Randolph Worsley III, CCRP
Apex,NC
Summary
Focused and results driven Study Start Up & Primary CRA II with prior experience as a Sr. CRC and study lead. Specializing in Oncology, Precision Medicine, Neurology, Inflammation and Cardiology with 10+ years experience. Seeking a challenging and responsible position to contribute knowledge, experience, and leadership in clinical research. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
Overview
8
8
years of professional experience
1
1
Certification
Work History
Start Up/Primary Clinical Research Associate II
DOCS Global/ICON - Amgen FSP
04.2020 - Current
- As Primary CRA II under Amgen FSP. Monitored clinical trials across southeast US. Primary monitoring activities included performing Site initiation visits, monitoring visits, site contacts and close out visits. Source data verification and review for sites. Worked with both pediatric and adult oncology trials (Phase I-IV), cardiovascular, neurology, inflammation and dermatology. Other duties include activating multiple sites, collecting start up documents (DOA logs, IIR Forms, NSST trainings) for activation, assisting sites with query resolutions, investigator signatures, open site issues and pages via CTMS (eClinical, CRIMSON). Sites included multiple universities and academic institutions, hospitals, government facilities (NIH) and research centers around southeast and northeast. Managed and activated multiple sites to reach study milestones successfully.
- As Study Start Up CRA II under Amgen FSP, study start-up responsibilities included performing site evaluation visits and submitting in-depth SEV reports. Reported site qualifications to data feasibility managers, local trial managers while recommending sites for selection. Compiled start up site documents for eTMF submission and site activation (Site contact forms, EMR/EDC surveys and checklists, Source Document Identity, CLIA/GCP certifications), providing support to CTA's during regulatory documentation collection, conducting site transitions to primary CRA’s. Provided training and mentorship to incoming CRA's. Also facilitated vendor access to site staff (RAVE/Medidata, CTMS, IVRS, local labs etc.), providing site updates and statuses to study teams during weekly LST calls, collecting and reviewing PI CV's and staff training certifications. Prompted IRB submission and supported SCBA's for contract/budgeting negotiations. Submitted and reviewed Trial Master File documents, conducted feasibility COLA calls for potential sites (NIH). Provided start up materials (IP and kit tracking, EDC access for staff) for selected sites. Also approved multiple RGL (Regulatory Green Light) and SQGL's (Site Qualification) packages via VeevaVault. Managed over 20 sites, successfully activating them, while accomplishing many study goals (50-75% PSA's, FSA's) and milestones including receiving multiple accolades such as spotlight and kudos awards.
Senior Clinical Research Coordinator
Children's Healthcare of Atlanta
08.2018 - 04.2020
- Aflac Precision Medicine Program (APMP) Lead coordinator at both Egleston and Scottish Rite campuses. Spearheaded program and trial start up creating regulatory documents and processes. Assisted PI's in creating general flow algorithms and conduct of program. Conduct clinical trial using Next Generation Sequencing (NGS) via Ashion. Consent and enroll recurring and refractory solid tumor, Leukemia, and brain tumor patients to APMP after screening. Coordinate pathology specimen requests, processing specimens, and germline blood or saliva sample collection via clinic and inpatient unit. Genetic reports generated from Ashion analytics sent directly to me then disseminated to patients primary physicians, clinical team and families. Enter genetic data from reports into EDC. Organize and create agenda of patients to be discussed and mentioned at our Molecular Tumor Boards. Assist with program budgeting and payments of invoices as well as study amendments and SOP's. Adhere to standards in all areas, including data collection, research protocols and regulatory reporting. Successfully led key points in the development of program which resulted in a large number of enrollments beyond expectation and positive results during first year.
