Summary
Overview
Work History
Education
Skills
Certification
Therapeutic Areas
Timeline
Generic

Charvette Patrick

San Antonio,TX

Summary

Dedicated and highly experienced clinical research professional with 18 years of diverse expertise in various roles, including post-operative surgery, human resources, and inpatient unit management. Proven track record in overseeing a 19-bed unit while effectively managing clinical operations and ensuring high standards of patient care. As a project manager, successfully led the build-out of a state-of-the-art surgery center, demonstrating strong leadership and organizational skills. Proficient in clinical research coordination, including contracting and budgeting negotiations, with a focus on optimizing resource allocation and enhancing operational efficiency. Experienced trainer for Advanced Cardiovascular Life Support (ACLS), Basic Life Support (BLS), and protocol adherence, committed to fostering a culture of continuous learning and development. Adept at onboarding new employees, ensuring they are well-prepared to contribute to team success.

Overview

19
19
years of professional experience
1
1
Certification

Work History

Director of Clinical Operation

Evolution Research Group
12.2022 - 05.2025
  • Assists with quality control measures and reviews.
  • Reviews protocol deviations and determines if a Corrective and Preventive Action (CAPA) report is needed which would include identifying the root cause.
  • Works with the sponsor, Site Director, and Principal Investigator to ensure compliance with protocol requirements.
  • Work with Principal Investigator, Site Director, and Recruitment Manager to develop effective programs for study enrollment.
  • Supports the clinical operations team in the planning, implementation, and execution of clinical research studies, from study start-up to close-out, ensuring compliance with protocol requirements, regulatory guidelines, and Good Clinical Practice (GCP) standards.
  • Assists with strategic direction and guidance for the development and execution of clinical trial operational plans, including resource allocation, study timelines, study enrollment, and budget management.
  • Collaborates with cross-functional teams, including clinical development, regulatory affairs, data management, and biostatistics, to ensure seamless integration of clinical operations activities and achievement of study objectives.
  • Supports in the selection, qualification, and management of clinical research sites, investigators, and vendors, ensuring adherence to contractual agreements, performance metrics, and quality standards.
  • Implements risk-based monitoring strategies and oversees monitoring activities to ensure the integrity, quality, and completeness of clinical trial data.
  • Supports the development and implementation of standardized processes, tools, and training programs to optimize clinical trial operations and promote efficiency and consistency across studies.
  • Ensures timely communication and resolution of issues.
  • Monitors industry trends, regulatory updates, and best practices in clinical trial management and implement continuous process improvements to enhance operational efficiency and effectiveness.
  • Mentors, coaches, and develops clinical operations team members, fostering a culture of collaboration, innovation, and professional growth.
  • Supports the Clinical Study Manager with overseeing and coordinating clinical trials at various investigational sites.
  • Manages the mobile teams by the conduction of clinical trials throughout the organization of Evolution Research Group.
  • Supports Project Managers.
  • Oversees the activities of direct reports as delegated.
  • Attends investigator meetings for each assigned protocol, as appropriate.
  • Conducts unannounced site visits to assess audit readiness.
  • Negotiate Contracts and Budgets for Clinical Trials.
  • Reviews protocols for CMS Clinical Trial Policy.
  • Coverage Analysis.
  • Determines the SOC vs. Research.
  • Develops the clinical trial or study budget.
  • Completes company required trainings: Monitoring Visits, Regulatory Documents, IP Accountability, Safety (AEs, SAEs, SUSARs, etc), ICFs, ICH/GCP, GLP.

Senior Analgesic Manager Pain Studies/ Pain Management Research Sites

Evolution Research Group
02.2022 - 12.2022
  • Obtains detailed knowledge of all components of each study protocol through review and analysis of study information with Principal Investigator and Site Director prior to the effective date of the study.
  • Works with Site Director and Principal Investigator to assign a primary clinical research coordinators.
  • Reviews with Principal Investigator and Site Director, any components of the study for which additional information or clarification are required prior to the initiation of the study.
  • Oversees and is responsible for the conduct of all studies managed by his/her direct reports.
  • Develops a quality management plan for each protocol in conjunction with the Site Director and any applicable quality management team members.
  • Assists with quality control measures and reviews.
  • Works with the sponsor, Site Director, and Principal Investigator to ensure compliance with protocol requirements.
  • Negotiates Contracts and Budgets for Clinical Trials. Reviews protocols, CMS Clinical Trial Policy, Coverage Analysis, Determines the SOC vs. Research, and developing the clinical trials or study budget.
  • Collaborates with Principal Investigator, Site Director, and Recruitment Manager to develop effective programs for study enrollment.

