Clinical Research Coordinator

ANGELA B. WILLIAMSON

**** **** ***** ***, ***** Mountain, GA 30087

770-***-**** – *************@*****.***

PERSONAL STATEMENT:

A dedicated healthcare professional prepared to offer 10 years of clinical research experience with complete understanding of what it takes to be a leader by building collaboration with project team, and keeping team engaged by clear communication, giving the team a sense of purpose and consideration of everyone’s opinion and perspective. Comply with study protocols, standard operating procedures and good clinical practices. A practiced problem-solver with strong attention to detail, while ensuring the integrity of clinical studies and maintaining participant’s safety at all times. PROFESSIONAL EXPERIENCE:

Synexus Clinical Research – PPD/ThermoFisher, 03/2023 – Present Sr. Clinical Research Coordinator

Conducts multiple ongoing clinical trials of varying size and complexity involving human subjects.

Accurately collects all data information as specified by protocol on case report forms (CRFs) and/or electronic (CRFs). Report all adverse events (AEs) and safety adverse events (SAEs), protocol deviations, and corrective and preventive actions (CAPAs) to Sponsors and Investigator Review Board (IRB).

Interacts with the research site team and other interdepartmental staff. Engage in the entire site operations process which includes recruitment, enrollment and retention of study participants.

Lead coordinator for assigned studies taking the overall responsibility at the site, liaising with monitors and other stakeholders.

Conducts clinical studies according to FDA/GCP and ICH regulations and guidelines.

Ensure participants fully understands the study and the informed consent process and answer all questions and concerns.

Screen and review participant’s eligibility according to the inclusions/exclusions criteria.

Distribute and review for signature; regulatory documents, safety reports, newsletters, and sponsor correspondence maintained in Electronic Investigator Site Files (eISF) study binder utilized in Complion.

Ensures that IRB approval is obtained and requirements are met, prior to study initiation and throughout the study.

Complete study startup tasks for assigned studies to include regulatory documents, delegation logs, sponsor documents, trainings completed and uploaded for all staff.

Receive and account for study devices during pre and post study, maintain Investigational Products (IP) accountability logs, individual subjects’ IP accountability log, dosage compliance log, and lab kits.

Schedule monitoring visits, file pre and post monitoring letters, prepare subject binders and/or eCRFs in preparation for monitoring visit. Complete findings prior to next scheduled visit.

Schedule subject visits within protocol window, ensuring required staff availability.

Perform clinical study assessment (i.e., screening, consenting, and protocol procedures which include but not limited to vital signs, pregnancy tests, height, weight, ECG's, blood samples, etc.).

Document all patient information to include demographics, medical history, concomitant medications, results from laboratory tests (blood draws, urine, vaccines) as specified per protocol.

Maintain ambient/frozen refrigerator temperature logs for temperature excursions if it should occur, throughout study.

Promote and builds a positive relationship with patients to ensure retention.

Coordinate and schedule Site Initiation Visit (SIV) meetings to prepare site on conducting the study.

Reviews the SOPs for policies and procedures for company and study conduct. Identify and communicate any obstacles impeding inefficiencies.

Monitors safety and well-being of all study participants through direct and indirect interaction, and communicates problems to relevant stakeholders.

Assists in the training of new team members and provides mentoring. Winship Cancer Institute of Emory University – Hematology/Oncology Melanoma/Neuro, 07/2021 – 03/2023 Clinical Research Coordinator III

Implemented, and followed clinical study protocols and managed multiple studies independently.

Developed communication and build relationships with sponsors, PIs, and patients to ensure the safety and integrity of the study trial.

Managed studies from project startup to project closeout, tracked studies and participants status, reported these details at weekly departmental meetings.

ANGELA B. WILLIAMSON

6423 Pine Ridge Way, Stone Mountain, GA 30087

770-***-**** – *************@*****.***

Facilitate Quality Management Monitoring (QM), Data Safety Monitoring (DSMC), to ensure studies are FDA ready for audits.

Managed and coordinated clinical trial activities and played a critical role in the conduct of study start-up to study closeout.

Ensured all clinical activities are conducted in compliance with protocol as well as all applicable laws, regulations, policies, and procedural requirements.

Adhered to the GCP standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials.

Screened and review participant’s eligibility for the study according to the inclusions/exclusions criteria.

Coordinated patient care oncology activities regarding weekly treatments, laboratory and diagnostic procedures according to study protocol, such as collection & processing of blood/urine specimens, and ECGs.

Acted as liaison and participants advocate for establishing and maintaining communication with Investigators, research staff, and sponsors.

Resolved study related problems and prioritize workload to meet deadlines, reported and documented abnormal laboratory levels.

Responsible for study completion processes including database lock, study closeout, reporting and archiving of study files.

Oversees data management in sponsor’s assigned electronic data management systems to include Oracle, iMedidata Rave, Signant Health, Smart BioClinia, RedCap, as well as Emory’s Portal systems ERMS, SharePoint, Complion, OnCore, Epic.

Create, Report and document SAEs and deviations for PI assessment; resolves study queries. Emory University School of Medicine – Cardiac Device - Electrophysiology, 10/2015 – 7/2021 Clinical Research Coordinator II

Managed multiple studies from large to small trials Phase I – Phase IV according to the study protocol.

Managed data entries for assigned studies involving queries and resolving complex issues.

Organized and attended Investigator/SIV Meetings for study startup.

Reviewed medical records, screened, recruited, consented study participants.

Performed different levels of cognitive assessments on study participants as it pertains to the study.

Ensured IRB submissions and approvals are obtained prior to study initiation and IRB requirements are met.

Managed device accountability logs manually and electronically.

Provided daily oversight on all team studies and provided staff training.

Reconciliated data in study sponsors EDC laboratory data and reported/documented SAE’s.

Effectively communicated with PI/Physicians regarding medical concerns or issues related to study participants.

Lead Coordinator on a study utilizing eConsent Informed Consent Process electronically, and one of the first site to use it.

Performed procedural requirements of the study protocol i.e., lab work, blood pressure, EKGs, Holter monitoring, pulmonary function test, as specified by study protocol.

Scheduled, conducted and documented follow-up visits with subjects.

Supported the Interrogations/Implantation of cardiac devices with Sponsors Field Clinical staff. Emory Healthcare at St. Joseph Internal Medicine Assoc., Atlanta, GA 09/2013 – 9/2015 Certified Medical Assistant

Provide exceptional patient care for a busy internal medical practice. Helped to resolve employee conflicts, managed and initiated back office meetings.

North Atlanta Endocrinology and Diabetes, Lawrenceville, GA 05/2013 – 07/2013 Medical Assistant Externship

Served as an extern student as part of a professional healthcare team for a busy endocrinologist and diabetic practice. Assist six MDs, two NPs, one PA, and a dietician.

EDUCATION/SKILLS: CLINICAL TRIAL PLATFORM/DATABASE: Gwinnett Technical College, Lawrenceville, GA Oracle, iMedidata (Rave), Signant Health, Smart BioClinica,

Assisting Program, CMA (AAMA), 07/ 2013, 2017 Clario, FireCrest, eSource, Recap, Vitalograph, Clintrak,

Clinical Research Program ERMS (Electronic Records Management System), SharePoint, Voorhees College, 08/1984 OnCore, Complion, Epic, Complion, Veeva Vault College of Charleston, 06/1985

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