PROFESSIONAL EXPERIENCE

Confidential, Wynnewood, PA

Analytical Development Assistant/Admin

Responsibilities:

• Assists Clinical Scientist and Project Managers wif protocols, study Reports,, budgets, IRB submission
• Assists Clinical Resource Specialist wif inventory and preparation of supply shipments for all ongoing clinical trails
• Assists Clinical resource Specialist wif receipt and aliquoting of samples, distribution and shipping of samples to internal and external sties
• Assists Clinical Data Associate in data management tasks for clinical trials (me.e. data entry and QC)
• Perform various trial - related functions as required and assigned to ensure the accuracy, quality and timely execution of clinical trials per Good Clinical Practice (GCP) and SOPs, which includes and is not limited to: reviewing protocols and study reports
• Sets up and maintains study design binders (me.e., review for organization and reconcile for completeness) and department files for Clinical Affairs
• Provides support for the Clinical and Regulatory departments
• Follows all company environmental, health and safety policies, procedures and guidelines and conducts work in a safe manner
• Other duties as assigned

Data Validator & Scanning Assistant

Confidential, Marlton, NJ

Responsibilities:

• Work wif the customer to define the problem statement and goals of the project.
• Conducts data requirements analysis including the development of the logical data model based on data definitions and business rules as well as the high level design of system work flow.
• Provides strategic guidance and technical assistance to improve data collection, data mining, analysis capabilities.
• Develops and conducts complex data validation and reconciliation to ensure data integrity, accuracy and completeness for operational purposes.
• Create insightful reporting and analytical solutions through data visualization techniques for delivering information more TEMPeffectively to end users.

Document Management Assistant

Confidential, North Wales, PA

Responsibilities:

• Process study documents in accordance wif client and study requirements as per study specific processes, ICON SOPs/WPs and regulations, where applicable.
• Liaise wif study teams and other Document Management staff in order fulfill job responsibilities and activities for Pfizer Trial Master File.
• Complete department projects as assigned in accordance wif specified timelines, ICON SOPs/WPs and regulations
• Maintain regulatory study files as per study and/or client requirements.
• Complete activities related to document receipt and processing.

Receptionist/Data Entry Team Support

Confidential, Plymouth Meeting, PA

Responsibilities:

• Answering Multi lines telephone system
• Retrieving and scanning incoming mail & Sending mail out Data Entry of Insurance New Business Submission for Underwriters
• Responsible for sending out Non Renewal & Notice of Cancellation Notices to Producers
• Retrieving Loss Runs Request for Agents/Producers

Data Entry Associate, CDM

Confidential, Washington, PA

Responsibilities:

• Performed logging, tracking and filing of CRFs.
• Scanned and Indexed CRFs and DCFs.
• Completed Data Entry activities according to ICH-GCP requirements following the SOPs and policies.
• Performed first pass entry into the clinical database.
• Performed second pass verification or equivalent quality check of the clinical database; analyzing and acting upon responses to correction requests.
• Communicated any and all issues to supervisor.

CCTR Data Entry Specialist

Confidential, Norristown, PA

Responsibilities:

• Reviewed required study/center data point information wif Remediation Lead and make required changes/ entries to Client Registry.
• Partnered wif Client Registry Business Administrator to override business rules as required.
• Performed relational QC as required between system and documentation as directed by Remediation Lead.
• Responsible for meeting client productivity metrics.

Sr. Data Lead Associate, Data Management (CDO)

Confidential, Wayne, PA

Responsibilities:

• Reviewed case report form data for completeness, accuracy, and consistency.
• Reviewed of electronic edit check output and the creation and resolution of queries.
• Assisted in the development of the data management plan.
• Created test data to facilitate the validation of study databases.
• Provided feedback to Data Managers regarding project status, data quality, and any issues.
• Participated in the QC review of study data.
• Entered lab normal ranges.
• Performed SAE reconciliation, medication coding documents tracking and file maintenance.
• Coding of medications and adverse events.
• Reconciled third party vendor data and Serious Adverse Events,.
• Coordinated the data flow for submission to a data safety monitoring board

Clinical Supply Coordinator

Confidential, Colegeville, PA

Responsibilities:

• Projected subject visit dates and supply test article to investigative sites participating in various neuroscience clinical trials
• Maintained inventory of test article at all participating sites (available, assigned, damaged, etc.)
• Collaborated wif study coordinators for weekly subject information updates
• Tracked all screened, enrolled, and dropped subjects throughout the study
• Collaborated wif Global Trial Leaders, Regional Study Managers, and Clinical Trial Support Specialists regarding shipment of drug and on any subject/staff changes at sites
• Processed shipping requests for test article in Prodstar, ensuring drug is delivered and available at the sites prior to subject visits

Unblinded Project Manager

Confidential

Responsibilities:

• Collected unblinded documents for infectious disease clinical trials
• Scanned and Uploaded unblinded documents into Confidential Official Repository (WOR) after study completion and unblinding of data
• Responsible for RAVE third party data entry for an anti-infective compound

Drug Re-supply Coordinator

Confidential

Responsibilities:

• Responsible for supplying test article to investigative sites participating in infectious disease clinical trials
• Maintained inventory of test article at all participating sites (available, assigned, damaged, etc.)
• Obtained weekly drug inventory from all sites and patient information visit updates
• Tracked all screened and enrolled patients throughout study duration
• Collaborated wif Clinical Trial Manager and Clinical Trial Support Specialists on any subject/staff changes at sites
• Collated and reproduced investigator meeting materials as necessary
• Tracked site initiation dates, and all Study Coordinator/Pharmacy contacts and addresses for initial drug shipments and site initiation visits
• Tracked all received confirmation of shipment receipts and site-to-site transfer forms

Clinical Data Entry Specialist

Confidential, Wayne, PA

Responsibilities:

• Resolved entry discrepancies indicated during double data entry to ensure accurate data
• Logged and tracked case report forms (CRFs) for data entry
• Performed database updates and changes resulting in clean data
• Performed minor database audits and corrections to ensure accurate data
• Trained staff on data entry systems maintaining consistency among the staff as well as accurate data
• Performed validation or testing of data entry systems to ensure the compatibility of the database versus the CRF

Data Acquisition Assistant

Confidential, Malvern, PA

Responsibilities:

• Performed the initial receipt, logging and distribution or storage of clinical trial related documents
• Reviewed files to insure integrity and accuracy
• Identified and resolved issues dat prohibited normal data entry by using acquired experience and expertise
• Logged documents into a computer database or scan and electronically index
• Retrieved files upon request. Maintain day-to-day activity and performance tracking data. Prepare files for off-site archiving
• Performed daily tasks associated wif original entry and/or key verification of data generated by clinical trials
• Routinely consulted reference books to clarify medical terminology for data entry
• Provided data for monthly status report
• Performed other duties as necessary in Central Files or requested to meet business condition or changes as assigned by supervisor

Senior Clinical Data Entry Operator

Confidential, Radnor, PA

Responsibilities:

• Performed double data entry of CRFs through keying, optical scanning and/or remote data captures
• Resolved any data entry discrepancies to ensure accuracy
• Identified data inconsistencies, resulting in the creation of a data resolution form
• Generated and validated reports dat aided in the clean up of the database
• Logged, batched, scanned and track CRFs for data entry
• Performed database updates and changes resulting in clean data
• Performed minor database audits and corrections to ensure accurate data
• Trained staff on data entry systems, maintaining consistency among the staff as well as accurate data
• Performed validation or testing of data entry systems to ensure the compatibility of the database versus the CRF