In-Patient Director Clinical Research

Endeavor Clinical Trials, LLC
10.2021 - 02.2022
  • Proactively manage project level operational aspects of Clinical Trial Team including management of timeline, project expectations, enrollment, resources, and vendors.
  • Providing access and/or resources for all employees to complete the training needed to perform project responsibilities.
  • Study team assignments will be made in conjunction with site management team. PM will assign, oversee, and assist with study specific task for the assigned team and project.
  • Communicate and hold accountable the role, responsibilities, task assignments, and performance expectations to the clinical staff assigned to the clinical trial.
  • Hold accountable the applicable staff for the successful completion of assigned tasks.
  • Assists with staffing needs, providing back-up study coordinator coverage when needed.
  • Negotiating Contracts and Budgets for Clinical Trials. Reviewing protocols, CMS Clinical Trial Policy, Coverage Analysis, Determining the SOC vs. Research, and developing the clinical trials or study budget.
  • Ensure appropriate study coordinator coverage in conjunction with site leadership across all projects being completed at the site.
  • Provides backup coverage for Site Director, as needed.

In- Patient Director/Administrator -Ambulatory Surgical Center

Endeavor Clinical Trials, LLC
08.2020 - 10.2021
  • Serving as supervisor and mentor to all direct reports as detailed by the organizational chart.
  • Performing and/or overseeing all HR responsibilities for reporting staff including but not limited to performance evaluations, corrective action plans, staff recognition, recruitment and onboarding of new employees, and management of staff schedules.
  • Providing access and/or resources for all employees to complete the training needed to perform job responsibilities.

Research In- Patient Unit Manager, Surgical Team

Endeavor Clinical Trials, LLC
06.2017 - 08.2020
  • Works closely with the Medical Director, Governing Body and the Nursing Supervisor to create and implement the Strategic Plan, Goals and Objectives, communicating to and integrating the Center staff as appropriate.
  • Monitors the training and progress of employees the goals and objectives, initiating the appropriate actions to assure successful completion.
  • Assures the coordination of all meetings as calendared; general staff meetings, Performance Improvement Committee, Medical Executive Committee, Governing Body, annual Medical Staff meeting and all other sub-committees’ meetings as determined to be necessary.
  • Assures consistent use of processes for the identification, reporting, analysis and prevention of surgical adverse events.
  • Assures facility compliance with all licensures, certification and regulatory requirements.
  • Directs and oversees the creation of, and the updating of all surgical policy and procedure manuals.
  • Assures compliance with credentialing standards for all medical/allied health and Nursing staff.
  • Assures the evaluation of patient, physician and staff satisfaction on a regular basis, taking actions as appropriate to address issues and concerns and further assures a timely resolution.
  • Serves as supervisor and mentor to all direct reports as detailed by the organizational chart.
  • Performs and/or oversees all HR responsibilities for reporting staff including but not limited to performance evaluations, corrective action plans, staff recognition, recruitment and onboarding of new employees, and management of staff schedules.
  • Provides access resources for all employees to complete training as needed to perform job responsibilities.

Clinical Research Project Manager/ Research In- Patient Unit Manager

Endeavor Clinical Trials
06.2017 - 08.2020
  • Assists in the design, preparation, planning, implementation, and review of clinical trials.
  • Provides leadership for assessing, planning, implementing and evaluating patient care and safety.
  • Performs accompanied monitoring visits (PSV, SIV, IMV, COV).
  • Conducts review of the Investigator Site File.
  • Assists with remote data review (EDC) to identify trends and issues (particularly AES, CMs, Prohibited Meds).
  • Assists review of Monitoring Visit Report.
  • Completes in-office and WebEx trainings to ensure all aspects of conducting monitoring visits (per ICH/GCP and applicable regulations) are understood and applied.
  • Performs administrative tasks such as completion of invoices, expenses, MVRs, CLs and FU Letters.
  • Negotiates Contracts and Budgets for Clinical Trials. Reviewing protocols, CMS Clinical Trial Policy, Coverage Analysis, Determining the SOC vs. Research, and developing the clinical trials or study budget.
  • Completes company required trainings: Monitoring Visits, Regulatory Documents, Regulatory Agencies, IP Accountability, Safety (AEs, SAEs, SUSARs, etc), ICFs, ICH/GCP, GLP.

