HIGHLIGHTS

* ***** ** ******** ******** Associate experience.

Most recent workload consisted of 3 studies and 14 sites in Cardiology, Central Nervous System, and Endocrinology

Heaviest workload consisted of 4 protocols and 16 sites in CNS, Infectious Disease and Cardiology.

Phase II-IV

THERAPEUTIC EXPERIENCE

Central Nervous System - ADHD

Cardiovascular - Hypertension

Infectious Disease - HIV

Endocrinology-Diabetes Type 2

PROFESSIONAL EXPERIENCE

Tinduke International

June, 2013 – Date

Project Coordinator

Coordinates export of medical aids to developing countries (West Africa)

Participates in Medical Mission – recent mission, 07/2014 – Medication for AIDS relief

Maintains records for tracking patients/outcome

Prepares reports, and publication materials for local healthcare pamphlets

Cliniqua Clinical Trials, Basking Ridge New Jersey

November 2007 – May 2013

Regional CRA

Perform the full range of clinical research site management responsibilities and ensure that study is conducted according to the protocol, ICH GCP, IRB provisions, regulatory requirements and sponsor SOPs

Investigator site identification, evaluation and selection, including pre-study site visits and feasibility studies

Site study start up activities including budgeting, contract development and negotiations, site initiation visits, and GCP instruction to investigators/research personnel

Set up new research sites and guide sites on submission of regulatory documents.

Participate in site training during Investigator Meetings

Ongoing monitor visits to conduct source data verification, drug accountability, query generation and resolution, SAE verification and reporting oversight, regulatory file review and oversight, document submission for central archiving, monitor reports, general site support and communication.

Troubleshooting and problem solving at sites to achieve turnaround results

Training and re-training of new research personnel, including Study Coordinators, Investigators, and site pharmacists

Site closure visits and tasks including test article reconciliation and disposition, review of accuracy and completeness of study files, and retrieval of all outstanding documents

Proficient in multiple, different Electronic Data Capture and report writing systems

Develop project specific tools and documents, such as protocol deviation and adverse event databases and reports

Gather and maintain documentation for site specific files in accordance with FDA regulations and company SOPs

Monitor drug inventory, dispensing, compliance and return

Track and report site enrollment, progress, and adverse events

Ensure that regulatory documents are complete and in compliance with federal and internal guidelines

Assure Investigator and site adherence to timelines and GCPs

Prepare and submit trip reports, expense reports, and timesheets.

Assist in the development of study source worksheets, CRFs, and tracking documents

Schering Plough, Kenilworth, New Jersey

October 2005 to November 2007

In House CRA

Full site management responsibilities

Process site payment

Manage Trial Master File

Order study drug and track shipment and delivery

Process the shipment of other study supplies

Process invoicing

Provide input for protocols

Assist in the development of clinical study documentation such as case report forms, informed consent forms, clinical study logs, study diaries, and study instruction sheets

Assist in drafting and reviewing clinical protocols for phase I - IV clinical studies

Assist in evaluating, and managing project specific clinical budgets and coordinating budget payments for study sites

Participate in the identification and selection of CRO Partners involved in Clinical Development studies/projects and review clinical site regulatory document packages prior to IRB submission

Health and Safety Executive, London, UK

June 1998 to January 2005

Senior Administrative Assistant

Maintained regulatory documentation to support onsite health and safety investigations.

Received files and other documentation to prepare summary reports

Assisted investigation team/lead inspector with administrative tasks to support investigation.

Performed quality control reviews on files to ensure work was performed in accordance with regulatory requirements

Liaised with members of the public, documenting health and safety complaints and responding to queries.

Developed strong working relationship across various departments and sites

Health and Safety Executive, London, UK

July 1996 to June 1998

Administrative Assistant

Assisted in the effective running of the office.

File maintenance and general administration.

Processed complaints / incident reports.

EDUCATION

Bachelor of Science, University of Phoenix - 2012

MBA level Informatics Certificate - 2014

COMPUTER SKILLS

EDC: Inform and Medidata Rave

CTMS: IMPACT and IWRS

Microsoft: Excel, Power Point, Outlook, Word.

Contact this candidate