Clinical Quality Assurance

NICK ANDERSON

Leo Pharma, Inc., Parsippany, NJ

March 2016 – Present

Senior Clinical Trial Assistant

Responsible for maintaining/modifying CDA data analysis excel spreadsheet

Reviewed patient data and patient profiles for accuracy during clinical trials

Used IVR system to monitor IP supply both domestically and internationally, monitor any potential temperature excursions

Worked in Study Stat-up area for several Dermatology clinical trials

Managed five Phase II Oncology Dermatology clinical trials

Verified and tracked all Serious Adverse Events and Adverse Events

Compiled, prepared, reviewed for accuracy, tracked all outgoing/incoming Clinical, Regulatory documentation

Worked with Senior Managers to ensure project timelines were met

Utilized both TMF, eTMF systems for archiving of Regulatory documentation

Assisted in budgeting process for participating institutions

Prepared team meeting agendas and meeting minutes

Prepared site/vendor payments

Coordinated team calendar management, travel arrangements and travel expense reconciliation

Utilized ISI Toolbox in assisting with the preparation of an electronic submission to the FDA

Mentored junior Clinical Trial Assistants

Bluestone Center for Clinical Research

May 2014 – Feb 2016

Clinical Trial Coordinator

Recruited and coordinated subject visits for phase I/II/III investigator-initiated and industry -sponsored clinical trials testing drug and consumer products in oncology and oral health

Prepared and managed clinical supplies and tracking information

Prepared and maintained Investigator Site File (ISF) and Regulatory Binder including FDA 1572, Informed Consent Forms (ICF), Financial Disclosures, protocol amendments/deviations, Investigator’s Brochure (IB), site delegation log, study product log

Managed source documents, Case Report Forms (CRF) and answered queries raised by monitor

Performed internal quality assurance for CRFs, regulatory documents and data on EDC system (Medidata RAVE)

Daiichi-Sankyo Pharmaceuticals

March 2013 to April 2014

Clinical Document Specialist

QC e-TMF for a Global Study with 121 sites.

QC content of Regulatory Documents from a Clinical Trial conducted globally.

Bayer Healthcare Pharmaceuticals

Clinical Support Coordinator

July 2012 to Feb 2013

Coordinate the start-up process and oversight greenlight for the IMP(Investigational Medicine Product) deployment to sites.

Coordinate the deployment of the Regulatory package to sites on a timely manner.

Coordinate the collection of essential documents for the IMP deployment to sites.

Participate and coordinate the PI (Principal investigator) Meeting that took place in Boston, USA. Collection and review of the completeness of essential documents necessary for the startup of sites.

Arranging & participating in the organization of Investigator Meetings & Study Team Meetings. Taking minutes & distributing.

Assist with the Ethics / Regulatory Submissions; keep a track of submissions & approvals for the study.

Preparing Protocols, Investigator Brochures and CRFs which includes keeping track and re-ordering supplies.

Set up and maintenance of the Trial Master Files (TMF) or Electronic filing systems/ set up of the Investigator Site File (ISF)

Managing and maintaining study documents & trial supplies e.g.; Patient Information Sheets, Patient Diaries, Lab Kits & Medical equipment for sites.

Preparing essential clinical trial documentation, distributing, tracking and filing of documents on return.

Ensure that any clinical trial databases/ tracking tools are set up and maintained throughout the trial

Create & maintain study contact lists for team/sites/3rd parties/set up mail merges.

Sending out Study Newsletters / Study Correspondence to all participating sites on an ongoing basis.

Setting up of finance systems accurately, processing invoices & tracking payments for the trial for investigator payments.

Assist with collating, tracking & shipping CRFs & data queries to Data Management

Processing SUSAR (Adverse Events) notifications in a timely manner

General study filing

Coordinating archiving of study documentation into TMF

TMF management

IMPACT Maintenance

Education:

Berkeley College- Bachelors Degree in Healthcare Management

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