Clinical Research Associate
Resume:
Carol Tunsil
USA-Florida-Home-Based Senior Clinical Research Associate
Lake City, FL 32055
Biography
Ms. Carol Tunsil, Senior Clinical Research Associate, has been working in Clinical Research for more than 14 years. Prior to joining Syneos Health, she held positions as a Senior and a Clinical Research Associate. She has a broad background in clinical trials management of Phase I/II/III trials in various indications including the implementation of study protocols, monitoring of sites and on-site data management and collection. She has significant expertise in remote data entry (EDC). She also has experience with both paper and electronic methods of data capture. She has been a Senior Clinical Research Associate at Syneos Health since 2021. These experiences have culminated in Carol Tunsil translating unique insights into outcomes, helping biopharmaceutical customers shorten the distance from lab to life.
Professional Experience
Present Syneos Health/Home-Based – Lake City, FL (Contracted with Abbvie)
Sr CRA I
-Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
-Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
-Per the Clinical Monitoring/Site Management Plan (CMP/SMP):
oAssesses site processes
oConducts Source Document Review of appropriate site source documents and medical
records
oVerifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records
oApplies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines
oUtilizes available hardware and software to support the effective conduct of the clinical study data review and capture
oVerifies site compliance with electronic data capture requirements
-May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
-Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. 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.
-Documents 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. Supports subject/patient recruitment, retention and awareness strategies.
Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
-Understands project scope, budgets, and timelines for own and others’ activities in the clinical team; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets.
-May act as primary liaison with project site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
-Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates, and may, with supervision, lead, global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
-Provides guidance at the site and project level towards audit readiness standards and supports
preparation for audit and required follow-up actions.
-May provide training or mentorship to more junior level CRAs. May perform training and sign off visits for junior CRA staff, as assigned.
-May be mentored and assigned clinical operations lead tasks under supervision of an experienced Clinical Operations Lead (COL), or operational line manager.
-For Real World Late Phase (RWLP), the Sr. CRA I will use the business card title of Sr. Site Management Associate I. Additional responsibilities include:
oSite support throughout the study lifecycle from site identification through close out
oKnowledge of local requirements for real world late phase study designs
oChart abstraction activities and data collection
oAs required, collaborate and build relationships with Sponsor and other affiliates, medical science liaisons and local country staff
oIdentify and communicate out of scope activities to Lead CRA/Project Manager
oProactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations
oIdentify operational efficiencies and process improvements
oDevelop country level informed consent forms
oCollaborate with RWLP Regulatory team to ensure updated regulatory information is applied and shared
oParticipate in bid defense meetings.
Nov 2021 – March 2023 PPD (Contract)
Senior Clinical Research Associate
Provided monitoring, planning, organization, communication and implementation of study objectives for assigned protocol(s) as a lead member of the team.
Perform clinical on-site monitoring activities (drive patient recruitment, source data verification, drug accountability, data collection)
Collect regulatory documentation.
Perform qualification, initiation, monitoring and termination of investigational sites.
Jun 2021 - Nov 2021 ICON
Senior Clinical Research Associate
Provided monitoring, planning, organization, communication and implementation of study objectives for assigned protocol(s) as a lead member of the team.
Perform clinical on-site monitoring activities (drive patient recruitment, source data verification, drug accountability, data collection)
Collect regulatory documentation.
Perform qualification, initiation, monitoring and termination of investigational sites.
Dec 2015 - Jun 2021 IQVIA
Senior Clinical Research Associate
-Perform site selection (if applicable), initiation, monitoring, and close-out visits in accordance with contracted scope of work and good clinical practice.
-If applicable, may be accountable for supporting development of project subject recruitment
plan on a per site basis. Work with sites to adapt, drive and track subject recruitment plans in line with project needs to enhance predictability.
-Provide monitoring visits and site management for a variety of protocols, sites, and therapeutic areas.
-Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
-Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
-Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support project/site start-up phase.
-Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
-Act as a mentor for new clinical staff including conducting co-monitoring and training visits.
-May provide assistance with design of study tools, documents and processes.
-Convey features and opportunities of study to site. - Collaborate
and liaise with study team members for project execution support as appropriate.
Sep 2014 - Nov 2015 Parexel
Senior Clinical Research Associate
Provided monitoring, planning, organization, communication and implementation of study objectives for assigned protocol(s) as a lead member of the team.
Perform clinical on-site monitoring activities (drive patient recruitment, source data verification, drug accountability, data collection)
Collect regulatory documentation.
Perform qualification, initiation, monitoring and termination of investigational sites.
Feb 2011 – Sep 2014 Clintech Solutions
Senior Clinical Research Associate 2013-2014
Clinical Research Associate 2011 – 2013
Provided monitoring, planning, organization, communication and implementation of study objectives for assigned protocol(s) as a lead member of the team.
Perform clinical on-site monitoring activities (drive patient recruitment, source data verification, drug accountability, data collection)
Collect regulatory documentation.
Perform qualification, initiation, monitoring and termination of investigational sites.
June 2008 – Feb 2011 VA Medical Center
CNA
Provided for activities of daily living by assisting with serving meals, feeding patients as necessary and ambulating, turning, and positioning patients; and providing fresh water and nourishment between meals.
Feb 1998 – Jun 2008 Suwannee Healthcare
CNA
Provided for activities of daily living by assisting with serving meals, feeding patients as necessary and ambulating, turning, and positioning patients; and providing fresh water and nourishment between meals.
Therapeutic Experience
Cardiovascular - Angina Pectoris, Stable
-Heart Failure, Congestive
-Hypertension
-Myocardial Infarction
Device - Heart Failure Device (Central Venus Access)
Endocrinology/Metabolism - Diabetes Mellitus, Type 1
-Diabetes Mellitus, Type 2
Gastroenterology - Crohn's disease
Oncology - Cancer, Squamous Cell Carcinoma
Respiratory - Allergy
- Asthma
- COPD
Neurology - Depressive Disorder
- Botox Migraine
- Pediatric Migraine
- Epilepsy
Ophthamology - Dry eye
Infectious Disease - COVID-19
Languages
English - Speaking, Reading, Writing
-Native
Education
Currently Jacksonville Theological Seminary - United States
Master’s in Theology
2010 Lake City Community College - United States
Business Associates Degree
1998 Lake City Community College - United States
Certified Nursing Certification
1997 Columbia High School - United States
High School Diploma
1995 Jacksonville Theological Seminary - United States
Bachelor – Theology
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