EXPERIENCE AND EDUCATION | Amanda Carapellucci

PROFESSIONAL EXPERIENCE

Senior Clinical Project Manager

2016 - Present

Responsible for all aspects of multiple Clinical Trial Projects, including site management of clinical trial sites across Canada, to ensure project goals are achieved
Report trial status, metrics and performance to academic partners, stakeholders, trial leadership and CaRE team
Act as the day to day contact and resource for all participating clinical trial sites, academic partners, and monitors as it pertains to the operations of the trial in Canada
Coordinate detailed implementation plans and evaluation strategies for the project
Create and implement quality control processes and ensure study documentation is in line with all regulatory requirements.
Responsible for all regulatory submissions to Health Canada and central ethics board (IRB Services)
Assist in the preparation, review, negotiation and execution of financial contracts for research sites
Assume lead role in evaluating and recruiting research sites through telephone screening interviews and site questionnaires
Supervise data management processes; review data, generate data queries as required and work with sites to ensure clean data is maintained
Develop and maintain project-specific databases to provide project status reports, historical data and fulfill regulatory requirements
Ensure external and internal documentation prepared within the Clinical Operations function is completed in accordance with GCP regulatory requirements and consistent with the protocol.
Responsible for all operational trial communications with regulatory agencies, external partners, monitors and clinical sites to assist in the ongoing monitoring and evaluation of the project and appropriately document all communications
Proactively anticipate potential study issues and prepare contingency plans and/or process improvements

Experience

CVC

Clinical Trials Project Lead

2013 - 2016

Oversee all aspects of multiple Clinical Trial Projects, including site management of 40+ clinical trial sites across Canada, to ensure project goals are achieved
Organize, analyze and communicate Clinical Trials Project information to sites, sponsors and supervisors by creating and distributing newsletters/posters, organizing and executing Canada-wide WebEx based trial updates and training, and via e-mail and phone contacts
Proactively anticipate project issues and develop strategies for resolution to ensure successful project completion
Build and foster relationships with research site personnel by maintaining regular communication via e-mail, phone, and in-person meetings
Provide ongoing guidance and training on trial-specific topics, including protocol adherence, eCRF data management systems, drug supply management systems and essential document completion
Develop, distribute and implement trial-specific forms/work instructions for site use
Manage and coordinate the negotiation of financial contracts and clinical trial agreements
Review and approve country and site-specific Informed Consent documents, in English and French, prior to submission to Health Canada and Research Ethics Boards
Correspond with and build relationships with regulatory agencies, sponsors and external partners to assist in the ongoing monitoring and evaluation of the projects
Identify potential research sites by evaluating site feasibility
Assist with the development, compilation, dissemination, collection, tracking and report generation of regulatory and other essential trial documents according to SOPs and established trial-specific guidelines
Maintain and develop CVC and third-party project-specific databases, including maintaining relevant trial metrics, in order to provide regular updates on project status to team members, trial supervisors and sponsors

WCDI

Clinical Research Coordinator

2011 - 2013

Western Canada Dermatology Clinic/

Youthful Image Research

Initiate and facilitate all clinical monitoring procedures, including pre-study, initiation, monitoring and closeout visits and all associated documentation
Monitor study site independently, according to protocol monitoring guidelines, S.O.P.s, GCP and ICH Guidelines
Full understanding of Adverse Event (AE) and Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of AEs and SAEs.
Prepare applications for ethics submission for approval by Health Research Ethics Board
Screen and enroll study subjects, including completion of screening and consent forms, and case and safety reports
Communicate with research subjects for follow up and to coordinate study visits
Enter and manage data as required and submit research data in a timely manner to external affiliates, sponsors and/or Ethics Review Boards as needed
Analyze and evaluate clinical data including Case Report Forms (CRF) and source documents to ensure subject safety, investigator compliance, and site adherence with study drug protocol, overall clinical objectives, ICH Guidelines, Good Clinical Practice (GCP) and the Personal Health Information Act (PIPA)
Conduct daily aspects of clinical trials/studies according to established study protocols
Provide support and timely follow-up for the implementation of clinical protocols, data collection systems, pre-post audits, quality assurance activities, and final reports
Confer and collaborate with laboratory, pharmacy, and staff in other departments, as per study requirements
Maintain complete and accurate source documentation on all study participants
Ensure complete and thorough study drug accountability and reconciliation
Assist in the preparation of study budgets
Respond to inquiries pertaining to research received from subjects, the public and other healthcare providers
Direct staff recruitment efforts to ensure effective staffing levels for all the entrusted research initiatives