Jenee' Neil
Atlanta,GA
Summary
Detail oriented professional experienced in clinical research with extensive experience in managing clinical trials, site monitoring, ensuring adherence to protocols, maintaining regulatory compliance and managing clinical trials from initiation to close out. Excellent organization and time management skills with demonstrated metrics and exceptional KPI's. Demonstrates methodical and results-driven approach to ensure high-quality data collection and reporting, resulting in successful project outcomes.
Overview
10
10
years of professional experience
Work History
Clinical Research Associate II
ICON
11.2023 - Current
- Managed 8-10 oncology sites in the eastern region with Amgen FSP.
- Perform management of study site activities to ensure the integrity of clinical data, in adherence to all applicable regulatory guidelines.
- Assist team in the development of site recruitment and retention strategy.
- Initiate contact with Principal Investigators (PIs), schedule and conduct pre-visits, assess potential investigators and recommend suitability of the site.
- Assesses data generated by R&D/Business Teams.
- Serves as key contact to assigned clinical sites throughout the study process.
- Serve as co-monitor for studies for SDV backlog.
- Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Complete monitoring reports for SIV and interim monitoring.
- Adhere to monitoring plan and schema per protocol.
- Collaborated with cross-functional teams to successfully meet project timelines and deliverables.
- Maintained effective communication with investigators regarding project timelines, protocol amendments and other related matters while ensuring adherence to GCPs.
Clinical Research Associate
IQVIA
02.2022 - 11.2023
- Confirmed subject eligibility, enrollment and patient oversight for oncology trial patients on in alignment with Roche FSP.
- Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Implemented electronic data capturing systems to adhere with clinical research guidelines.
- Perform monitoring visits according to monitoring plan (including qualification visits, study initiation, training and closeout activities).
- Point of contact for sites and facilitator of communication between sites and sponsor.
- Guide and support investigational sites on assigned projects.
- Ensure preparation, collection and distribution of study master file documents.
- Set up and ensure maintenance of investigator site file.
- Timely write-up of study monitoring visit reports.
Clinical Research Coordinator
The Ascent Group
Conyers, GA
01.2021 - 11.2021
- Input research study data for Phase III clinical trial sponsor , Astrazeneca
- Successfully enrolled over 20 patients for COVID19 Astrazeneca Vaccination trial
- Maintain quality control for content, accuracy, and completeness
- Prepare and maintain research study files
- Compile, collate and submit study information within established deadlines
- Assist in maintenance of regulatory documentation
- Schedule subject visits and generate appropriate reports and documents for research subjects prior to visits
- Input visit data into Clinical Trial Management System (CTMS) to track patient visits and procedures completed against study budget
- Processing of required lab specimens, labeling of vials, and accurately filling out requisitions for storage and/or shipment per study protocol and packaging and shipment regulations
- Perform various administrative support functions such as reception, office organization, and office supply management
- Verify and/or correct research study information on source documents. Research queries and variances, and provide feedback to site data collector
- Perform veni- puncture
Clinical Research Coordinator
Morehouse School Of Medicine
Atlanta , GA
04.2019 - 12.2020
- Assisted in enrolling over 30 patients weekly for NIH funded trial.
- Assisted in enrolling and maintaining on time patient visits and data for sponsor oncology studies.
- Responsibilities involve patient registration, data collection, data submission, adverse event reporting, patient follow-up, records management, regulatory reporting and quality assurance
- Participates in sponsor correspondence, monitoring, and study meetings.
- Collaborate with ordering providers to ensure patients are on track for subsequent treatments.
- Collected, processed and delivered specimens from trial participants.
- Conducted informed consent presentations for NIH studies and maintained documentation.
- Assists in the development and completion of source documents and case report forms
- Participate in recruitment and outreach: Identify and compile lists of potential research participants in accordance with study objectives and parameters, as appropriate to the individual position.
- Conduct and record face-to-face and/or telephone interviews with subjects, in accordance with predetermined interview protocol, data collection procedures and documentation standards.
- Provide ready access to all experimental data for faculty researchers and/or supervisor.
- Monitors compliance throughout all study activities and engages compliance oversight as needed
- Utilized comprehensive knowledge of ICH-GCP and FDA regulations to ensure compliance with study protocols.
- Created and maintained clinical trial documentation, including case report forms, informed consent forms and regulatory documents.
- Communicated with laboratories and investigators regarding laboratory findings.
- Schedules study-specific visits in conjunction with ancillary departments
- Maintains equipment and supply resources for research studies
Phlebotomy Technician
Crisp Regional Hospital
06.2018 - 04.2019
- Collecting blood samples from patients, labeling them and dispatching them for analysis and testing
- Transporting blood samples to the correct laboratory
- Performing laboratory tests
- Assembling medical equipment, such as blood collection devices, tourniquet, needles, cotton and trays
- Entering data into laboratory and hospital data systems
- Maintaining patient confidentiality according to applicable laws
- Obtaining appropriate medical information from patients
- Monitoring patient glucose levels by performing bedside glucose tests
- Collecting blood specimens through veni-puncture and skin puncture
- Assisting in the training of students and new employees
- Ensuring appropriate equipment and supply usage
- Validated blood and specimen collection orders, alerting nurses or physicians of discrepancies between order and nursing station logs
- Accurately labeled tubes with patient name, date and time of collection
- Spoke with patient to gather information for lab records, reduce their fear or anxiety, and optimize their cooperation
Medical Scribe - Emergency Medicine
Scribe America
01.2018 - 04.2019
- Accompanied physicians during patient consultations and documented patient history and physical exam findings accurately into the electronic medical record.
