs/WPs, applicable regulations and the principles of ICH-GCP
- Involved, when required, in other areas of study management and staff training
- Contributed to the review of ICON systems and procedures, as appropriate
- Coached and mentored monitoring competence to inexperienced/less experienced colleagues
Senior Clinical Research Associate
Quintiles
Marietta
04.2014 - 02.2015
- Conducted evaluation, initiation, and routine monitoring and close out visits at each assigned study site
- Instructed investigator site staff in their responsibilities and ensures compliance with GCP and ICH guidelines
- Managed several study protocols at one time
- Identified quality and performance improvement opportunities and collaborated with site staff
- Provided instruction, retraining and management to site staff
- Reviewed regulatory documents, investigational product accountability and Case Report Form source document verification
- Prepared/Completed confirmation/follow-up letters and site visit reports
Clinical Research Associate
Quintiles
Marietta
11.2011 - 04.2014
- Conducted site-level clinical trials set forth in the protocol, patient recruitment and retention, feasibility, site monitoring and general compliance
- Handled the tasks of ensuring that the integrity and quality of data collected in the organization sponsored clinical trials
- Performed responsibilities of ensuring adequate protection of the rights of all subjects involved in company sponsored clinical trials
Senior Clinical Trials Assistant
Quintiles
Marietta
07.2011 - 11.2011
- Assisted clinical study sites to assure adherence to Good Clinical
- Knowledgeable in GCPs, SOPs, and study protocols
- Processed investigator site invoices and problem-solving outstanding payments
- Mentored and trained newly hired and seasoned clinical staff in daily tasks when applicable
Clinical Trials Assistant
Quintiles
Marietta
09.2008 - 07.2011
- Harmonized documentation of site compliance/performance globally and relays information to clinical and project management teams
- Initiated the submission of pertinent documents to regulatory bodies and ethics committees and tracks status until trial completion
- Delivered sponsor correspondences to participating investigator sites and relays team communications accordingly
- Coordinated the preparation and distribution of clinical supplies on a global scale
- Performed assisted site monitoring visits as well as attends sponsor led team meetings when applicable
Education
Bachelors of Science - Biology
Bloomfield College
United States01.1999
Skills
- Site selection
- Customer focus
- Clinical trial oversight
- Clinical monitoring
- Feasibility analysis
- Training and mentoring
- Investigator relations
- Results-oriented
- Patient recruitment
- Audit preparation
- Adverse event reporting
- Document review
- GCP training
- Ethics committee submissions
Therapeutic Experience
- Cardiovascular - Lipidemia
- Gastroenterology - Constipation, Chronic
- Gastroenterology - Constipation, Opioid-Induced
- Infectious Disease - Infection, COVID-19
- Infectious Disease - Infection, Influenza A
- Infectious Disease - Infection, Influenza B
- Immunology
- Neurology - Huntington's Disease
- Psychiatry - Depression
- Psychiatry - Schizophrenia
- Respiratory - Bronchiectasis
- Urology - Overactive Bladder
Biography
Experienced Clinical Team Lead with over 13 years' experience working in clinical research and managing operational aspects of clinical trials. Excellent skills and knowledge of clinical trial operations with experience in various therapeutic indications.
Timeline
Clinical Trial Manager
Syneos Health
03.2021 - 12.2024
Lead Clinical Research Associate
Syneos Health
04.2020 - 03.2021
Senior Clinical Research Associate II
Syneos Health
02.2018 - 04.2020
Senior Clinical Research Associate
ICON
02.2015 - 02.2018
Senior Clinical Research Associate
Quintiles
04.2014 - 02.2015
Clinical Research Associate
Quintiles
11.2011 - 04.2014
Senior Clinical Trials Assistant
Quintiles
07.2011 - 11.2011
Clinical Trials Assistant
Quintiles
09.2008 - 07.2011
Bachelors of Science - Biology
Bloomfield College