MISTY RA-AMARI

Work History

SENIOR CLINICAL RESEARCH ASSOCIATE

Altruist Ltd

Houston, TX

05.2020 - Current

Support, manage and execute projects to ensure the clinical trials are conducted, recorded, and reported per the protocol, federal regulations, and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research.
Participates in the study startup and site opening activities, study conduct, and site closure tasks.
Manages the activities of clinical investigative sites across multiple protocols and different therapeutic areas.
Ensure quality and timely data submission from study sites, including appropriate reporting and follow-up for all safety events by site personnel.
Ensure the safety and protection of study subjects.
Support and conduct site qualification, initiation, interim monitoring, and study closeout visits for Phase 1-4 studies following local regulations, Good Clinical Practices (GCPs), ICH Guidelines, Standard Operating Procedures (SOPs), and business processes, if applicable.
Manage the activities of clinical investigative sites across multiple protocols and multiple therapeutic areas.
Train study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members.
Appropriately escalates serious or outstanding issues.
Facilitate Quality Assurance Audit processes as indicated.
Ensure regulatory inspection readiness at assigned clinical sites.
Report monitoring activities and study site conduct wholly and accurately.
Prepare and submit written reports, both monitoring and administrative, to inform management of study progress through periodic updates.
Supports Clinical Trial Application submissions and remote monitoring, including relevant, informed consent local changes and translations into the local language as required.
Obtain and prepare regulatory/essential documents throughout the duration of a study including, but not limited to, FDA 1572, CVs, professional licensure, financial disclosure forms and IRB submission forms.
Implemented electronic data capturing systems to adhere with clinical research guidelines.
Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
Collected, evaluated, and modeled collected data.
Demonstrated leadership skills in managing projects from concept to completion.

CLINICAL RESEARCH ASSOCIATE II

Altruist Ltd

Houston, TX

07.2017 - 05.2020

Assisted with the development and implementation of study-specific monitoring and reporting procedures, methods, guidelines, and tools; participates in the establishment of baseline parameters and edit check specifications, and in the development of subject tracking systems.
Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
Conducted clinical trial in accordance with protocol and recorded and monitored progress.
Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity.
Maintained an inspection ready TMF for a GCP inspection.
Oversaw project developments to provide quality deliverables while maintaining optimal efficiency.
Traveled to investigative sites to conduct site qualification, initiation, interim monitoring, and close-out visits to maintain and enforce regulatory compliance.
Followed drug storage procedures to comply with protocols and SOP requirements.
Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents, and data completion.
Set up and disbanded trial study centers to manage clinical study activities for 125 sites.

CLINICAL RESEARCH ASSOCIATE I

Worldwide Clinical Trials

Houston, TX

06.2015 - 07.2017

Ensured protection of study subjects by verifying that informed consent procedures have been followed and protocol requirements are adhered to according to applicable regulatory requirements.
Monitored safety of human subjects and oversaw consent procedures to comply with local and federal regulations.
Gathered and organized clinical trial documentation to meet rigorous standards for site approval.
Monitored, tracked, and followed up on all Adverse Events (AEs) and Serious Adverse Events (SAEs).
Ensured all SAEs are reported to sponsor and regulatory authorities within required timelines.
Ensured accuracy and integrity of data submitted on electronic or paper Case Report Forms (CRFs) or other data collection tools by comprehensive source document review.
Monitored data for missing or discrepant data.
Ensured all required monitoring tasks are conducted according to SOPs, established guidelines, work instructions (WIs), monitoring plans, and project plans.
Conducted eCRF/CRF review, query generation, and resolution against established data review guidelines.
Assisted with feasibility collection and general collection of investigator regulatory documents.
Created spreadsheets or other tracking tools used to update and track study milestones and progress.
Compile and prepare clinical trial information for IRB reporting and submission.

CLINICAL RESEARCH COORDINATOR

DaVita Clinical Research

Houston, TX

01.2014 - 01.2015

Performed QA/QC procedures, worksheets and study materials, collected data and ordered supplies.
Updated medical records, maintained information on protocol and case reports for each trial, developed flow sheets and identified subject eligibility.
Prepared sponsor files for FDA compliance and GCP guidelines
Conducted Informed Consent of all study participants in conjunction with other team members.
Conducted day-to-day execution of clinical research protocols including obtaining informed consent, completing study procedures, and dispensing, accounting for study drug, and documenting drug compliance.
Prepared and distributed medications as per each protocol in conjunction with other team members.
Maintained accurate source documentation as related to all research procedures.
Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
Collected data and followed research protocols, operations manuals and case report form requirements.
Hired and trained over 570 research subjects and monitored progress, answered questions and provided guidance during course of clinical study.

REGULATORY AFFAIRS SPECIALIST

Alpha Impact Rx

Houston, TX

10.2012 - 01.2014

Assisted with assembly, distribution, storage, tracking and retrieval of information pertinent to the regulatory process, including the regulatory submissions process.
Authored and published electronic submissions.
Responded to requests from foreign governments and/or distributors to prepare and submit documentation for marketing approval as well as provide routine regulatory information to associates and affiliates.
Assisted with research, analysis, and communication of information pertaining to the appropriate regulatory pathway for new or modified products.
Provided regulatory direction to development project teams as a core team member; develops regulatory strategy for new products.
Evaluated risk of proposed regulatory strategies and offers solutions.
Reviewed proposed labeling for compliance with applicable US and international regulations.
Wrote, managed, and approved the development of package inserts reviews, evaluations, and approves promotion and advertising material for compliance with applicable regulations.
Reviewed proposed product changes for impact on regulatory status of the product.
Interpreted and applied FDA regulations to business practices and provides regulatory input, advice, and guidance to the organization and design teams follows company regulatory affairs policy and procedures.

Summary

Overview

Work History

SENIOR CLINICAL RESEARCH ASSOCIATE

CLINICAL RESEARCH ASSOCIATE II

CLINICAL RESEARCH ASSOCIATE I

CLINICAL RESEARCH COORDINATOR

REGULATORY AFFAIRS SPECIALIST

Education

Paralegal Certificate, Advance Paralegal Studies -

Bachelor of Arts - General Business

Skills

Certification

Affiliations

Timeline

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