Qualifications Profile

Summary

Overall, ** plus years’ experience in a clinical regulatory environment within the biotech, academic, pharmacogenomics industries and CRO. With over 5.5 years as a successful Clinical Research Associate for clinical research studies, through effective and motivating relationship building. Broad-base responsibilities and skills in the following areas include:

Leadership & Organizational Skills Analytical Skills

Project Assistant Problem Solving/Solution Selling

Client Relations Quality & Performance Improvement

Training

Summary of Experience:

13 plus years of experience in pre-clinical and clinical research

oexperience in Phase IB, Phase II and III clinical trials

oEDC experience in clinical trials

oPharmacogenomics research

oAssisting trials in interim and final database lock.

Therapeutic Experience:

Macular Degeneration; Pancreatic Cancer, (GenVec)

Cardiovascular; Congestive Heart Failure (Otsuka)

Cancer

oHPV Cervical Cancer (Digene)

oPancreatic, Breast Cancer, Bladder Cancer (Rexahn Pharmaceutical)

Autoimmune sector - Rheumatoid Arthritis (Protalex)

Polished professional with expertise in quality / document control functions and audits, leveraging wealth of talents.

Thorough understanding of quality initiatives, control, and organizational structure combined with hands-on experience in planning, developing and overseeing procedures.

Exemplary record of accuracy and diligence in preparing, organizing, tracking and verifying lengthy, complex documents essential to research studies.

Strong communicator, interacting effectively with all functions and departments as well as remote research sites.

Organized and analytical, with exceptional attention to detail, ensuring maximum accuracy in complex reports and adherence to deadlines.

Recognized for initiative, ability and problem-solving skills as well as willingness to take on new responsibilities.

Assist with protocol development, design and review; verification and validation of medication safety; recruitment of study participants; administration of informed consents; sample and study document preparation; and data collection, interpretation and analysis.

Professional Experience:

Clinical Trial Assistant – (Aerotek Contractor with Prometic)

January 27, 2020 – June 30, 2020

As a Clinical Trial Assistant (CTA) with Prometic (specializes in discovering, developing and commercializing novel small molecule compounds for respiratory, liver and renal diseases. Focus specifically on developing solutions for rare and orphan diseases) work independently and responsible for :

Assist with obtaining documentation for the BLA submission and assist the Quality Assurance (QA) in preparation for BLA submission requirements.

Set up, manage and maintain clinical study documentation using the DIA Trial Master File (TMF) structure: Ensure receipt, completeness and accuracy of clinical and administrative documents;

Assist the clinical operations team in the preparation, handling, electronic distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures;

Prepare and maintain the Trial Master File (TMF) and Site Files using the DIA TMF file structure, create Investigator Site Files (ISFs), local study files and regulatory files (as applicable);

Provide quality review of all collected site documentation prior to filing in the local study files to ensure that the study files are current, accurate and complete;

Assist in the coordination of study initiation documentation materials;

Coordinate the ordering, the distribution, the shipment and the tracking of study-related materials;

Attend internal and external project meetings, help to produce presentation materials;

Facilitate flow and maintenance of correspondence with sites and contract research organization personnel;

Perform essential documents review, maintenance and reconciliation prior to close-out activities;

Other related duties/responsibilities as required or assigned by the supervisor.

Clinical Trial Associate – (Advanced Clinical Contractor with Rexahn Pharmaceutical)

May 2018 – November 15, 2019

As a Clinical Trial Associate (CTA) work independently and solely responsible for the collection, review, tracking, maintenance and archiving of essential study documents in the Site and Trial Master File (TMF) using the DIA TMF file structure, ensuring that project specific administrative documents are maintained. Was Primary Point of Contact of the TMF and Site Files. Prior to the end of my contract, Managed Site Closure working with the Lead CRA in obtaining all essential study documents for trial. Assisted Clinical Associate Director in writing Note-to-File’s documenting attempts to collect missing Site and Trial Master File documents.

Collects, distributes and tracks receipt of regulatory documents and other trial related documents through the life cycle of the clinical trial as needed.

Creates and maintains logs of trial related documents. Distributes and tracks reports to clinical trial sites and IRBs.

Distributes and tracks protocol deviations. Distributes, tracks, collates and summarizes feasibility information and provides to study team as needed.

Maintains trackers for essential trial related documents as needed.

