Overview
Work History
Education
Skills
Additional Information
Community Engagement
Timeline
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Jenee' Neil

Atlanta,GA

Overview

9
9
years of professional experience

Work History

Clinical Research Associate II

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11.2023 - Current
  • Managed 8-10 oncology sites in the eastern region.
  • 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 an 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
  • 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.
  • Collaborated with cross-functional teams to successfully meet project timelines and deliverables.
  • Monitored safety of human subjects and oversaw consent procedures to comply with local and federal regulations.

Clinical Research Associate

IQVIA
02.2022 - 11.2023
  • 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
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 when necessary

Clinical Research Coordinator

Morehouse School Of Medicine
04.2019 - 12.2020
  • Enrolled over 30 subjects weekly for clinical studies
  • Collect and analyze data while supporting team in developing research protocols
  • Attend project meetings
  • Updated and maintained information accuracy within patient database
  • Managed clinical research trials funded by the National Institute of Health
  • Collected, processed and delivered specimens from trial participants
  • Conducted informed consent presentations and maintained documentation
  • Adhered to standards in all areas, including data collection, research protocols and regulatory reporting
  • 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
  • Perform phlebotomy and sample collection
  • Prepare findings for publication and assist in laboratory analysis, quality control, or data management
  • Summarize project results, prepare progress reports and presentations
  • Provide ready access to all experimental data for faculty researchers and/or supervisor

Phlebotomy Technician

Crisp Regional Hospital
08.2018 - 01.2019
  • 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 - 01.2019
  • Accompanied physician during patient consultations and assisted in recording patient history and physical exam findings 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

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
  • 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

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.
  • Worked to improve and enhance patient lives through effective and compassionate care.
  • Maintained a clean, safe and well-organized patient environment.
  • Monitored progress and documented any status changes accordingly.
  • Transported individuals to medical appointments and other errands.
  • Completed entries 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.
  • Processed monthly reports for department performance.
  • 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
Georgia

Skills

  • Microsoft Office Word, Excel and PowerPoint
  • Code of federal regulations ( CFR)
  • Oncology solid tumor, CAR-T, Colon cancer, Non small cell lung cancer, Triple negative breast cancer with genetic deletion protocols
  • Pharmacokinetics
  • Strong verbal and written communication skills
  • Strong quantitative and analytical skills
  • Understanding of GCP, ICH and SOP's
  • Proficient knowledge of medical terminology
  • Proficient in using electronic medical records databases ( EPIC, OncoEMR )
  • Oncology, Early- Late development
  • Electronic data capture ( EDC rave ) , iMedidata , Red Cap , Realtime
  • SAE reporting
  • CTMS, Veeva, Study Hub, Lablink, Signant Health, WIRB, SIP Platforms
  • IRB Submissions and Regulatory compliance
  • Investigational product management
  • Analysis and management of of clinical data
  • Phases 1-4 Clinical trial management
  • Demonstrated initiative and excellent organizational skills

Additional Information

  • AWARDS & CERTIFICATIONS RECEIVED: , Registered Phlebotomy Technician , AMT : Certified Nursing Assistant : CPR/AED

Community Engagement

Physicians Care Clinic , Volunteer | July 2019 - present

  • Triage patients upon arrival
  • Maintain proper accuracy of patients chart
  • Take patients vital signs such as height , weight , blood pressure and temperature
  • Provide patients with education regarding current medical situation and reasoning for visit
  • Prepare patient medication orders for pharmacy directed by the provider

Timeline

Clinical Research Associate II

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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
08.2018 - 01.2019

Medical Scribe - Emergency Medicine

Scribe America
01.2018 - 01.2019

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

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Jenee' Neil