
Timeline
About me
Clinical Research Associate II at PSI CRO AG
Education

University of sydney
2010 - 2012Bachelor of medical science physiology and cell pathology
Cherrybrook technology high school
2004 - 2009Atar 95.45Activities and Societies: Peer Tutoring
Experience

Woolworths limited
Jul 2007 - Oct 2013Customer service supervisor- Providing customers with friendly and efficient service.- Managing service cashiers: meal break organisation, job designation, appropriate attire and behavior, and queries on the job.- Cash handling: counting all register float at the end of the day to ensure the register is balanced and filing reports when it isn’t.- Register transactions: processing of cheques, EFT and cash transactions.- Answering customer queries and complaints in a courteous manner.- Working cooperatively in a team environment: Designating jobs to staff members so as to complete the closing requirements efficiently.- Resolving unexpected roster changes.- Coordinate the opening and closing of the store Show less

Inc research
Nov 2013 - Sept 2015Project specialist iProject Administration:- Attends Quick Start camps, Quality Finish Camps, process reviews, Kick-Off Meetings and other project meetings as required. - Participates in Trial Master File audits.- Assists in preparation for and attends investigator meetings. - Prepares and maintains Study Reference Manual and site reference tools. Drafts and prepares documents for mass dissemination. - Arranges for receipt of administrative and regulatory documents. - Coordinates the packaging, shipping, and tracking of study supplies and materials.- Transcribes accurate meeting minutes and action items to meet the specifications of the project team and Sponsor.Reporting:-Assists project team with compliance or maintenance of regulatory standards, Standard Operating Procedures (SOPs), and Work Instructions (WI). -Maintains current regulatory documentation according to Essential Regulatory Document Guidelines and TMF Plan. Reviews and submits Essential Regulatory Documents for second review. -Prepares and disseminates Investigator regulatory binder.Communication:- Maintains timely and effective communication among team members and site staff. -Keeps Project Leadership and Clinical Research Associates (CRAs) fully appraised of sites and study status. -Contact site staff as needed for critical information. Show less
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Syneos health (previously inc research/inventiv health)
Oct 2015 - Jun 2018Project specialist iiProject Administration:- Utilizes designated clinical trial management system to track and process clinical trial information in order to provide analysis of information to PM.- Processes and tracks vendor invoices, site invoices, and investigator grants payments on assigned projects.- Supports assigned PM with initiating requests to Finance Department to generate customer invoices for project labor and expenses.- Oversees regulatory documentation according to Essential Regulatory Document Guidelines and Trial Master File (TMF) Plan. Conducts secondary review of Essential Regulatory Documents. Serves as project representative for internal and external TMF audits.- Assists the PM with projection and validation of financial backlog and project realization on assigned projects. Includes review of regular financial reports and analysis of upcoming project events to verify financial forecasts.Reporting:- Records the status of Key Performance Indicators (KPIs) in assigned systems, with input andoversight from the assigned PM.Communication:- Keeps Project Leadership and Clinical Research Associates (CRAs) fully appraised of sites and study status.- Schedules and attends internal and external team meetings. May lead internal team meetings and portions of external team meetings as directed by assigned PM.- Prepares and distributes all meetings minutes for both internal and external meetings. Follows-up with team members on action items from meetings.- Prepares for and attends Investigator Meetings, Kick-Off Meetings, Quick Start Camps, and Quality Finish Camps.Training:- Trains new employees assigned to project.Project Leadership:- Serves as primary customer contact when PM is out of the office. Seeks input from Project Director for customer support Show less

The wisteria collective
Feb 2016 - Jul 2016Intern wedding coordinatorCasual wedding co-coordinator

Psi cro ag
Jun 2018 - now1. Site Management- Exchanges data, documents and other project relevant information between investigative sites and project team- Assists with clinical supplies (including medication) order, receipt, inventory storage, distribution, return/recall and reconciliation - Supports LEC/IRB submissions and notifications - Coordinates financial and contractual tasks (budget and contract negotiation with sites)- Under supervision, assists with preparation and follow-up of site and systems audits and inspections2. Other Communication- Exchanges data, documents, and other information with the project team and vendors- Maintains study-specific and corporate tracking systems3. Training- Involved in on-the-job coaching of Clinical Trial Administrators4. Document Management- Maintains Project Master File (PMF)- Performs PMF review and oversight at country and site level- Under supervision, assists in preparation and follow-up of PMF audits- Prepares, distributes, and updates Onsite Study Files (OSF) and OSF checklists- Provides assistance with translations5. Safety Management- Assists with safety information flow between investigative sites and the project team6. Corporate/Departmental Assignments- Assists in coordinating feasibility research and outreach. Show less
Clinical Research Associate II
Apr 2021 - nowClinical Research Associate I
Feb 2019 - Apr 2021Senior Clinical Trial Administrator
Jun 2018 - Jan 2019
Licenses & Certifications
- View certificate

Design and interpretation of clinical trials
CourseraMar 2014
Honors & Awards
- Awarded to Melissa ThompsonBusiness Unit - High Performance Team Award INC Research Aug 2016 This award recognized the AbbVie M14-011 team that has gone above and beyond in contributing towards our Business Unit/Department’s success in terms of their quality of work, teamwork, communication, initiative, customer focus (internal and external), compliance, commitment, resourcefulness and/or leadership.
- Awarded to Melissa ThompsonBusiness Unit - Key Contributor Award INC Research Jun 2016 Recognizes employees who go above and beyond in contributing toward the Company’s success. In this case, the award was given for my contribution on CSL's 654-3003 study which led to an approval of a hemophilia-b drug this year.
- Awarded to Melissa ThompsonBusiness Unit - High Performance Team Award INC Research Mar 2015 This award recognized the AstraZeneca D6011C00003 team that went above and beyond in contributing towards their Business Unit/Department’s success in terms of their quality of work, teamwork, communication, initiative, customer focus (internal and external), compliance, commitment, resourcefulness and/or leadership.
Volunteer Experience
Fundraiser
Issued by Dry July on Jul 2016
Associated with Melissa Thompson
Languages
- enEnglish
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