Clinical Research Coordinator

Endeavor Clinical Trials
01.2014 - 08.2020
  • Facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.
  • Schedules study participant appointments and serves as the patient liaison to the PI and other participating physicians.
  • Reviews and comprehends each assigned protocol including study proceedings and timelines, inclusion and exclusion criteria, confidentiality and privacy protections.
  • Working closely with the PI, participates in an integral way in the informed consent process by communicating clearly and openly with potential study patients about protocols open to enrollment.
  • Possesses a thorough knowledge of the informed consent process as well as a thorough understanding of the study protocol(s) to be able to answer all questions pertaining to the study posed during the informed consent process.
  • Completes case report forms. Extracts data from patient charts in a timely manner.
  • Responds to data clarification requests in a timely manner.
  • Coordinates with PIs and department to help ensure that clinical research and related activities are performed in accordance with Federal regulations, and sponsoring agency policies and procedures.
  • Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan.
  • Maintains records and other documentation of training.
  • Maintains subject screening logs and protocol deviation logs.
  • Maintains spreadsheet tracking updates to databases of all subjects enrolled on clinical trials.
  • Coordinates and facilitates monitoring and auditing visits. Notifies appropriate institutional officials of external audits by IRB’s, Regulatory agencies, CRO’s and sponsors.
  • Collaborates with PI and institutions to respond to any audit findings and implement-approved recommendations.
  • Ensures that all materials for each clinical trial protocol are available for subject enrollment.
  • Works collaboratively with the other members of the clinical research team and the clinical and administrative support teams to ensure all protocols are followed and that there is timely documentation and submission of study data.
  • Performs specimen processing and shipment of biological specimen duties.
  • Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials as required.
  • May perform other job-related duties as requested or required.

Clinical Research Coordinator

Clinical Trials of Texas
01.2014 - 12.2014
  • Facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.
  • Schedules study participant appointments and serves as the patient liaison to the PI and other participating physicians.
  • Reviews and comprehends each assigned protocol including study proceedings and timelines, inclusion and exclusion criteria, confidentiality and privacy protections.
  • Works closely with the PI, participates in an integral way in the informed consent process by communicating clearly and openly with potential study patients about protocols open to enrollment.
  • Possesses a thorough knowledge of the informed consent process as well as a thorough understanding of the study protocol(s) to be able to answer all questions pertaining to the study posed during the informed consent process.
  • Completes case report forms. Extracts data from patient charts in a timely manner.
  • Responds to data clarification requests in a timely manner.
  • Coordinates with PIs and department to help ensure that clinical research and related activities are performed in accordance with FDA regulations, and sponsoring agency policies and procedures.
  • Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan.
  • Maintains records and other documentation of training.
  • Maintains subject screening logs and protocol deviation logs.
  • Maintains spreadsheet tracking updates to databases of all subjects enrolled on clinical trials.
  • Coordinates and facilitates monitoring and auditing visits. Notifies appropriate institutional officials of external audits by IRB’s, Regulatory agencies, CRO’s and sponsors.
  • Collaborates with PI and institutions to respond to any audit findings and implement-approved recommendations.
  • Ensures that all materials for each clinical trial protocol are available for subject enrollment.
  • Works collaboratively with the other members of the clinical research team and the clinical and administrative support teams to ensure all protocols are followed and that there is timely documentation and submission of study data.

Medical Assistant Lead Instructor

Southern Careers Institute
08.2013 - 01.2015
  • Responsible for Teaching Night Class Medical Assistant Students.
  • Ensure curriculum was followed and responsible for an engaged classroom setting.
  • Lead MA Labs.
  • Responsible for CPR, ACLS, Pals, Accounting and Customer Services.
  • Responsible for creating innovative and creative live medical experiences for class real world experiences.
  • Responsible for coordinating field trips to a variety of medical establishments to help students broaden the best practice fit for their medical career.

Chief Operation Office / Emergency Medical Technician - Paramedic

Impact Urgent Care
01.2010 - 12.2013
  • Responsible for maintaining operational excellence while ensuring that strategic and goals of the company were met.
  • Ensures patients and their families receive value care during their visits to urgent centers.
  • Demonstrates the ability to modify tactics to unique market dynamics while maintaining understanding of urgent care enterprise strategies.
  • Conducts operating reviews, financial/operational/quality focused meetings/calls as needed to properly drive initiatives and strategies that help manage the core business.
  • Optimizes team performance through clear communication, resolution and problem solving, operational accountability, team unity, financial accountability and talent development.
  • Cultivates talent of local leaders to drive local organizational performance and lead to ongoing excellence and effective growth of the business while maintaining the highest integrity.
  • Builds a competitively superior organization by attracting, developing, and retaining talent to ensure that people with the right skills and motivations were in the right places at the right time to meet business needs including performance management and improvement plans.
  • Evaluates organizational efficiency / effectiveness, makes recommendations to organizational and process changes as necessary, and implements recommendations to achieve the goals and objectives.
  • Builds strategic alliances outside the organization to create business opportunities and execute business strategies.
  • Ability to consistently promote and act in a manner that supports the clinic’s mission, vision, and values, instilling the company’s aspiration, and develop leadership across the organization.
  • Assures the clinics are in full compliance with policies, regulations and legal requirements including ethics requirements and expectations.
  • In collaboration with Leadership team provides oversight for center acquisition, divestiture.
  • Strengthens organizational infrastructure and develops leadership pipeline to support future growth.
  • Actively participates in and provides executive-level support for Group and division recruitment and retention activities.
  • Promotes quality of care by ensuring all centers understand and are actively participating in achieving identified quality and service performance metrics.
  • Assists the President in collaborative efforts related to the development, communication and implementation of effective strategies and processes.

