Hardworking and passionate job seeker with strong organizational skills eager to secure Enterprise Shared Service Center Associate Specialist position. Ready to help team achieve company goals.
Overview
23
23
years of professional experience
Work History
Clinical Data Coordinator
ICON
08.2023 - Current
Data Entry Support for SIP Studies/Sites - make updates in SIP as provided on SIP ISIF forms and SIP ISI change forms
Create new/update existing reference data as needed
Enter site accounts and site contacts
Make updates as requested throughout the course of the study
Data Entry Support for Non-SIP Studies/Sites - make updates in CTMS as provided on pre-validated site lists, ISIF forms, ISI change forms, and change requests received via email
Review reference data to see if required account/contact/address records already exist in the system
Create new/update existing reference data as needed
Create sites, enter site accounts and addresses, enter site contacts and addresses, assigned required external system provisioning roles, Make updates as requested throughout the course of the study
Data Entry Support for Acquired Studies - create countries and/or sites, enter milestones and enrollment information for acquired studies
Make updates as trackers are received throughout the course of the study
Follow up with sponsor project leads if trackers are not received according to agreed schedule
Periodically run FOCUS reports and follow up with sponsor project lead to ensure errors are corrected and updates are made
Reference Data Updates - create and/or update accounts, contacts, addresses as needed for study site creation or cleanup
Review data coming into the system from outside sources and take appropriate action as required to ensure reference data is clean and accurate
Review data for duplicate entries and take appropriate action to remediate duplicates in reference data
Data Entry Support for Outsourced Studies - create countries and/or sites, enter milestones and enrollment information for outsourced studies
Make updates as trackers are received throughout the course of the study
Follow up with sponsor project leads if trackers are not received according to agreed schedule
Periodically run FOCUS reports and follow up with sponsor project lead to ensure errors are corrected and updates are made
Provisioning Support for SIP Studies - assign external system provisioning roles to site contacts created in SPECTRUM through SIP integration
Periodically run reports and follow up on missing/incorrect provisioning values
Protocol Level Updates - provide support updating trial level information (study team history, protocol level accounts, etc.) as requested by the study teams
Data Setup for UAT - create and/or modify data in non-production environments as requested in preparation for the execution of test scripts
Ad-hoc CTMS Cleanup Activities - perform manual updates in the system that result from data reviews, cleanup campaigns and periodic monitoring activities
Run periodic reports as needed and take appropriate actions to clean/modify identified data issues
Monitor and resolve SPECTRUM/CORE/Exostar discrepancies that impact automated provisioning process
For all tasks if there are any discrepancies in the information provided the CTMS DE team member will reach out to the requester, management or reference aids provided to rectify the discrepancy.
Senior Clinical Data Coordinator, BEO SIP Specialist
ICON
10.2022 - 07.2023
Support UAT activities using ALM system
Support Dry run and Data Set-up of Test Cases
Create User Acceptance Testing (UAT) scripts for systems supported by Business Enablement Operations (BEO)
Ensure in-depth understanding of requirements specifications associated to the system to support test script authoring
Complete required training for ALM, MIDAS CDS and Remedy systems
Complete required System Development Life Cycle (SDLC) training and gain understanding of related SOPs.
Clinical Data Coordinator
ICON
11.2018 - 10.2022
Data Entry Support for SIP Studies/Sites - make updates in SIP as provided on SIP ISIF forms and SIP ISI change forms
Create new/update existing reference data as needed
Enter site accounts and site contacts
Make updates as requested throughout the course of the study
Data Entry Support for Non-SIP Studies/Sites - make updates in CTMS as provided on pre-validated site lists, ISIF forms, ISI change forms, and change requests received via email
Review reference data to see if required account/contact/address records already exist in the system
Create new/update existing reference data as needed
Create sites, enter site accounts and addresses, enter site contacts and addresses, assigned required external system provisioning roles, Make updates as requested throughout the course of the study
Protocol Level Updates - provide support updating trial level information (study team history, protocol level accounts, etc.) as requested by the study teams
Reference Data Updates - create and/or update accounts, contacts, addresses as needed for study site creation or cleanup
Review data coming into the system from outside sources and take appropriate action as required to ensure reference data is clean and accurate
Review data for duplicate entries and take appropriate action to remediate duplicates in reference data
Ad-hoc CTMS Cleanup Activities - perform manual updates in the system that result from data reviews, cleanup campaigns and periodic monitoring activities
Run periodic reports as needed and take appropriate actions to clean/modify identified data issues
Monitor and resolve SPECTRUM/CORE/Exostar discrepancies that impact automated provisioning process
For all tasks if there are any discrepancies in the information provided the CTMS DE team member will reach out to the requester, management or reference aids provided to rectify the discrepancy
Provisioning Support for SIP Studies - assign external system provisioning roles to site contacts created in SPECTRUM through SIP integration
Periodically run reports and follow up on missing/incorrect provisioning values
Data Entry Support for Acquired Studies - create countries and/or sites, enter milestones and enrollment information for acquired studies
Make updates as trackers are received throughout the course of the study
Follow up with sponsor project leads if trackers are not received according to agreed schedule
Periodically run FOCUS reports and follow up with sponsor project lead to ensure errors are corrected and updates are made
Data Setup for UAT - create and/or modify data in non-production environments as requested in preparation for the execution of test scripts
Data Entry Support for Outsourced Studies - create countries and/or sites, enter milestones and enrollment information for outsourced studies
Make updates as trackers are received throughout the course of the study
Follow up with sponsor project leads if trackers are not received according to agreed schedule
Periodically run FOCUS reports and follow up with sponsor project lead to ensure errors are corrected and updates are made.