Assisted and supported Lead Clinical Research Associate (CRA) and Project Managers in numerous tasks related to the Trial Master File and Site File’s.

Provides administrative support to study team for trial related tasks and in-house support for clinical trial operations including interacting with the clinical research associates (CRAs), maintaining appropriate in-house trial documentation and providing general support for the clinical operational activities.

Ensures clinical trial documents are filed/uploaded accurately and within expected timelines.

Close-Out of sites – work with Project Leader and CRA’s in collection of essential documents and licenses nearing expiration prior to site closure.

Duties and Responsibilities

Provide administrative support to the Clinical/Regulatory project team

Assists the Project Manager (PM) with written and verbal communications to the study team and sites

Reviews Clinical/Regulatory documents submitted to the Site Master File (SMF) by the study team for

accuracy, completeness, and compliance with internal and Client quality standards to fulfill all federal

and local regulations

Ensure paper SMF documents are named according to standard naming conventions

Assist the project team with reconciliation of the periodic SMF QC

Assist in the close-out of projects by performing a final QC of the SMF, identifying items and issues for review and/or follow-up by the CRAs.

Assist in drafting note-to-files documenting attempts to collect missing Site File documents

Clinical Trial Assistant – (Axeon-US – Tasly Pharmaceutical - Contract)

June 2017 – January 2018

As a Clinical Trial Assistant (CTA), create and organize clinical trial master file documents, Regulatory Site Binder, including clinical study site documents, email correspondence, training materials and other study documents. Also generate filing indexes and maintain currents lists of correspondence. Administer clinical trials according to good clinical practices (GCP) and standard operating procedures, and work as a liaison with review boards and independent ethics committees. Act as key contacts between the contract laboratory, study team and study site. Also provide general logistical support for clinical trials, such as creating an agenda and taking minutes at meetings, and assisting with purchasing and/or budget activities. Also oversee creation and management of Axeon-US Standard Operating Procedures (SOPs). As Axeon-US does not have any SOPs in the beginning stages of creating for Axeon-US which is a Contract Research Organization (CRO).

Quality Assurance, Operations Associate - (Aerotek – Contract at MedImmune)

March 2014 – August 2014 Gaithersburg, MD 20878

As an Operations Associate, performs a variety of QC, reporting, and administrative support for the Medical Writing Clinical Operations Department. Interface with Medical Writers performing a variety of QC with various document/reports. Responsible for Quality Control (QC) review of Clinical Regulatory documents and providing other Operational Support to the Medical Writer group, including management of electronic document repositories and project tracking systems. Works under general supervision to manage and prioritize workload to ensure deliverables are completed per time and quality goals.

Protalex, Inc., Gaithersburg, MD (per diem started March 2010 part-time was offered full-time permanent position June 2016)

In-House Clinical Research Associate / Document Control Administrator / Executive Assistant,

March 2010 February 2017 - (per diem started March 2010 part-time was offered full-time permanent position June 2016)

In multifaceted role, beginning with study startup for Phase 1b study, contribute to quality compliance through planning, standard operating procedure (SOP) development, and development of audit tracking system. Maintain electronic document control system, files and library; participate in management of quality programs. Implement relevant protocols and procedures and support QA and regulatory functions, ensuring full compliance as well as continuous quality improvement. Review and track regulatory documents; oversee remote monitoring; audit files and studies. Create and maintain project files; secure approvals and manage administrative requirements.

Coordinated and managed the day-to-day activities associated with the acquisition, processing, read sessions and data output deliverables for the clinical trial.

Consistently ensured that all documents submitted to QA Document Control complied with template, organization, content and quality requirements.

Create good manufacturing practices (GMP) and QA training materials to ensure consistency throughout organization.

Manage and maintain current records of employee credentials in accordance with applicable company policy.

Prepare and Manage clinical study’s regulatory binders.

Selected to assist in laboratory with time / date stamping for drug mixture and drug log.

AnGes, Inc., Bethesda, MD (Permanent)

Clinical Trial Associate March /2015 – June 2016

Core responsibilities applicable for studies following electronic trial master file (eTMF) procedure:

Supports Clinical Trial Leaders (CTLs) in the setup of an electronic Trial Master File (eTMF) process for assigned studies

Work with document systems and related group to ensure groups are trained on document management systems or other agreed process for electronic TMF document delivery

Work with sites to attain required regulatory documentation in a timely manner as required to meet timelines for study start up

Support CTLs in the maintenance of trial documentation.

