Nick Marshall Email & Phone Number

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 is currently opportunity to assist sponsors in these activities on short or longer term contractual bases, working directly with sponsors through their specific company organizational structure as an ‘outlier’ or ‘field worker’ attending clinical study activities in Australia and New Zealand, thus providing a seamless integration with sponsor procedures. Proven experience in general study related activities as well as "rescue" work for clinical trials, including: PD-1 / PD L-1 inhibitor studies treating various cancersNon-small cell lung cancerMetastatic MelanomaIntractable pain (new drug and novel delivery device)Seven cardiology device studies (various sponsors / various devices)Endarterectomy deviceHeart valve replacement study (audit)Biventricular pacingCardiac resynchronisation therapy device (CRT-D)HIV vaccine (17 Thailand sites)Nutrition Gene TherapyInfluenza vaccine (novel administration device)DIC / Sepsis (Phase II ICU)Gynaecologic device studiesCardiac Ablation TherapyCervical Device studyVarious "secondment" / "in-house" positionsExperience with Medidata-RAVE, RAVE-X, INFORM, SILK et al / company specific e-CRFs and CTMS

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 activities, billing, etc., etc.

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 activities.

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 industry.

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

Ccra, Clinical Research

Ongoing CCRA accreditation maintained since 2008 per ACRP procedures.

Graduate Diploma Of Health Sciences- Hiv Studies, Health Sciences

Bachelor Of Nursing, Nursing

Activities and Societies: Vice President of the Student Representative Council 1985 - 1987

Ancient History And Linguistics