Clinical Research Coordinator/Subject Advocate

Cedra Clinical Research (Worldwide Clinical Trials)
01.2006 - 01.2010
  • Handled all issues related to subject relations: Subject Advocacy, conflict management, subject counseling, customer service data collection, in house experience refinement, and subject surveying.
  • Served as the internal voice of study subjects, providing various department managers with subject-derived insights.
  • Conducted customer service training.
  • Chairman for the No contact committee.
  • Supervised PRN staff.
  • Conducted conflict management training to Staff.

Education

Clinical Research Associate, Certificate - undefined

Lotus Academy
San Antonio
01.2023

License Emergency Medical Technician Paramedic (NREMT-P), Associates - undefined

San Antonio College
San Antonio
01.2003

Skills

  • MS Word
  • MS Excel
  • Outlook
  • IVRS
  • CTMS
  • Medidata Rave (EDC)
  • DataLabs (EDC)
  • Express(EDC)
  • Fusion(EDC)
  • LabConnect
  • RealTime (CTMS)
  • Patient recruitment
  • Ethics committee liaison
  • Monitoring oversight
  • Clinical leadership
  • Collaborative skills
  • Effective communication
  • Patient education
  • Patient care coordination
  • Exemplary communication skills
  • Patient relations
  • Staff development
  • Patient relationship management
  • Performance improvement
  • Meeting participation
  • Marketing initiatives
  • Interdisciplinary collaboration
  • Resource coordination
  • Community outreach programs
  • Unit supervision
  • Managing patient cases
  • Care review
  • Unit leadership
  • Organizing staff schedules
  • Medical staff leadership
  • Teamwork
  • Teamwork and collaboration
  • Customer service
  • Problem-solving
  • Time management
  • Attention to detail
  • Problem-solving abilities
  • Multitasking
  • Excellent communication
  • Critical thinking
  • Organizational skills
  • Team collaboration
  • Active listening
  • Verbal and written communication
  • Decision-making
  • Relationship building
  • Training and mentoring
  • Patient education and counseling
  • Employee supervision
  • Team building
  • Task prioritization

Certification

  • Emergency Medical Technician- Paramedic
  • Certified CPR Instructor
  • Certified ACLS Instructor
  • Certified PALS Instructor
  • Certified HIPAA Compliance Officer
  • Good Clinical Practice, Collaborative Institutional Training Initiative
  • IATA
  • CRA LOTUS Academy
  • Ramsey Sedation Scale Rater

Therapeutic Areas

  • Cardiac: (Cardiac Troponin)
  • Device (Continuous Glucose Monitor (CGM), Immunoassay Analyzer, Vaping Pens)
  • Endocrine (Diabetes Mellitus, Diabetic Neuropathic Foot Ulcers, Diabetic Nephropathy, Continuous Glucose Monitor) (CGM)
  • Infectious Disease (COVID)
  • Musculoskeletal (Bunionectomy, Herniorrhaphy, Abdominoplasty, Blepharoplasty, Brachioplasty)
  • Neurological (Smoking Cession)
  • Psychiatric (Depression, Acute Schizophrenia, Bipolar I Disorder, Opioid Addiction)
  • Phase 1 Pharmacokinetics

Timeline

Director of Clinical Operation

Evolution Research Group
12.2022 - 05.2025

Senior Analgesic Manager Pain Studies/ Pain Management Research Sites

Evolution Research Group
02.2022 - 12.2022

In-Patient Director Clinical Research

Endeavor Clinical Trials, LLC
10.2021 - 02.2022

In- Patient Director/Administrator -Ambulatory Surgical Center

Endeavor Clinical Trials, LLC
08.2020 - 10.2021

Research In- Patient Unit Manager, Surgical Team

Endeavor Clinical Trials, LLC
06.2017 - 08.2020

Clinical Research Project Manager/ Research In- Patient Unit Manager

Endeavor Clinical Trials
06.2017 - 08.2020

Clinical Research Coordinator

Endeavor Clinical Trials
01.2014 - 08.2020

Clinical Research Coordinator

Clinical Trials of Texas
01.2014 - 12.2014

Medical Assistant Lead Instructor

Southern Careers Institute
08.2013 - 01.2015

Chief Operation Office / Emergency Medical Technician - Paramedic

Impact Urgent Care
01.2010 - 12.2013

Clinical Research Coordinator/Subject Advocate

Cedra Clinical Research (Worldwide Clinical Trials)
01.2006 - 01.2010

Clinical Research Associate, Certificate - undefined

Lotus Academy

License Emergency Medical Technician Paramedic (NREMT-P), Associates - undefined

San Antonio College

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Charvette Patrick