Abena C. Roberts
Hackensack,NJ
Overview
15
15
years of professional experience
Work History
Senior Clinical Trial Associate
Anthos Therapeutics
06.2023 - Current
- Works closely with Head of Clin Ops and legal to review and approve clinical trial agreements and route for signature
- Tracks study status, enrollment, regulatory documentation, and site start-up status for assigned clinical projects including review and approval of regulatory package for release of clinical supply
- Managed eTMF system, responsible for and/or aids CRO in set-up, maintenance, reconciliation, and archiving of electronic Trial Master Files
- Interacts with CROs, vendors, investigators, monitors and other external partners to provide information and resolutions for specific study requests and issues and escalates to CPM as needed
- Manages logistics and coordinates investigator meetings, CRO kick-off meetings, and vendor meetings along with CPM and external meeting planners
- Provided critical support during audits or inspections by promptly addressing any concerns raised by regulators or sponsors regarding trial conduct or documentation practices.
- Assisted in the preparation of high-quality regulatory submissions, including informed consent forms, ethics committee applications, and safety reports.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Managed investigational product inventory levels, ensuring adequate supply for all enrolled patients at each study location. (including EU, Canada)
Clinical Research Coordinator II
Elligo Health Research, INC
10.2023 - 03.2025
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Increased participant retention rates through proactive follow-up efforts and regular engagement activities.
- Trained new team members on essential clinical research protocols and procedures, promoting a culture of continuous learning.
Sr. Clinical Trial Associate
Beigene
01.2020 - 06.2022
- Served as a Global Clinical Trial Associate ensuring delegated components of clinical trials were executed to expected and specified defined quality standards
- Trial Master File specialist/submitting documentation to TMF (e.g., followed ALCOA + principles while in alignment with the DIA reference Model v3.0)
- Reviewed monitoring reports to check for adherence to clinical trial metrics while assessing clinical sites against clinical trial protocol specifications
- Conducted pre-study site visits, collected, and reviewed clinical data, and prepared evaluative reports
- Contributed to the development of robust study protocols by providing input on design elements, feasibility assessments, and operational considerations.
Clinical Research Coordinator Moderna Covid Clinical Trials
Hackensack University Medical Center
08.2020 - 05.2021
- Assisted and independently conducted literature reviews, as well as the appraisal and grading of evidence
- Collaborated with the research nurse coordinator in creating source documents
- Reported all adverse events, serious adverse events and SUSARS to sponsor and IRB(s)
- Served as primary study coordinator ensuring adherence to the research protocol and provided periodic updates to Principal Investigator on individual clinical study progress
- Responsible for ensuring appropriate follow-up on clinical study patients by maintaining patient records, reviewing active patient list for correct and current materials
- Drew blood for sample collection received and labeled analytical samples (e.g., blood, toxin and tissue)
Program Assistant/ Clinical Research Associate
Montefiore Einstein Center for Cancer Care
09.2010 - 07.2020
- Reviewed study specific ICFs, eligibility criteria and registered research patients in CTMS system
- Assisted Regulatory staff with scheduling, coordination, and preparation of external sponsor and internal monitoring visits
- Facilitated PI review of safety reports for all research protocols in the department
- Maintained study lists and prepared studies for shipments to off-site record management service
- Extracted data from CTMS for Investigator reports and publications
- Collected data to assist in developing data collection systems and compiled reports
- Assisted in patient recruitment efforts and screened potential study participants
- Assisted in the preparation and review of clinical protocols, eCRFs, study manuals, and additional study documents as requested by Clinical Trial Manager
- Independently developed CRA Training materials and Clinical Monitoring Plans for review with CRA Manager prior to implementation
Education
Master of Science - Clinical Research Management
Arizona State University
Tempe, AZ08-2023
Bachelor of Science - Behavioral Sciences
Mercy College
Dobbs Ferry, NY01.2018
Skills
- Investigational product management
- Informed consent process
- Regulatory submissions
- Electronic data capture
- Protocol amendments
- Monitoring visit reports
- Clinical operations
Timeline
Clinical Research Coordinator II
Elligo Health Research, INC
10.2023 - 03.2025
Senior Clinical Trial Associate
Anthos Therapeutics
06.2023 - Current
Clinical Research Coordinator Moderna Covid Clinical Trials
Hackensack University Medical Center
08.2020 - 05.2021
Sr. Clinical Trial Associate
Beigene
01.2020 - 06.2022
Program Assistant/ Clinical Research Associate
Montefiore Einstein Center for Cancer Care
09.2010 - 07.2020
Master of Science - Clinical Research Management
Arizona State University
Bachelor of Science - Behavioral Sciences
Mercy College
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