- Coordinator for Pediatric MATCH (COG) Phase II Developmental Therapies trial and Compassionate Use Studies
Clinical Research Coordinator - Oncology
Children's Healthcare of Atlanta
02.2016 - Current
- Hematology/Oncology Aflac Cancer & Blood disorders center; Maintained data pertaining to research projects, completing source documents/case report forms, performing data entry of patient abstracted information in to EMR systems; discussing and consenting patients for research studies, preparing research case reports in quantitative measures and narrative form; reviewing medical records and conduct screening for recruitment of study participants; assisting with quality assurance and tracking regulatory submissions; interfacing with study sponsors, monitoring and report Serious Adverse Events, resolving study queries; and collecting and processing study specimen including tissue, bodily fluids, and other pathological specimens according to research protocol; study start up and site visits for investigator initiated studies, set up monitoring visits and SIV's
- Coordinated Solid Tumor/Rare Tumor Clinical Trials (COG) Phase II-III, Leukemia/Lymphoma Clinical Trials (COG) Phase III-IV, and Developmental Therapies Clinical Trials (Aflac) Phase I-II
Clinical Research Assistant
Atlanta Center for Medical Research, ACMR
03.2015 - 03.2016
- Created and maintained screen books and charts for all assigned studies, Prepared and ran study visits, ensured accuracy of source documents and assessments, Filing of lab results, EKG results, and designated charts, Completed data entry for all eCRFs, as well as paper CRF completion and transmission, Completion of headers, Assisted Coordinators in assessments, blood pressure and urine drug screens, Assisted Coordinators with scheduling, copying, faxing, and other clerical tasks. Aided Coordinators in the facilitation of study monitoring visits
- Conducted Medical as well as Psychology clinical trials Phase III-IV for respiratory, cardiovascular, and mental disorders
Education
Master of Science - Clinical Research
Morehouse School of Medicine
Atlanta Georgia2015
Bachelor of Science - Biology-Chemistry
Winston-Salem State University
Winston-Salem2012
Skills
- Study start up to site close out
- Phase I-IV Oncology Clinical Trials
- Performing Monitoring Visits (IMV,COV)
- Conducting SIV's SEV's & COLA's
- QA following GCP, FDA guidelines
- Completion and review of eCRF's/queries
- Preparing for FDA audits
- Expert presentation skills
- Accomplished team leader
- Regulatory tracking, reviewing and approving RGL/SQGL's
- Data collection & analyzation using CTMS
- Employee training and mentorship
Accomplishments
- Precision Medicin/NGS (Phase I-IV)
- Neuroblastoma (Phase I-IV)
- Leukemia/Lymphoma (Phase I-IV)
- CNS Brain Tumors (Phase I-IV)
- Wilms Tumor (Phase I-III)
- Rhabdomyosarcoma (Phase II-IV)
- Retinoblastoma (Phase II-IV)
- Osteogenisis Imperfecta (Phase II)
- Osteosarcoma/Ewings Sarcoma (Phase I-IV)
- HPV Vaccine Trials
- Multiple Myeloma (Phase II)
- NSCLC and Small Cell Lung Cancer (Phase II-III)
- Colon (Phase II-III)
- Pancreatic (Phase II)
- CNS (Phase II-III)
- Lupus (SLE)
- ASCVD (Phase IV)
- Dyslipidemia (Phase IV)
- Migraine (Phase III-IV)
- Schizophrenia (Phase III-IV)
- Bipolar Disorder (Phase II-IV)
- Asthma (Phase III-IV)
- Influenza (Phase III)
Oncology, US
Pediatric Cancer
Adult Cancer
Inflammatory, US
Cardiology, US
Neurology, US
Psychiatry, US
Respiratory, US
Infectious Disease, US
Conferences/Publications
- 2020 Next-Generation Sequencing Reveals Increased Prevalence Of PICALM-MLLT10 Fusions In T-ALL And T-LLY 2020
- 2016-2019 Children's Oncology Group (COG) Conference, Atlanta Ga
- 2015 Worsley, R "Meta-Analysis of dietary primary preventions for Colorectal cancers incidence in high risk African Americans" AACR Special Conference on Metabolism and Cancer
- 2012 Worsley, R "The Synthesis of Piperidines as Potential Medications for Cocaine Addicts" Scholars Day, Winston-Salem State University
Certification
- CCRP Certified Clinical Research Professional, 2020 SOCRA
- BLS/CPR certified through American Heart Association, 2020
Affiliations
- Member, Society of Clinical Research Associates (SOCRA CCRP) (2017-present)
- Member, American Association for Cancer Research (AACR) (2015-2017)
- Member, Children's Oncology Group Member (2016-present)
- Member, Kappa Alpha Psi Fraternity, Inc. (2011-present)
Timeline
Start Up/Primary Clinical Research Associate II
DOCS Global/ICON - Amgen FSP
04.2020 - Current
Senior Clinical Research Coordinator
Children's Healthcare of Atlanta
08.2018 - 04.2020
Clinical Research Coordinator - Oncology
Children's Healthcare of Atlanta
02.2016 - Current
Clinical Research Assistant
Atlanta Center for Medical Research, ACMR
03.2015 - 03.2016
Master of Science - Clinical Research
Morehouse School of Medicine
Bachelor of Science - Biology-Chemistry
Winston-Salem State University
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