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Nick Marshall is listed as Managing Director at Nicholas Marshall and Associates P/L at Nicholas Marshall and Associates P/L, based in Sydney, New South Wales, Australia. AeroLeads shows a work email signal at iinet.net.au and a matched LinkedIn profile for Nick Marshall.
Nick Marshall previously worked as Managing Director at Nicholas Marshall And Associates P/L and Senior CRA at Chiltern International. Nick Marshall holds Ccra, Clinical Research from Association Of Clinical Research Professionals (Acrp).
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Twenty-seven years experience in clinical research working on studies of drugs, drug delivery systems, devices and biologics with responsibilities for all aspects of project management commencing with the first position held in the industry. Continuing work as an independent contractor working on various studies of differing phase (phase I - IV) in different therapeutic areas including pharmaceuticals / devices / biotechnology / gene therapy. Working knowledge of FDA, TGA (Australian Therapeutic Goods Administration) and ICH / GCP regulations and standards. Proven track record as a field-based SCRA / Project Manager and assistance with clinical trials "rescue" work.Specialties: Project ManagementFeasibility / Site / Investigator selectionStart-up / Ethics submission writingClinical Monitoring / eCRFs including CTMS / RAVE et alCRF designPlanning and problem solvingNegotiating contracts / budgetsSite / investigator paymentsInternational / regional field-work"Rescue" work
Listed skills include Clinical Monitoring, Crf Design, Negotiating Contracts, Clinical Research, and 32 others.
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Sydney, Australia
Nicholas Marshall & Associates Pty. Ltd. is a consultancy providing personalised service to companies / sponsors requiring assistance with feasibility and study start-up activities, regulatory and Australian quarantine issues, monitoring and other help setting up and undertaking clinical trials of drugs and medical devices in Australia, New Zealand. There.
Sydney, Australia
Contracted as a Senior CRA undertaking full Start-up Specialist, Country Specialist and other in-depth clinical study related activities including: feasibility work, all study start-up duties, regulatory submissions / documentation, contract negotiations, HREC applications, monitoring, SAE / SUSAR safety reporting, follow-up and tracking, study close-out.
Undertook monitoring responsibilities for: a multi-centre, valve replacement study; multi-centre, biventricular pacing study and a multi-centre cardiac resynchronisation therapy (CRT) study using biventricular (BiV) pacing. Two of these studies were running concurrently.
Undertook Senior CRA responsibilities (monitoring, investigator / site payments, study device deliveries etc. etc.) for four clinical studies in various therapeutic areas, including various Ethics Committee submissions for sites, site qualification / evaluation / reviews & initiation visits, and other study start-up, problem-solving and maintenance.
Contracted by Clinimetrics to work as a Field CRA over seven years on multiple multi-centre, multi-national clinical studies of drugs and medical devices. Contract with Clinimetrics concluded when Clinimetrics was absorbed by Omnicare Clinical Research which had it's own offices and CRA staff in Sydney.
General Team Leader responsibilities, staff management and study related duties (staff training, intl. Investigator Meeting attendance, EC / IRB submission writing, site identification and review). Left position to take up independent contractor role.
Data management responsibilities for a large multinational clinical study including data entry into the database, data auditing, and generation and resolution of data queries for final data entry. Some training of data entry clerks regarding interpretation of data related to the study protocol.
General SCRA responsibilities / study related duties including: European head office company training, international Investigator Meeting attendance, EC / IRB submission writing, site identification and review, Phase I ICU nosocomial pneumonia antibiotic study monitoring, initial setup of four separate antibiotic studies.
General CRA responsibilities / study related duties including: Project Management for two HIV studies, prototype device study, Antibiotic study (phase III), Closed Head Injury (phase II ICU), Antidepressant study (Phase III, for use in driving), CRF design, EC / IRB submission writing, site identification and setup, initiation visits, monitoring, closeout.
Clinical Trial Coordinator at the premiere HIV research facility in Australia. Coordinated and managed seven large, longitudinal, multinational studies of different phase (phase I through phase III) drugs and biologics for the treatment of HIV and related conditions. Studies were sponsored by government departments and the international pharmaceutical.
Managing the Day Treatment Centre for people living with HIV / AIDS requiring ongoing treatment for HIV and related conditions.
General hospital care for people living with HIV / AIDS including acute and palliative care.
General Registered Nurse duties in a Veterans Hospital setting working with male and female patients in Female Medical (Cardiology/Respiratory/Oncology), Male Surgical, Renal, Orthopaedics and Operating Theatres
Ongoing CCRA accreditation maintained since 2008 per ACRP procedures.
Activities and Societies: Vice President of the Student Representative Council 1985 - 1987
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Nick Marshall works for Nicholas Marshall and Associates P/L.
Nick Marshall is listed as Managing Director at Nicholas Marshall and Associates P/L at Nicholas Marshall and Associates P/L.
AeroLeads has found 1 work email signal at @iinet.net.au for Nick Marshall at Nicholas Marshall and Associates P/L.
Nick Marshall is based in Sydney, New South Wales, Australia while working with Nicholas Marshall and Associates P/L.
Nick Marshall has worked for Nicholas Marshall And Associates P/L, Chiltern International, St Jude Medical - Australia, Johnson & Johnson, Medical Australia, and Clinimetrics.
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Nick Marshall holds Ccra, Clinical Research from Association Of Clinical Research Professionals (Acrp).
Nick Marshall is listed with skills including Clinical Monitoring, Crf Design, Negotiating Contracts, Clinical Research, Clinical Trials, Therapeutic Areas, Cro, and Edc.
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