Clinical Trial Manager - Healix Infusions, Inc - Remote, TX
(2025-04 - 2025-11)
Manage all operational aspects of clinical trials for the remote and on-site staff, including study start-up, daily operations, and study close-out
- Coordinate with Principal Investigator and site staff to ensure clinical activities are performed in accordance with local and federal regulations
- Organize and lead weekly meetings with clinical trial (on-site and remote) staff for each clinical trial
- Develop documentation and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to protocol requirements, visit schedule, and execution of research plan
- Oversee data management of all studies and data capture (EDC) systems (Veeva, Medidata)
- Create and maintain source documentation, as well as ensure necessary medical records and laboratory data are completed and/or reviewed for the study
- Provide documentation and support for study billing activities
- Ensure prompt and complete reporting of adverse events (AEs) and serious adverse events (SAE)
- Organize and maintain all research protocols, electronic ISF and subject data logs for needed access for remote and onsite staff
- Oversee negotiations of new studies- including budget and clinical trial agreements
Project Coordinator - Decentralized Trials and Research Alliance (DTRA) - Remote, CA
(2023-08 - 2025-01)
- Conducted qualitative analyses for DTRA initiatives
- Provided support for DTRA secretariat and executive tasks
- Assisted in creating and disseminating site-adoption tools
- Managed DTRA library
- Assisted in writing and editing proposals for funding to support institutional educational, training, infrastructure, and research efforts
- Proof-read and edited technical and non-technical documents including but not limited to grant proposals, contracts, manuscripts, and presentations
Clinical Research Specialist (IIR) - Arthrex - Naples, FL
(2023-08 - 2024-02)
- Provided clinical data needed for regulatory submissions, publication, and supporting clinical site coordinators
- Managed Investigator-Initiated clinical research studies
- Evaluated and analyzed clinical data
- Collaborated with key opinion leaders to identify issues or barriers related to the research request execution
- Track and report on the progress of assigned clinical studies, including budget and timelines
- Demonstrated excellent organizational, decision-making, and time management skills in a fast-paced environment. Built and maintained excellent working relationships with clinical site staff, key opinion leaders and colleagues
- Lead clinical budget negotiations for the purpose of executing a clinical study
- Showed initiative to identify and implement ways to improve jobs and surroundings through department leadership
Review Ethics Board Member - University Of Windsor - Windsor, ON
(2020-02)
Recipient of Research Excellence Award (2021)
- Voting member of Review Ethics Board
- Attendee of all meetings- both virtual and in-person
- In-depth review of research proposals from both University of Windsor student body and local Windsor research canters
- Application of provincial and federal policies governing use of human subjects in research
- Ensure adherence to Tri-Council Policy Ethical Conduct for Research Involving Humans
- Development of guidance document for resumption of in-person, face-to-face research for Phase 3 trials during global pandemic
- Participation and development of research ethics during COVID-19 pandemic through multi-site collaboration of multiple REBs within Ontario
Senior Clinical Research Coordinator - Curebase - Remote, CA
(2022-06 - 2023-06)
- Conduct patient education, adverse event assessment at designated time-points, and protocol consenting
- Screened patient records, databases and physician referrals to identify prospective candidates for research studies
- Collected data and followed research protocols, operations manuals and case report form requirements
- Coordinated clinical trials focused on disorders such as Cancer and Depression
- Collected, evaluated and modeled collected data
- Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols
- Resolved problems, improved operations and provided exceptional service
- Carried out day-to-day duties accurately and efficiently
- Demonstrated respect, friendliness and willingness to help wherever needed
Clinical Trial Manager - Pure Green Pharmaceuticals - Remote, MI
(2022-06 - 2023-05)
- Created clinical technology design specifications (e.g., EDC, IRT, ePRO) for all assigned trials
- Outstanding experience in clinical development and trials in healthcare and pharmaceutical industry
- Deep knowledge of MS office applications
- Ability to identify and resolve project issues
- Created data cleaning plan for all assigned trials
- Updated data cleaning plan as necessary during trial conduct for all assigned trials
- Executed all DSS processes involved in locking of trial database for assigned trials
- Provide ongoing case management to patients to implement appropriate treatment plan, adhere to quality models and maximize utilization of services needed to achieve optimal outcomes
- Promoted high morale and staff retention through dynamic communication, prompt problem resolution, proactive supervisory practices and facilitation of positive work environment
- Communicated effectively with staff members, physicians and patients, employing active listening and interpersonal skills
- Oversaw overall operation of nursing services and patient care
- Delegated tasks to staff members, monitored completion of all duties and provided support to enhance performance
- Handled job duties for staff members which were unavailable or out of office
- Developed, implemented, revised and evaluated policies and procedures
- Maintained clinic's records and files, utilizing proper techniques to keep patient data confidential
- Implemented onboarding for new employees, which enabled each to effectively learn tasks and job duties
Senior Clinical Research Coordinator - Marken - Remote, NC
(2020-09 - 2022-05)
- Collected data and followed research protocols, operations manuals and case report form requirements
- Gathered, processed and shipped lab specimens
- Coordinated clinical trials focused on disorders such as Virology and Infectious Disease
- Collected, evaluated and modeled collected data
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols
- Maintained compliance with protocols covering patient care and clinical trial operations
- Identified issues, analyzed information and provided solutions to problems
- Participated in continuous improvement by generating suggestions, engaging in problem-solving activities to support teamwork
- Created plans and communicated deadlines to complete projects on time
- Participated in team-building activities to enhance working relationships
- Led projects and analyzed data to identify opportunities for improvement
- Coordination with principal investigator (PI) and site staff to ensure clinical research and related activities are performed in accordance with both state and federal regulations
- Development of Standard Operating Procedures (SOPs)
- Completion of study special projects
- Creation and establishment of study files, including but not limited to, study start-up rate cards, study- specific documentation, patient health information (PHI), and patient source documentation
- Identification, screenings, and approvals of home health care pro
