Donna McLean

Dedicated and patient-focused clinical research professional with 10 years of extensive experience providing support, coordination, and leadership for studies that involve industry and investigator-initiated sponsored Phase I, II, and III clinical trials. Extensive experience as a clinical trial manager, clinical research coordinator, and well-versed in designing study protocols. Excellent problem-solving abilities with a detail-oriented nature.

Ready to bring 10 years of trial experience to a challenging new role.

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