Scan (or coordinate scanning by vendor), properly name, and import documents into the document management system.

Act as subject matter expert and/or super user for document systems and other TMF technical tools.

Support set-up of electronic TMF Table of Content at study start and update as appropriate during study in agreement with CTL

Set-up of paper TMF folder structure & receipt of paper TMF documents from the Clinical Research Associate (CRA)/site at defined intervals during the trial for those originals still required to be on file, arrange for archiving of paper TMF at study end.

Arranged offsite for study committee members in New York City which included meeting room set-up and catering for group.

Manage Contract Accountability and establish expense tracking for invoices and vendors associated with the Clinical Trial. Maintain Contract and invoicing for Consultants as well as Vendors for the Clinical Trial

Otsuka Pharmaceutical Group, Rockville, MD (Aerotek Contract)

Clinical Document Specialist, June 2006 July 2009

Managed all electronic / paper clinical trial documentation, ensuring adherence to quality and regulatory requirements. Gathered, tracked and managed clinical information; conducted detailed, comprehensive document audits and verified accuracy. Prepared due-diligence correspondence

Located essential documents for inclusion in appropriate Trial Master Site Files.

Document management – Scanning, Filing, Retrieval and Organization of controlled documents in accordance with applicable company policies and procedures and regulatory requirements.

Utilized department databases/spreadsheets to track and manage controlled documents.

Earned recognition for diligence and thoroughness in document management, significantly improving process efficiency and reliability.

GenVec Corporation, Gaithersburg, MD (Permanent)

Clinical Trials Assistant, June 2005 June 2006

Coordinated and managed documentation essential to clinical and regulatory compliance, including auditing, logging, tracking and storage. Supported site audits during patient enrollment phase.

Ensured high levels of accuracy and 100% completeness in all documentation.

Held key role in start-up and launch of clinical trials through expertise in documentation and regulatory support.

Issuance of controlled document copies.

Accepted challenge and managed 2+ weeks of study during supervisor's unexpected absence, earning commendation from medical director for diligence and quality performance.

In managers absence,

I managed the program budget and oversaw site agreement/budget negotiations.

I oversaw the submission of trial-related and essential documents to the Trial Master File.

Digene Corporation, Gaithersburg, MD (Permanent)

Administrative Assistant, March 2003 June 2005

Assisted with the company’s preparation for their FDA Panel Review for the company’s Medical Device Approval. Assisting with included various components involved with preparation for final reports to be presented at meeting, oversaw travel and accommodations for scheduled speakers.

Assisted in coordinating and managing documentation essential to clinical and regulatory compliance, including assisting with Regulatory Submissions in paper formats as well as eCTD, also assisted with auditing, logging, tracking and storage. Supported site audits during patient enrollment phase. Also coordinated and interfaced with management and employees to document and develop policies and procedures supporting multiple products. Managed calendars and schedules, oversaw travel / accommodations, scheduled speakers and prepared conference documentation.

Adeptly organized and managed numerous priorities to meet deadlines and ensure adherence to required standards for FDA Panel Review.

* * *

Additional roles as Control Document Administrator with Accelovance, Inc., Rockville, MD and EntreMed, Inc., Rockville, MD.

Previous position's held prior to 2005 were Executive Administrative Assistant/Technical Writer with Fusion UV, Gaithersburg, MD(2000) and Executive Administrative Assistant's with: Lockheed Martin, Bethesda, MD; Marriott, Inc. (Corporate Headquarters, Bethesda, MD), Government Contractor's Vitro, Inc.(1985); and Tracor, Inc. (1981)

Educational Background

Bachelor of Science in Business Administration, 2004

University of Phoenix

Associate of Arts, Secretarial Science, May 1986

Montgomery Community College

Certificate in Clerical, Executive & Medical Secretarial Studies, May 1981

Pennsylvania College of Technology – Williamsport, PA

Certifications:

Good Clinical Practice (GCP), AnGes, Inc. 2016

Data Management for Clinical Research, 2016

Regulatory Writing + Epidemiology & Biostatistics, 2010

Professional Development:

Guide to Writing and Maintaining Standard Operating Procedures (SOPs), 2011

Microsoft SharePoint, 2010

Internal Auditor Course, Quality Gurus.com, 2010

Protecting Human Research Participants, NIH Office of Extramural Research, 2010

Comprehensive Monitoring for Medical Devices, Barnett International, 2004

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