Research Coordinator known for productivity and efficiency in task completion. Skilled in patient recruitment, regulatory compliance, and data analysis to ensure smooth operation of clinical trials. Excel at communication, teamwork, and problem-solving, using these soft skills to navigate challenges and drive projects to completion. Always focused on advancing research goals with precision and integrity.
Overview
1
1
year of professional experience
Work History
Pharmacy Assistant
Pharmacy Aseptic Production Unit (PAPU)
01.2022 - 03.2022
Working productively with the staff of PAPU to maintain the clean room according to SOPs and GCP guidelines
Stock rotation of medications and consumables
Assisting with the production of chemotherapy in temperature and pressure controlled chemo suite
Delivery of cytotoxic chemotherapy to the accurate locations, securely and efficiently
Ensuring GCP guidelines are adhered to, ensuring patient safety and privacy is of paramount importance
Managing the workload to achieve the data entry deadline, recognising and addressing barriers, and prioritising tasks to meet sponsor data lock deadlines
Maintaining accurate data in paper and electronic formats according to the trial protocols and ICH-GCP guidelines
Manage the closed studies and ensure they are archived according to the protocol and site standard operating procedures (SOP)
Assisting with screening potential trial patients for eligibility for the new studies, ensuring inclusion and exclusion criteria of the research protocol are met
Entering meticulous data into Medidata and RedCap and knowing how to submit documents to ethics for substantial protocol amendments.
Clinical Research Study Assistant
Te Toka Tumai (Auckland Hospital)
03.2022 - 03.2023
Working in the research unit, where trials are being conducted to find therapeutic agents for the prevention/suppression of advanced hepatocellular carcinoma, HepC, HepB, NASH, NAFLD and Wilson's Disease
Responsible for fulfilling administrative tasks, liaising with research nurses regarding patient scheduling, travel arrangements, and reimbursements, and promptly managing and tracking trial and unit-related finances
Entering clinical trial data with meticulous attention to detail, ensuring minimal query generation and liaising with the CROs and study site CRAs for any queries associated with collated data.
Clinical Research Coordinator
Peter MacCallum Cancer Centre
Conducting/coordinating phase 1- first in human clinical trials in solid tumours as per studyspecific protocols
Highly patient facing and cross functional research groups facing role
Working with terminally ill patients to provide investigational product and prioritising supervision of clinical wellbeing of the patient
Managing patient appointments, scheduling protocol-mandated assessments and maintaining ongoing communication with the patients
Recruitment, screening and enrolling eligible study participants as per the research protocol's inclusion and exclusion criteria
Ensuring accurate and thorough research documentation and informed consent
Providing patient with thorough education and support and addressing any concerns they may have through out their participation in trial and post trial
Responsible for conducting ECG and vital sign evaluation on study participants
Data collection and management of EDC such as MediData, RedCap, Veeva Vault etc
Additionally, ensuring all other trial related clinical notes post patient visits are up-to-date, new adverse events and concomitant medications noted
Resolving generated queries on EDC portals in timely manner
Liaising with sponsors, consistant communication site specific CRAs, principal investigators and other research team members such as central laboratories and other interdisciplinary teams to ensure efficient running of trial and promptly resolving any issues that may arise
Mainting and managing all study related supplies, i.e
Laboratory kits, ECG dots and papers, holter monitors, SD cards for data capture etc
This is to ensure availability of the required materials and equipments for patient visits
Assisting with the submission of regulatory documentations, final reports, project amendments and all other necessary documents to RGO and HREC
All procedures mentioned above are performed as per the ICH-GCP guidelines, NHMRC guidelines and the site approved standard operating procedures.
Education
Bachelor of Science - Pharmacology
University of Auckland
01.2021
NCEA -
Lynnfield College
01.2017
Skills
Patient screening and successful recruitment
Good Clinical Practice and SOP knowledge
Documentation Management
Scheduling proficiency
Data collection and analysis
Teamwork and Collaboration
Interpersonal Communication
Attention to Detail
Proficient EPIC EMR portal user
Thorough knowledge of NHMRC guidelines
Proficient user of microsoft Suite, Google Suite and GraphPad Prism
Aware of medical terminology and in-depth understanding of human anatomy and physiology
Languages (Speaking Understanding): English, Urdu, and Hindi
Hobbies and Interests
Hiking and Netball
Gardening
Painting and photography
Communicating with people
Learning about the new advancements in human health.
Jodi Van Dyk, Manager of Liver Research Unit, Auckland City Hospital, +64 21 581 015, Jodi.van.dyk@Auckland.ac.nz
Nathan Reader Wilson, Senior Clinical Research Nurse and Manager of EDD, Peter MacCallum Cancer Centre, 0410 431 946, Nathan.ReaderWilson@petermac.org
Timeline
Clinical Research Study Assistant
Te Toka Tumai (Auckland Hospital)
03.2022 - 03.2023
Pharmacy Assistant
Pharmacy Aseptic Production Unit (PAPU)
01.2022 - 03.2022
Clinical Research Coordinator
Peter MacCallum Cancer Centre
Bachelor of Science - Pharmacology
University of Auckland
NCEA -
Lynnfield College
Similar Profiles
Kevin MitchellKevin Mitchell
Investment Operations Specialist 3 at US Bank Tax Reporting Ops-Production Support UnitInvestment Operations Specialist 3 at US Bank Tax Reporting Ops-Production Support Unit
Computer System Validation Engineer at Grand River Aseptic Manufacturing Inc.Computer System Validation Engineer at Grand River Aseptic Manufacturing Inc.