Clinical Operations Leader in Clinical Trials
Resume:
Devin Holland
Clinical Operations Supervisor II
*********@*****.***
Willing to relocate: No
Authorized to work in the US for any employer
Work Experience
Clinical Operations Supervisor
Fortrea- Dallas, TX
June 2024 to Present
Responsible for ensuring that all practical aspects of clinical studies are conducted to the highest possible quality and in accordance with the protocol, SOPs and ICH/GCP standards. Provides leadership, training, coaching, and mentoring for study staff.
Directly supervise staff which may consist of RNs, LVN/LPNs, and Research Technicians
Current knowledge of ICH/GCP standards.
Demonstrate ability to lead by example and to encourage team members to seek solutions.
Ensure that the safety, welfare and dignity of research subjects are not compromised.
Ensure the quality of service provided by team members meets the requirements of both internal and external clients.
Instill in all team members responsible to him/her the Company’s commitment to quality and meeting the client’s requirement and meeting the client’s requirement without error, on time, every time.
Play an active role in the development and implementation of Quality within his. Her area of responsibility.
Assist with the coordination of relevant protocols.
Ensure that all training files are up to date and complete in accordance with SOP’s and ICH/GCP.
Ensure all work in his/her area is carried out in strict accordance with relevant protocols, SOP/s, and in compliance with ICH/GCP.
Supervisor Clinical Research
UT Southwestern Medical Center - Dallas, TX
April 2023 to January 2024
Supervises and coordinates the organization and compliant execution of multiple research projects of a specialized research program with the proper allocation of resources and adherence to research protocol requirements.
Assures quality and safe patient care, anticipating and resolving patient care and study issues by serving as a liaison between investigators, research personnel, outside study personnel and central research administration offices to assist in protocol interpretation, enrollment and safety questions.
Supervises the daily clinical research operations for the research program, fully integrating research protocols with applicable research management systems and processes.
Assists with coordination and implementation of overall research program and associated strategic initiatives.
Participates in process improvement activities.
Participate in strategic planning and operational implementation.
Collaborates with principal investigator, sponsor and research staff to plan, conduct and evaluate project protocols.
Analyzes site strengths and weaknesses related to intended protocol and selection of qualified investigators and sites, if applicable.
Develops and maintains knowledge of research programs and associated protocols to coordinate the comprehensive and compliant execution of protocols.
Assists with preparation for and response to audits.
Monitors and reports on the progress of research projects based upon milestones and contractual payment obligations.
Provides sponsor with individuals’ site forecasting schedules, if applicable.
Works actively with the principal investigator and sponsor, if applicable, in tracking study progress, developing action plans for not meeting contractual deliverables/timelines, and developing a process to review and follow up with action plans that may include possible discontinuing study and/or site termination, if applicable.
Supervises research personnel, ensuring orientation and training, performance management, and career development.
Maintains professional relationships, including frequent and open effective communication with internal and external customers.
Supervises and assists with the development of training and educational material for assigned research protocols.
Provides and documents education as needed.
Supervises and may conduct and document the informed consent process.
May assist PI with research study design and development of research protocol.
Supervises and coordinates research project budget development.
May negotiate industry sponsored research budgets.
Supervises and coordinates research subject recruitment and data management.
Assists with the development, implementation and evaluation of research subject recruitment strategies, including marketing strategies, to maximize enrollment and retention.
Identify, contract, and maintain orders with outside vendors supplying services for the study (e.g., shipping, laboratory services, laboratory supply vendors).
May serve as primary contact for investigators, regardless of funding source, to facilitate research project development, processing and approval routing through the appropriate central research administration offices and systems.
Data Clinical Research Coordinator
UC Davis - Sacramento, CA
July 2021 to Present
Ensure the conduct of the study follows the currently approved protocol/amendment(s), with current GCP guidelines and with applicable regulatory requirements.
Ensure reported data are accurate, complete, and verifiable from source documents. Resolve any discrepancies using a traceable query process.
Verify that Adverse Event reporting is accurate and follows GCP guidelines and applicable regulatory requirements. Escalate any reported Serious Adverse Event in a timely manner.
Document clinical trial progress to ensure completeness of documentation and data collection in adherence with the project timelines.
Ensure collected clinical data is entered in the database in a timely manner, and extract data as required for analysis and reporting purposes.
Keep track of Investigational Product Accountability.
