SUMMARY:

• Over 14 Years of Pharmaceutical/CRO Industry Experience at ICON, Sanofi - Aventis, & Confidential
• Has worked as a Project Manager, CRA, TMF Assistant, Data Management Assistant, and Data Associate
• 3.5 Years of Project Management Experience in Pharmaceutical Industry at ICON and Confidential
• Currently oversees 6 studies: manages budgets, manages timelines, acts as direct link to vendors, and manages all email communications
• 3.5 Years of Trial Execution Experience at ICON and Confidential
• 2 Years of Clinical Development Experience at Confidential
• 3.5 Years of Experience with Editing Protocols and Amendments at ICON and Confidential
• 3.5 Years of Experience with TMF Review at Confidential
• 3.5 Years of Experience with Being the Main Liaison for Sites, Vendors, and Field Associates at ICON and Confidential
• 7 Years of Experience with Being the Main Point of Contact for CRAs at Confidential
• 3.5 Years of Vendor ManagementExperience at ICON and Confidential
• 3.5 Years of Resource Allocation and Management Experience at ICON and Confidential
• 5 Months of MS Project Experience at ICON
• Used an in-house program similar to MS Project at Confidential
• 3.5 Years of MS PowerPoint Experience at ICON and Confidential

TECHNICAL SKILLS

Skills: Rave, Oracle Clinical, ClinTrial 3.3, Clintrial 4.2, Clintrial 4.3 ClinFlow, PfizerClin Applications, EDC, Impact, eDocs. MetaTrial, Basic SQL, Data Entry, Data Loading, Data Validation, MS Office (Excel, PowerPoint, Project, Word)

PROFESSIONAL EXPERIENCE

Confidential, North Wales, PA

Project Manager

Responsibilities:

• Responsible for the overall direction, coordination, implementation, execution, control and completion of projects ensuring consistency with company strategy, commitments and goals.
• Provide project management leadership to cross-functional teams by integrating, facilitating, coordinating, and managing all activities related to the initiation, planning, executing, monitoring and closeout of assigned projects.
• Responsible for managing projects to ensure integration, coordination, and consistency of processes throughout project life-cycle, while coordinating and managing the activities of individual projects and team members in a manner that ensures all budgetary requirements, study timeframes and targets are met.
• Manage project in a timely manner in adherence with ICON’s SOP’s, ICH, GCP and appropriate regulation and liaise with other department managers as necessary.
• Deliver projects in accordance with the contract, timelines and study budget.
• Identification and review of change orders for the budget.
• Attend and present at client investigator, kick-off and client meetings.
• Co-development MIRA project set up.
• Ensure all necessary study specific training is provided to study team to improve performance and knowledge. Provide coaching/ mentoring as necessary.
• Manage eCRF development process.
• Develop/ review/ maintain all trial documentation (Charter, eCRF, SRS, Reviewer training manuals).
• Perform user acceptance training, demonstration of eCRF and data reconciliation.
• Act as primary client and CRO contact; develop successful working relationships with client/CRO.
• Prepare and manage meeting agendas and minutes.
• Prepare /Approve Project Reports.
• Coordinate readers and review sessions; Conduct reader training with support of Project Director.
• Monitor offsite Assessment/Blinded Reads and perform quality control of Offsite Assessments/Blinded Reads.
• Ensure all management tracking systems are up to date.
• Provide regular feedback to senior management on project status, client satisfaction and staffing issues.
• Manage data management lead for scheduling and preparation of data deliveries as required.
• Participate in BD activities as appropriate.
• Support internal, client and regulatory audits.

Confidential, Hershey, PA

Clinical Research Associate II

Responsibilities:

• Was responsible for the implementation of clinical research protocols, under the direction of Physician Investigators, including the evaluation of new clinical research protocols and submission of initial regulatory documentation and preparation of IRB applications.
• Coordinated and participated in a variety of complex activities involved in the collection, compilation, documentation and analysis of clinical research data.
• Completed understanding of the protocol elements and trial objections essential to running a trial and ensuring compliance
• Participated on appropriate internal committees and external organizations to assure compliance with appropriate regulations.
• Developed and implemented patient recruitment and education pamphlets, referring physician letters and source worksheets.
• Performed eligibility criteria, treatment, and enrollment procedures
• Facilitated scheduling subjects for research visits and research related procedures.
• Collected, recorded, and maintained records of all data collected for research participants.
• Measured trial outcomes.
• Collaborated with physician investigators and clinical research coordinators/specialists to monitor and manage patients’ care on research protocols.
• Evaluated new clinical research protocols for protocol feasibility, required research procedures, and associate effort.
• Collaborated with Investigational Drug Service to maintain accountability logs for storage and administration of study medications and maintains accountability logs for investigational devices.
• Performed staff in-service/education for research protocols and study drugs/devices as needed.
• Participated in study meetings.
• Screened for potential research participants through evaluation of inpatients and outpatients using inclusion/exclusion criteria and protocol-specified eligibility requirements
• Explained research study to potential participants and obtain informed consent prior to initiation of study related procedures.
• Captured all research data necessary to assess the outcome in clinical trials with Case Report Forms (EDC).
• Performed query resolution and completed SAE reporting.
• Collaborated with Investigational Drug Service to maintain accountability logs for storage and administration of study medications and maintains accountability logs for investigational devices.
• Submitted required initial regulatory documents and preparation of IRB applications.
• Performed clinical research in collaboration with other medical and nursing personnel and ancillary departments (laboratory, cardiology, radiology).
• Under general direction, assisted with basic laboratory procedures including blood, tissue and/or body fluid collection, processing and shipment to central laboratories (if required).
• Assured completion of protocol specified procedures (i.e. Echocardiogram, MRI, EEG etc…).
• Served as a liaison for ongoing communication between PSHMC faculty investigators, research participants and their families, research support associates and data specialists for the protocols.
• Prepared required regulatory and IRB ongoing study documentation including annual progress reports, protocol amendments and safety reports.

Confidential, Malvern, PA

Clinical Project Associate

Responsibilities:

• Worked directly with the Director of Oncology and the Medical Advisor in the study planning and set up activities for an Oncology/Cardiovascular pilot study.
• Identified and solicited investigators and institutions for participation in the pilot study per in house database system.
• Distributed feasibility questionnaires to investigators and/or institutions.
• Was responsible for tracking of responses, verifying the status of investigators in IMPACT, and confidentiality agreements.
• Worked directly with Clinical Project Leader as the primary contact for a (SMA) Scientific Medical Affairs Phase IV study.
• Acted as primary contact for regional CRAs and vendors for study issues and resolutions.
• Maintained a tracking system to provide weekly reports to Clinical Project Leader.
• Scheduled and participated in study team calls with Project Leader to review study progress with regional CRAs and vendors

Confidential

Clinical Project Associate

Responsibilities:

• Worked with US Clinical Project team to assure the successful completion of US and Global clinical trials.
• Was responsible for financial aspects associated with trial (i.e investigator grant payments track payments, and resolve inquiries).
• Assisted in preparation of monitoring team and site teleconferences.
• Managed Investigational Product supply, including shipment, tracking, and reconciliation, clinical supplies, including assessment of needs, shipment, and maintenance.
• Maintained project-specific applications and clinical trial monitoring/management systems.
• Corresponded daily and follow-up via phone and e-mail with investigative sites.
• Addressed general site questions and direct concerns to appropriate monitoring team person(s).
• Received several recognition awards for accomplishments and achievements on study teams and work groups.
• Coordinated study payment process to include reconciliation to verify payments amounts, correct overpayment errors.
• Prepared operational and administrative aspects of site selection and initiation and assist sites with the preparation of required regulatory documents for initiation.
• Distributed, reviewed, and retrieved regulatory documents required for initiation and maintenance of trial (i.e., CVs, FDA 1572, Lab Certification, Financial Disclosure and normals, etc.)
• Ensured execution of confidentiality agreements and contracts.
• Assisted in the site selection process; processed site feasibility and assessed interest.
• Took appropriate action to assist in resolution of any outstanding issues found during monitoring visits by CRAS.
• Assisted in the distribution of IND Safety Letters to investigators.
• Tracked patient screening, enrollment, recruitment, and retention activity.
• Distributed mass mailings of study documents to sites.
• Facilitated close-out activities: tracking, review, and reconciliation of documents, and archiving.
• Performed file audits; assured currency of required clinical trial documents within central and investigator files, Track, scan, and file regulatory documents.