Safety Assistant 1
ICON
02.2017 - 10.2018
Adhered to company policies and procedures including corporate guidelines and best practices
Responded to staff requests for administrative support as needed
Ran reports from internal systems (e.g
InfoView) and distributed them to the project team or departmental managers
Tracked status in safety systems (Safety Letter Tracker System, Safety Case Tracker, Safety Database, etc.)
Maintained project specific address data for courier applications
Prepared courier shipments (including printing of address labels and copying of attachments)
Reviewed query aging reports and initiated reminders or escalations of queries
Processed safety related documents in eTMF workflows
Received incoming reports for the department (including but not limited to documents received via fax server and safety email inboxes) and distributed the reports to the appropriate project teams
Sent reports/submissions/queries via fax or email
Answered phones and forwarded calls to the appropriate project team member
Participated in the translation management process as assigned
Assisted in the quality control of paper and electronic files
Scanned documents into the electronic Trial Master File (eTMF)
Scanned received documents for unrequested personal identifiers and initiated appropriate actions to protect data privacy.
Customer Service Associate
Upper Dublin Bagel Squad
11.2016 - 02.2017
Stocked all necessary items as needed to ensure efficiency
Completed all monetary transactions via the register and credit card machine
Assisted customers with their bagel selections
Provided excellent customer service while taking customer orders over the phone and in store.
Customer Service Associate
Philly Soft Pretzel Factory
10.2016 - 02.2017
Provided excellent customer service while taking customer orders over the phone and in store
Worked in the production of pretzels via mixing, twisting and checking for accuracy of the dough
Stocked all necessary items as needed to ensure efficiency
Completed all monetary transactions via the register and credit card machine
Assisted customers with their pretzel selections.
Customer Service Representative
Dreamline Shower Doors
05.2016 - 08.2016
Provided world class customer service to dealers, customers, installers and freight companies via telephone, email and fax
Managed difficult customer situations promptly and efficiently.
Patient Care Specialist
Philidor Rx Services, LLC
02.2015 - 01.2016
Managed difficult and/or emotional customer situations in a prompt manner
Serviced existing account, obtained orders, and determined charges for requested products
Provided an exceptional level of customer service while performing prescription intakes, as a call center customer service representative
Maintained correct and comprehensive documentation of all queries, in order to continuously improve the customer experience
Collected customer demographics and accurately entered the information into multiple computer-based applications
Demonstrated compassion and professionalism, while obtaining patient demographics and personal health information
Solicited customer feedback in order to improve the overall experience
Established and maintained professional rapport with patients, which matched the high level of service provided by the pharmacy
Answered inbound and placed outbound calls to patients, regarding their prescriptions.
Night Baker
Giant Food Stores
03.2013 - 03.2015
Baked and prepared all bakery products, displayed in organized case for sales
Coordinated bakery donations to local charities and organizations
Maintained inventory by checking for dated products on the shelves
Provided excellent customer service while taking special orders over the phone and in person.
Facilities Coordinator/Event Planner
Cheltenham Township
08.2001 - 03.2014
Collaborated with various vendors to manage all aspects of the event
Ran two rental facilities for the Township which hosted business functions, parties and weddingsincluding those outdoors at Curtis Arboretum
Drew up all contracts necessary for all events and ensured that they were followed
Performed any other duty that was required to make the event meet the client's expectations
Worked with clients on a daily basis via phone, email and appointments to make sure every detail was covered before their event.
Education
High School Diploma -
Gettysburg Senior High School
Gettysburg, PA
Bachelor's in Elementary Education -
Shippensburg University
Shippensburg, PA
Skills
Electronic Data Capture
Adverse event reporting
Data Collection
Patient confidentiality
Informed Consent
System Experience
Safety ARGUS
TMF NextDocs ETMF
Veeva Vault ETMF
Clinical Trial Management System
Shared Investigator Platfom
Languages Fluency
English
Personal Information
Title: Clinical Data Coordinator
Timeline
Clinical Data Coordinator
ICON
08.2023 - Current
Senior Clinical Data Coordinator, BEO SIP Specialist