- Organized and transcribed results for patients' laboratory tests, medications and imaging studies.
- Documented procedures completed and recorded diagnostic test results.
- Documented all diagnoses, treatment plans, prescriptions, and discharge and follow-up information.
- Documented HPI, PMH, ROS and bedside physical examination on EPIC.
- Transcribed all ancillary test results, including any lab tests, imaging tests, ECGs, and ABGs.
- Reviewed prior medical records to obtain PMH, prior labs, ECG and radiographic studies for comparison.
- Prepared patient charts prior to physician consultation.
Certified Nursing Assistant
Phoebe Putney Memorial Hospital
02.2017 - 06.2018
- Displayed strong clinical skills in assessing vital signs, performing lab draws and glucose checks, and providing pre- and post-operative care to medical - surgical and oncology patients.
- Adhered to safety guidelines; completed hospital's three-hour Patient Safety Training Program.
- Ensured the accurate, timely flow of information by maintaining thorough patient records and updating healthcare team on patients' status.
- Complied with HIPAA standards in all patient documentation and interactions.
- Performed patient assessments, documented vital signs and reported changes to supervisors.
- Monitored fluid outputs, documented results and collected specimens for testing.
- Reviewed organization functions to stay up-to-date on procedures.
- Educated patients and families regarding examination, treatments, and surgical procedures.
- Exercised comatose, paralyzed, and immobile patients.
- Utilized PPE appropriately and followed patient safety and infection control guidelines.
- Assisted patients with personal hygiene tasks, such as bathing and dressing, while maintaining respect for patient privacy and dignity.
Quality Assurance Laboratory Technician
Tara Foods
02.2017 - 05.2018
- Maintains computerized scale system by keeping units operational and current with formulations; monitoring and verifying records.
- Maintains factory processes and procedures to standard by using statistical and other laboratory methods for monitoring and charting; notifying production supervisor of noncompliance.
- Prepares experimental design projects by mixing test batches in laboratory.
- Releases materials by evaluating all results and visual inspection methods; determining status of non-shippable or usable material.
- Maintains quality service by following organization standards.
- Maintains stock of forms and spare parts by verifying inventory of items; notifying laboratory manager when items are needed.
- Maintains safe and healthy work environment by following organization standards and legal regulations.
Direct Support Professional
Albany Advocacy Resource Center
01.2016 - 01.2017
- Developed rapport with patients to create a safe and trusting environment for care.
- Assisted disabled clients in any way necessary to facilitate independence and well-being.
- Maintained a clean, safe and well-organized patient environment.
- Monitored progress and documented any status changes accordingly.
- Attended scheduled medical appointments with patients.
- Completed documentation in log books, journals and care plans to document accurately report patient progress.
- Supervised daily activities and provided assistance when needed.
- Administered medication as directed by physician.
- Assisted patients with bathing, dressing, hygiene and grooming.
- Took and recorded patients' temperature, pulse and blood pressure.
Education
Bachelor of Science - Biology
Albany State University
GeorgiaSkills
- Microsoft Office Word
- Microsoft Office Excel
- Microsoft Office PowerPoint
- Code of federal regulations (CFR)
- Clinical data management
- Phase I,II,III Oncology
- CAR-T, Solid tumors
- Phase III Obesity/ Chronic weight management
- Strong verbal and written communication skills
- Strong quantitative and analytical skills
- Understanding of ICH/GCP
- Understanding of SOP's
- Proficient knowledge of medical terminology
- Proficient in using electronic medical records databases (EPIC, OncoEMR)
- IMedidata Rave ( EDC)
- SAE reporting
- CTMS
- Trial master file
- IRT Platforms
- IRB Submissions
- Regulatory compliance and systems
- Investigational product management
- Analysis and management of clinical data
- Excellent organizational skills
- Investigational product accountability
- Source document verification, source document review
- Report writing
- Drug development
- Informed consent
- Specimen collection and sample management
- study vendors ( Labcorp, clario, WCG, clincard)
- Veeva vault
- Site IP database( vestigo )
- Attention to detail
- Time management
- Quality assurance
- Adverse event tracking
- Relationship building, Communication
Additional Information
Registered Phlebotomy Technician, AMT :Certified Nursing Assistant : CPR/AED
Timeline
Clinical Research Associate II
ICON
11.2023 - Current
Clinical Research Associate
IQVIA
02.2022 - 11.2023
Clinical Research Coordinator
The Ascent Group
01.2021 - 11.2021
Clinical Research Coordinator
Morehouse School Of Medicine
04.2019 - 12.2020
Phlebotomy Technician
Crisp Regional Hospital
06.2018 - 04.2019
Medical Scribe - Emergency Medicine
Scribe America
01.2018 - 04.2019
Certified Nursing Assistant
Phoebe Putney Memorial Hospital
02.2017 - 06.2018
Quality Assurance Laboratory Technician
Tara Foods
02.2017 - 05.2018
Direct Support Professional
Albany Advocacy Resource Center
01.2016 - 01.2017
Bachelor of Science - Biology
Albany State University