Provide support to the Clinical Management Team.
Conduct training for colleagues or study team as requested.
Fulfill other duties as required.
Clinical Research Coordinator II
Henry Jackson Foundation - San Antonio, TX
September 2020 to July 2021
Coordinated and managed Phase I-III clinical trials for COVID-19 vaccine development.
Recruited, screened, and enrolled eligible study participants in compliance with protocol requirements.
Obtained informed consent and ensured participants’ understanding of study procedures and risks.
Collected, processed, and shipped biological specimens following protocol and regulatory guidelines.
Monitored participants for adverse events and reported findings to the principal investigator and regulatory bodies.
Maintained accurate and timely documentation, including case report forms (CRFs) and electronic data capture (EDC) systems.
Ensured compliance with FDA, IRB, GCP, and other regulatory requirements.
Scheduled and conducted study visits, assessments, and follow-ups per protocol timelines.
Assisted in the development of study protocols, informed consent documents, and other trial-related materials.
Collaborated with multidisciplinary teams, including sponsors, CROs, and regulatory agencies.
Managed investigational product (IP) accountability, including storage, dispensing, and reconciliation.
Participated in site audits, monitoring visits, and regulatory inspections.
Provided patient education regarding study participation, vaccine efficacy, and potential side effects.
Ensured data integrity and quality control throughout the study lifecycle.
Clinical Research Coordinator
QUALITY RESEARCH- San Antonio, TX
March 2019 to October 2020
Health-care professional who works under the direct supervision of a physician investigator and clinical trial associate. Responsible for organizing all aspects of a medical/pharmaceutical research project. Duties include recruiting participants, collecting research data and managing all calendars as they relate to the project.
Certified Nurse Assistant
CHRISTUS HEALTH- San Antonio, TX
January 2018 to February 2019
Assisted patients with Activities of Daily Living; executed acute care plan protocols; aided mobility during patient transports.
Clinical Research Coordinator
Endeavor Clinical Trials- San Antonio, TX
Pain Management, Podiatry, Orthopedics
January 2016 to January 2018
Managed therapeutic research protocols within multiple service lines: Pain Management, Podiatry, Orthopedics, Internal Medicine, Neurology, and Dermatology
Anesthesia Technician
Methodist Children’s Hospital- San Antonio, TX
July 2014 to December 2015
Prepared surgical equipment, managed calibration and inventory records.
Assist anesthesiologists and nurse anesthetists in preparing and administering anesthesia for surgical procedures.
Set up, calibrate, and maintain anesthesia equipment, including ventilators, monitors, and infusion pumps.
Prepare and check anesthesia machines, gas delivery systems, and related supplies before procedures.
Ensure the availability and proper functioning of emergency airway equipment and anesthesia carts.
Assist in the preparation and positioning of patients for anesthesia administration.
Monitor and replenish anesthesia-related medications and supplies, maintaining inventory control.
Sterilize and clean anesthesia equipment according to hospital protocols and infection control guidelines.
Support the anesthesia team during intubation, extubation, and patient resuscitation as needed.
Assist with patient transport and post-anesthesia care unit (PACU) handoffs.
Maintain accurate records of equipment checks, supplies used, and procedures performed.
Adhere to hospital policies, safety standards, and regulatory compliance, including Joint Commission and OSHA requirements.
Participate in training and continuing education to stay updated on anesthesia technology and best practices.
Education
BSN in Nursing
West Coast University- Richardson
Currently enrolled
March 2027
BBA in Healthcare Administration
Texas Woman's University - Denton, TX
December 2022
A.S. in NURSING SCIENCE
St. Phillip’s College
May 2016
Skills
•Clinical Research
•Clinical Trials
•GCP
•Laboratory Experience
•Recruiting
•Research
•Triage
•Microsoft Office
•Vital Signs
•FDA Regulations
•Experience Administering Injections
•Epic
•GLP
•Medical Records
•Employee Orientation
•Microsoft Excel
•Data collection
•Patient Care
•Hospital Experience
•Research & Development
•Calibration
•EMR Systems
•Quality Assurance
•Customer service (10+ years)
•Medication administration
•English
•Medical terminology
•Computer skills
•Patient monitoring
Links
linkedin.com/in/devin-holland-4114735
Certifications and Licenses
CNA
CPR Certification
AED Certification
BLS Certification
State Tested Nursing Assistant
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