Dianna McLean-Leroux
Brossard,QC
Summary
Dynamic leader with over 7 years of clinical research experience, notably at RI-MUHC, where I excelled in trial oversight and workforce training. Skilled in both critical thinking and team building, I have a proven track record of enhancing study compliance and mentoring teams to achieve excellence in clinical operations.
Overview
14
14
years of professional experience
Work History
Supervisor Clinical Research - Oncology
RI-MUHC
Montreal, QC
01.2019 - Current
- Supervise the day-to-day clinical Trial management, Clinical operations and administration.
- Worked closely with all the parties involved to ensure successful studies inspections;
- Managerial tasks, Financial aspects, Regulatory aspects and Business development leads;
- Project management and Clinical Trial Operations Phase I- Phase 3.
- Mentored employees, consultants and students on how to run a sussessful clinical reserach trial.
- Assist with activities related to study participant screening, recruitment, study conduct, and regulatory adherence;
- Explain study procedures and accurately obtain informed consent from participants;
- Contribute expertise to study reports, regulatory documents.
- Plan and implement resourcing strategy for project and study team, work across boundaries to meet program deliverable and timelines;
- Assist in all phases of the studies and trials.
- Work with outside specialists, Investigators and sponsors.
- Supervise logistics requirements of clinical for smooth conduct of studies;
- Manages multiple projects at a time, serve as a resource person for the clinical staff and all parties involved in the study performance;
- Tracking the invoices and ensure they follow the milestones
- Supervise all aspects of the study progress
- Ensuring trials are conducted, recorded and reported according to the study protocol, SOPs/GCP/Regulatory requirements;
- Monitor clinical data, quality and progress of trials for complete compliance according to the regulatory requirements
- Organize and conduct pre-study site selection in term of feasibility of study.
- Planning the project to achieve the required results within required constraints such as time limit, effective cost and desired quality standards;
- Literature review for the study design and budget;
- Monitor clinical activities to ensure the data is collected and recorded properly, the pharmacovigilance forms are completed and available instantly for the investigator’s review and the regulatory agencies as needed;
- Assist the Responsible of Human resources in selecting qualified staff in respect of ICH guidelines;
- Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.
- Worked successfully with diverse group of coworkers to accomplish goals and address issues related all phases of clinical research.
- Demonstrated leadership by making improvements to work processes and helping to train others.
- Prioritized and organized tasks to efficiently accomplish goals.
Medical Repatriation
Repatriation Solutions
Montreal, QC
01.2012 - Current
- Medical Escort for Medical for medical repatriation (On call basis)
- Promoted high customer satisfaction by resolving problems with knowledgeable and friendly service.
- Understood and followed oral and written directions.
- Adjusted therapies during transport to respond to changes in patient outcomes.
- Delivered high level of care to each and every patient from initial contact until delivery to receiving hospital.
- Assessed patients immediately to determine best facilities for transport.
- Evaluated patients throughout aircraft transports to trauma centers for treatment.
- Responded to emergency situations with speed, expertise and level-headed approaches to provide optimal care, support and life-saving interventions.
- Administered oral, IV and intra-muscular medications and monitored patient reactions.
- Coordinated with healthcare team to establish, enact and evaluate patient care plans.
Clinical Research Coordinator
Center for Innovative Medicine, McGill University Health
01.2017 - 01.2018
- Specialization: Breast, Head and neck, Genitourinary, Melanoma, Radiation Oncology Phase 1-IV
- Recruits research participants; prescreens all patients prior to getting informed consent
- Assesses patients for Protocol eligibility
- Maintains, completes and updates all concomitant and adverse events logs and questionnaires and protocol specific source documentation
- Completes all patient charting
- Informs Investigator and pharmacy and sponsor of all important patient information
- Coordinates all protocol related test including sample collection
- Processes and ships all samples according to protocol and manual
- Ensures patients medication compliance
- Prepares orders for protocol related request and procedures
- Conducts patient survival calls
- Attends all SIV and Investigator meetings
- Attends all disease site meeting ( Tumor Board)
- Completes all data entry for all study patients
- Help with all ethics board submissions and ensures ethical approval throughout the study
- Conduct all visits with the Monitor to ensure that data is clean and submitted
- Participate in all Audits and Inspections regarding protocol
- Meet with new sponsors regarding study protocols
- Identify all slides and blocks sent to central vendor
- Oversees all protocol related procedures
- Participate and maintain continuing education ( Attend all conferences continuing education seminars)
Surgical Oncology Coordinator
VM Medical Center, CDL
Rockland
01.2014 - 01.2017
- Arrange and book all surgical procedures
- Arrange all surgical pathology
- Communicate with patients regarding Surgical information and Fee’s
- Arrange staging for patients (CT scan, Bone Scan and pre-op blood work)
- Arrange and book all procedures pre-op (Wire-loc, Sentinel node Biopsy)
- Setting up charts for doctors prior to surgery
- Confirming all appointments with patients
- Coordinating with doctors regarding schedules for surgical interventions
- Help patients navigate from being diagnosed to surgery to post- op care
- Work closely with plastic surgeons in order to give the patient the best possible esthetic outcome
- Assist surgeon with all procedures ( Biopsy, FNA, surgical excisions, Minor procedures )
- Obtains all vital signs for patients
- Identify all slides and biopsies to be sent to pathology
- Tumor Board
- Arrange all cases that will be presented at our weekly tumor board
- Research all pathology
- Communicate with hospitals / suppliers to acquire and then prepare slides
- Organize catering services
- Ensure that VMOP letters are prepared (put into template)
- Invoicing for catering services
- Send out requested charts to various Hospitals or departments in regards to patient’s treatment plan
- Dictate all Tumor board notes and recommendations
- Complete chart review on all patients being presented at tumor board
- Prepare all tumor Board notes
- Manage, , St- Mary’s Hospital Coordination:
- Weekly: Overseeing registration, results, and setting up payment
- Monthly: Invoice for CDL and Rockland, Path qc
- Ordering Supplies
- Manage Path QC / St-Mary’s pathology / lab
- Weekly: Tracking sheets
- Monthly: Invoices
- Results
- Coordinate all Circulating Tumor blood testing for patients
- OncoDX:
- Coordinate entire OncoDX process
- Radiation Oncology clinic and Medical Oncology clinic
- Setting up charts for Radiotherapy Clinic
- Confirming all appointments with patients
- Coordinating with doctors regarding schedules for Radiation oncology and Medical oncology clinic
- Coordinate with NCBC in regards to the International delegate program
- Special: Organize all CME and non CME conference, managing tickets, coordinating with Venue, printing, audio visual and attendees
- Working closely with Medical Director and Director in regards to set up for conferences.
Skills
- 7 Years of Clinical Research Experience
- Supervision & Leadership
- Trial Oversight
- Critical Thinking
- Team Building
- Training & Development
- Planning & Organizing
- Workforce Training
- Work Flow Planning
- Staff Management
- Quality Assurance
- Detail Oriented
- Staff Training and Mentoring
Languages
English
Native/ Bilingual
French
Native/ Bilingual
Timeline
Supervisor Clinical Research - Oncology
RI-MUHC
01.2019 - Current
Clinical Research Coordinator
Center for Innovative Medicine, McGill University Health
01.2017 - 01.2018
Surgical Oncology Coordinator
VM Medical Center, CDL
01.2014 - 01.2017
Medical Repatriation
Repatriation Solutions
01.2012 - Current
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