Donna McLean
Gulf Breeze,Florida
Summary
Dedicated and patient-focused clinical research professional with 8+ years of extensive experience providing support, coordination, and leadership for studies that involve Investigator-initiated and industry sponsored Phase I, II, and III clinical trials. Focused Clinical Research Coordinator well-versed in study protocols, standard operating procedures and general trial oversight. Excellent problem-solving abilities with a detail-oriented nature. Ready to bring 8+ years of related experience to a challenging new role.
Overview
8
8
years of professional experience
Work History
Board Member
University Of Windsor
Windsor, ON
02.2020 - Current
- 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 the University of Windsor student body and local Windsor research canters
- Application of provincial and federal policies governing the use of human subjects in research
- Ensure adherence to Tri-Council Policy Ethical Conduct for Research Involving Humans
- Development of guidance document for the 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
06.2022 - 06.2023
- 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
06.2022 - 05.2023
- Created the 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 the data cleaning plan for all assigned trials
- Updated the data cleaning plan as necessary during trial conduct for all assigned trials
- Executed all DSS processes involved in the locking of the 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
09.2020 - 05.2022
- 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 providers to perform home health care visits
- Maintenance of adequate inventory of study site kit supplies, personal protective equipment, and phlebotomy kits
- Scheduling of home health care visits by sponsor-approved home health care provider
- Development and execution of CDAs, MSAs, and SOWs for multiple nurse agencies across the United States.
- Data reconciliation and input. Responsible for data to reflect accurate and time-sensitive records of AES, SAEs, and other visit details into sponsor-approved database
- Strong, intricate communication with multiple departments required for the clinical trial process, including but not limited to, nurses, study coordinators, clinical research associates, PIs, and participants
- Successful execution of home health care visits all over the United States
Research Lead
Windsor Clinical Research Inc.
Windsor, Ontario
02.2018 - 07.2020
- Completion of multiple research tasks, including but not limited to, systematic literature review, collection, and analysis of both qualitative and quantitative sets of data, conduction of focus group testing, and collaboration with both patient representatives and expert dermatologists internationally.
- Execution and development of research study protocol for clinical randomized controlled trial and ensuring adherence to protocol as set by CONSORT
- Led team to ensure projects were completed within pre-determined timelines, as set by sponsor
- Presentation of research at (3) international conventions of both nursing and dermatology.
- Statistical analyses of both qualitative and quantitative data sets.
- Development and integration of patient-cantered treatment tools for Hidradenitis Suppurativa
- Development and conduction of a randomized controlled trial of a patient decision aid for Hidradenitis Suppurativa.
- Made executive decisions for final project edits.
- Publication of manuscripts in the Journal of the American Academy of Dermatology International, Journal of the American Academy of Dermatology, and Dermatology Online Journal.
- Collaborated with team members to achieve target results.
- Maintained energy and enthusiasm in fast-paced environment.
- Drove operational improvements which resulted in savings and improved profit margins.
- Resolved problems, improved operations and provided exceptional service.
Education
Bachelor of Arts - Psychology
The University of West Florida
Pensacola, FL05.2017
Associate of Science - Nursing
Pensacola State College
Pensacola, FL05.2013
Skills
- Strong understanding of process analysis and management
- Thorough regulatory knowledge of FDA, ICH, and GCP regulations and guidelines
- Extensive project development and management
- Excellent interpersonal and communication skills
- Complete work with high degree of proficiency and autonomy
- Substantial data management experience
- Research Protocol Development
- Data Collections
- Patient Safety
- Documentation Requirements
- Clinical Research Monitoring
- Study Coordination
- Study Management
- Trial Oversight
- SOP Creation
- Adverse Event Documentation
- Laboratory Results Management
Accomplishments
- Development of a hidradenitis suppurativa patient decision aid – PI: Jerry Tan MD, Donna McLean, and Olivia McBride
- Impact of a hidradenitis suppurativa patient decision aid on treatment decision making: A randomized controlled trial – PI: Jerry Tan MD, Donna McLean, and Olivia McBride
- Focus Group Evaluation, Health Care Provider Assessment, and Randomized Controlled Trial of a Patient Decision Aid for Randomized Controlled Trial of a Patient Decision Aid for Hidradenitis Suppurativa Hidradenitis Suppurativa- PI: Jerry Tan MD, Donna McLean, Olivia McBride
- A PHASE 1, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, TRIAL USING CANNABIDIOL FOR THE TREATMENT OF DIABETIC PERIPHERAL NEUROPATHY OF THE FEET- PI: Debra Kimless, MD, Donna McLean, Stephen Goldner
Timeline
Senior Clinical Research Coordinator
Curebase
06.2022 - 06.2023
Clinical Trial Manager
Pure Green Pharmaceuticals
06.2022 - 05.2023
Senior Clinical Research Coordinator
Marken
09.2020 - 05.2022
Board Member
University Of Windsor
02.2020 - Current
Research Lead
Windsor Clinical Research Inc.
02.2018 - 07.2020
Bachelor of Arts - Psychology
The University of West Florida
Associate of Science - Nursing
Pensacola State College
Similar Profiles
Salvatore VeltriSalvatore Veltri
Mock Trial Lawyer at University of WindsorMock Trial Lawyer at University of Windsor
Zarin TasnimZarin Tasnim
Graduate Teaching Assistant at University of WindsorGraduate Teaching Assistant at University of Windsor
Salman Ahmed KhanSalman Ahmed Khan
Graduate Student Assistant at University of WindsorGraduate Student Assistant at University of Windsor
Ismat Ara KhanIsmat Ara Khan
Graduate Teaching Assistant at University of WindsorGraduate Teaching Assistant at University of Windsor
Todd WilliamsTodd Williams
Landscape Architect at SelfLandscape Architect at Self