Trial Master File Assistant

Confidential

Responsibilities:

• Oversaw the management of clinical essential documents and critical regulatory documents for assigned projects/studies.
• Ensured documents collected during the conduct of a study were appropriately logged, disseminated, and filed.
• Maintained an archive-ready file per Standard Operating Procedures requirements throughout the course of the study.
• Completed initial receipt, logging, and secured storage of Local Study File related documents.
• Performed file review to ensure integrity and accuracy.
• Scanned documents as appropriate and/or logged documents into database.
• Performed administrative tasks to maintain order inventory of file-related labels, folders, and miscellaneous supplies.
• Contributed to regulatory submissions by providing relevant clinical documentation in submission format to regulatory functions within research and development.
• Ensured regular efficient and effective communication of clinical document issues and progress to study teams via team meetings and/or electronic communication.
• Participated in audit preparation.
• Worked with study teams in preparing essential documents for quality and compliance audits.
• As requested, provided input for training programs to ensure up to date information for all processes.
• Participated in work groups & task force teams relative to coordination, processes, and procedures.
• Was Lead Data Acquisition Assistant for two psychiatric studies, consisting of 450 patients that used an automated system to compile case report forms for regulatory submissions.
• Was responsible for the receipt of CRF’s, scanning, quality control, validation, and archiving. Performing study tasks including data review, query generation and resolution, AE and medication coding, SAE reconciliation, document tracking, file maintenance.

Data Acquisition Assistant

Confidential

Responsibilities:

• Entered and/or verified source data into pre-established databases.
• Tested data entry for new studies.
• Utilized resources to resolve data entry problems associated with processing data from a variety of sources.
• Identified and resolved issues/problems that prohibit normal data entry by using acquired experience and expertise; issues/problems may include, but are not limited to illegibility and inappropriate form completion or use of database.
• Assisted the DMS Manager in prioritization of work and staff allocation to protocols.
• Tested new database designs and data entry panels for efficiency of data entry.
• Trained new permanent and temporary staff in data entry. Provide training on new protocols and instructions.
• Generated weekly and monthly status reports on CRF’s processed.
• Ran quality control reports on data entry.
• Facilitated data cleanup to expedite database lock.
• Routinely consulted reference books to clarify medical terminology for data entry.

Document Management Assistant

Confidential

Responsibilities:

• Was responsible for processing and maintaining accurate and secure document files, which may be audited by or submitted to Regulatory Agencies.
• Was responsible for records management to include logging, scanning, indexing, filing, photocopying and distribution.
• Assigned appropriate indexing parameters to clinical documents.
• Assisted or prepared documents for submission to Regulatory Affairs

Confidential,Lionville, PA

Clinical Data Coordinator

Responsibilities:

• Was responsible for validating the clinical trial database according to protocol, guidelines and timelines.
• Collaborated with monitors and site personnel to resolve issued queries and non protocol data trends.
• Validated data screens and edit programs presenting issues to manager.
• Coded adverse events and medications using MedDRA and WHO Drug Dictionaries.
• Loaded external data and resolved outlying issues via query or direct contact with vendor.
• Produced study status reports and listings for internal and external teams.
• Reconciled data captured on multiple databases including, Pharmacokinetics, Central LAB, Serious Adverse Event, interactive voice response system.
• Led a team of five individuals in which duties entailed entering vital information from case report forms into a database for major pharmaceutical sponsors.
• Liaised with major pharmaceutical sponsors, to assure that all clinical documents were entered and verified per stringent deadlines, and addressed any issues that may prevent their timely release.
• Evaluated and prioritized project timelines in order to meet aggressive deadlines.
• Forecasted all upcoming deliveries of electronic CRF’s, through a T-3 line from Groton, Connecticut, and worked closely with the manager to ensure adequate resources were allocated.
• Processed case report forms and discrepancies from investigational sites into a proprietary tracking system
• Resolved case report forms and discrepancy issues within Data Management, Clinical Sites and Central Files
• Implemented and revised Standard Operating Procedures for various audits.
• Handled one on one contact with clients to provide the proper methodology involving vital case report form information.