Clinical Research Project Management
Resume:
Tracy Lynn Jones
Lapeer, Michigan **446 810-***-**** **********@*****.***
Methodical Certified Clinical Research Professional with 19+ years of experience facilitating complex phase I to IV clinical trials. Meticulous medical professional. Ability to adhere to study protocols and laboratory procedures, while developing concise reports to progress studies. Excellent communication skills for team collaboration, leadership, and training. A broad range of knowledge in many therapeutic areas. Experience with Electronic Data Capture (EDC), Electronic Medical Records (EMR), Interactive Voice Recognition (IVR), and Interactive Web Recognition (IWR) systems. Specialized in regulatory management and team leadership. AREAS OF EXPERTISE
GCP/GLP/GDP
Reporting
Leadership
Site Management
Software Management
Regulatory Specialist
Data Reconciliation
ALCOAC Compliance
Study Start-Up
Mapping study progress
TECHNICAL PROFICIENCIES
EDC: InForm, Medidata, RAVE, Medrio, Oracle, DataLabs, many others IVR/ IWR: ClinPhone, Almac, Perceptive, TriaLine, Bracket, Icophone, Cenduit, Clintrak, Everest EMR:
Safety:
Other:
GLO, A-4, Avamark, Meditouch, Greenway, Advanced MD, Athena, Epic SIS, SIR, CTP, Vigilance
Microsoft Excel, Word, PowerPoint, Covance e-site, STEMS, EDX/ EPX, ERT PROFESSIONAL EXPERIENCE
PROJECT MANAGEMENT SPECIALIST Elligo Health Research 2021 to 2024 Perform quality control assessments on sites conducting study protocols throughout the trial to maintain the standards expected. Contribute to the recruitment abilities of research sites using deliberate marketing, RootHealth and other campaigns. Serve as a point of contact when multiple units are assigned the same protocol to ensure team actions remain in synergy. Point of contact for sponsor to site relations. Conduct SIV’s for Elligo sites conducting decentralized trials.
• Member of IntElligo steering committee, our e-source application.
• Review and maintain ISF for accuracy and currency at all decentralized sites.
• Manage Phase II-IV trials from qualification visit to close out visit duties.
• Monitor CFR and IRB compliance on all studies conducted at decentralized sites.
• Determine the operational practices of sites, ensuring each run smoothly, complies with marketing and sales campaigns, and meets budget and sales goals.
• Direct sole management of laboratory specimen services for 30 sites, which entails reconciliation between sites, patients, and the lab when specimens arrive with missing information.
• Hold regular meetings with study managers to ensure understanding and implementation of current studies.
• Work closely with Project Management to maintain sponsor expectations on each study. STUDY MANAGER/REGIONAL OPS MANAGER Elligo Health Research 2017 to 2021 Startup of new-to-research clinics. Orienting physicians and staff to Elligo’s model. Provide the infrastructure, technology and expertise needed to offer clinical research as a care option. Integrate with clinic workflow and manage details from staff hiring and training to study recruitment and enrollment. Guide the study process while protecting the integrity of patients’ data from collection to submission. Page 2 of 3
• Contribute to the recruitment of qualified subjects through deliberate marketing, chart assessments and prescreening.
• Create Source Documents specific to study protocol requirements.
• Maintain required records, such as regulatory documents, protocol changes, review board approvals, and staff training according to CFR and GCP.
• Manage Phase II-IV trials from qualification visit to close out visit duties.
• Ensure CFR and IRB compliance on all studies conducted at site.
• Data collection/data entry/query resolution.
• Correspondence with study teams, CRO, Sponsor.
• Oversee multiple research sites in various therapeutic areas.
• Determine the operational practices of sites, ensuring each run smoothly, complies with marketing and sales campaigns, and meets budget and sales goals.
CERTIFIED CLINICAL RESEARCH COORDINATOR Clinical Research Institute of Michigan 2013 to 2017 Oversee comprehensive research studies with a focus on regulatory affairs. Adhere to strict protocols related to all aspects of conducting clinical research. Implement training to develop competencies of study coordinators. Formalize research practices by creating standard clinical project documents, site operations manuals, spreadsheets, etc. Follow Department of Transportation (DOT), International Air Transport Association (IATA)certification requirements, while conducting laboratory activities.
• Contribute to the recruitment of qualified subjects through deliberate marketing, chart assessments and prescreening.
• Complete CRF’s/eCRF’s.
• Utilize communication skills to effectively interact with investigators, clinical research associates (CRA) and subjects.
• Create Source Documents specific to study protocol requirements.
• Conduct all aspects of research subject visits according to protocol.
• Maintain required records, such as regulatory documents, protocol changes, review board approvals, and staff training according to CFR and GCP.
• Support the gastrointestinal practice and research departments, using Phlebotomy training to meet varying requirements.
• Conduct phase II-IV clinical studies according to sponsor specific protocol and GCP compliance.
• Manage Phase II-IV trials from qualification visit to close out visit duties.
• Ensure CFR and IRB compliance on all studies conducted at site.
• Supports CTM/CRA in the management of investigational site staff to ensure compliance with the trial protocol, ICH/GCP and applicable regulations.
• Maintain Investigational Product accountability for all studies conducted at site. CERTIFIED CLINICAL RESEARCH COORDINATOR Troy Gastroenterology Research Department 2006 to 2013 Implemented complex clinical research initiatives and analyzed all aspects of research to enforce protocols. Accurately entered data obtained during data collection processes in Electronic Case Report Forms (eCRF) and Case Report Forms
(CRF). Monitored and managed laboratory equipment. Complied with Department of Transportation (DOT), International Air Transport Association (IATA), and HAZMAT regulations.
• Developed budgets and negotiated contracts to secure pharmaceutical partners for research projects.
• Fulfilled additional responsibilities to assist nurses, manage equipment, and maintain supplies.
• Evaluated and onboarded clinical trial participants, while following established protocols.
• Initiated quality assurance audits to discover inconsistencies and maintain compliance.
• Presented significant details to study sponsors, internal review boards, and investigators.
• Conduct phase II-IV clinical studies according to sponsor specific protocol and GCP compliance.
• Manage Phase II-IV trials from qualification visit to close out visit duties.
• Ensure CFR and IRB compliance on all studies conducted at site. Page 3 of 3
• Utilize communication skills to effectively interact with investigators, clinical research associates (CRA) and subjects.
EDUCATION & CERTIFICATES
Anatomy, Physiology and Microbiology Coursework
Macomb County Community College, Clinton Township, Michigan Certified Phlebotomist
Certified Clinical Research Professional
The Society of Clinical Research Associates (SOCRA) Basic Life Support (BLS) Cardio-Pulmonary Resuscitation (CPR) Automated External Defibrillators (AED) Good Clinical Practice (GCP) Certifications
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