MARCO TOLBERT
Birmingham,AL
Summary
Detail-oriented Clinical Research Associate well-versed in coordinating operations, managing sites and drafting detailed clinical reports. Knowledgeable about action planning, database locking and standard operating procedures. Supports participant recruitment and management to meet research objectives.
Overview
6
6
years of professional experience
Work History
Clinical Research Associate II
Thermo Fisher Scientific Clinical
Wilmington
08.2022 - Current
- Reviewed informed consent, medical records, data entry, clinical data collection in the clinical systems, vendor supplies, EDMS, confidentiality of medical record, source documentation, case report forms and investigative site regulatory files to verifies accuracy and completion for Vaccines, Respiratory and Immunology phase III studies
- Implemented electronic data capture in the clinical systems to adhere reliability with clinical guidelines
- Conduct site visits including initiation, monitoring, and closeout visits, maintain expense reports to verifies study procedures, regulatory documents and data completion and provide training to site staff
- Work cross-functional with the team includes, clinical study site management lead, ihcra SMS and sponsor to troubleshoot and provide solutions to study-related issues and vendor issues
- Followed drug storage Pharmacovigilance and security procedures to comply with protocols, ICH-GCP, and SOP requirements
- Monitor safety of human subject/patient advocacy and oversaw consent procedures
- Process improvement to comply with local and federal regulations
- Manages site monitoring scheduling to facilitate effective communication with members of clinical
- Traveled to investigative sites to conduct risk basked monitoring for site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance with status report
- Submitted site management routine MVR reports and follow-up letters to facilitate internal and external Liaised with clinical investigator to identify root cause analysis clinical report, assess and resolve site performance, consultation, global quality regulation, data integrity, data reporting, risk assessment and compliance issues.
- Reviewed and track participant eligibility and consent documentation to help researchers achieve accurate and meaningful results as applicable.
- Organized and maintained research study regulatory documents in site binder QMS to maintain accuracy and data integrity.
- Apart of a mentoring team
- Completed a Sponsor sites audit inspection with no findings.
- Monitored safety events reported during the course of clinical trials in accordance with SOPs.
Clinical Research Associate I
IQVIA
Durham
05.2021 - 08.2022
- Monitor Phase I Double Blinded study of oncology solid tumor and Phase II ophthalmology studies
- Oversee Serious Adverse Event (SAE) reporting activities per safety regulations, including coordinating with the Principal Investigator to ensure transparency of adverse events for the IRB
- Assist in investigator study, regulatory submissions, including negotiating study budgets, site selection and study start-up
- Create clinical project documents according to the protocol, including, but not limited to, source documentation forms and guidelines, monitoring Standard Operating Procedures (SOPs), monitoring visit templates and approved reports as applicable
- Completes on-site monitoring visits to confirm protocol compliance, assess qualifications of study personnel, ensure 'Good Clinical Practice', and conduct close-out visits as applicable
- Identify site issues and initiates correction plans based on monitoring reports
- Perform and track investigative site file reconciliation requests any new and updated site-related essential and non-essential documents and reviews them for content, consistency with other approved documents, and compliance with appropriate local regulatory requirements, ICH guidelines, business writing standards, Project Standard Operating Procedures (SOPs), and sponsor requirements
- Verifies subject/patient data in source documents are in agreement with source, initiate data query resolution and confirm resolution in timely manner as applicable
- Ensure subject/patient safety and adverse event reporting to sponsor and IRB/IEC Local regulations
- Conduct reviews to verifies logistics drug accountability logs, vendor invoice and storage requirements
- Provide study status reports to discuss key performance indicators, CRM lead
- Line management, Clinical Operations lead and Project Management, ihcra lead based on the project s to facilitate project timeliness.
Clinical Project Coordinator II
Covance
Nashville
05.2019 - 05.2021
- Assessed study progress and identified potential risks or delays in order to develop strategies for mitigation.
- Generated timelines for protocol development, database lock, submission filing activities, and other milestones.
- Assessed clinical policies and procedures for compliance with changing regulations
- Scheduled and facilitated meetings between project stakeholders to discuss deliverables, schedules and conflicts and action/ issue logs during start up activities
- Maintained open communication by presenting regular updates on project status to customers including potential risk and devised contingency plans
- Managed patient care and clinic services and handled financial management, quality assurance, safety and risk management and facility maintenance.
- Facilitated resolution of conflicts between different stakeholders involved in a given project.
- Interacted with external vendors such as central laboratories, contract research organizations, imaging centers to coordinate services related to a given trial.
- Prepared budgets for each trial including resource allocation across all sites involved in the study.
- Negotiated contracts with vendors regarding cost estimates and service levels required for successful execution of studies.
- Conducted periodic meetings with stakeholders to review project status and address any issues that may arise.
- Collaborated with internal departments such as regulatory affairs, pharmacovigilance, data management, medical writing, biostatistics. to ensure successful completion of projects.
Clinical Data Coordinator
Vanderbilt University Medical Center
Nashville
06.2018 - 05.2019
- Oncology Liquid Tumors /Therapeutic area Phase I-III
- Identified discrepancies between collected data and original source documents; resolved issues by working with investigators or other staff members.
- Coordinated with internal stakeholders during audits conducted by sponsors or regulatory agencies.
- Generated customized reports from CDMS based on sponsor requests.
- Maintained source documents such as patient records, laboratory results, and medical histories.
- Reviewed case report forms for accuracy and completeness according to protocol specifications.
- Followed standard operating procedures to perform quality control audits.
- Ensured compliance with applicable regulatory standards including GCP and ICH guidelines.
- Monitored patient safety reports submitted by investigators throughout clinical trials.
Education
Bachelor of Science - Public Health, Health Professions
The University of Alabama
05.2018
Skills
- Regulatory Document Review
- eTMF (Veeva)/CTMS
- Research and Development
- Patient Safety
- Project Management
- Patient Recruitment
- Site Management
- Protocol Development
- Good Clinical Practice
- Excellent Communication
- Quality Assurance
- Attention to Detail
- Relationship Building
Timeline
Clinical Research Associate II
Thermo Fisher Scientific Clinical
08.2022 - Current
Clinical Research Associate I
IQVIA
05.2021 - 08.2022
Clinical Project Coordinator II
Covance
05.2019 - 05.2021
Clinical Data Coordinator
Vanderbilt University Medical Center
06.2018 - 05.2019
Bachelor of Science - Public Health, Health Professions
The University of Alabama
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