Diagnostic Technician

• Feb 2021 - Present

● Assist in setting up Packaging lines and staging for production activities. ● Assemble, label, and package final kit for shipment per instructions in applicable SOPs and Production Records. ● As part of the quality control team, I will perform in-process quality checks for specific defects, proper label alignment, and kit inspections to conform to quality standards is applicable SOPs, and applicable ISO and cGMP requirements. ● After Pack operation, count and reconcile intermediates, labels, inserts, and other materials. ● materials. ● Palletize the finished product and will assist in moving finished product from Pack lines to refrigerated and general warehouse areas. ● Assists in completing all documentation such as Production Manufacturing Records and all required forms associated with packaging operations. ● Perform housekeeping duties such as cleaning work area, decontaminating work surfaces, and other tasks following SOPs, QSRs, and safety regulatory requirements. Show less

Customer Care Specialist

• Sep 2019 - Present

Document Retrevial Specialist

• Nov 2017 - Present

Analytical Technician

• Dec 2016 - Present

Clinical Data Coordinator

• Aug 2015 - Present

• Responsibilities included developing CRFs/eCRFs, testing data entry screens and edit checks for studies in ClinPlus and eCaselink.• Worked with RAVE to manage and resolve queries. Alerting the Data Manager on any queries that needed reissuing.• Perform discrepancy management by tracking, reviewing and issuing discrepancies to sites. Manage and follow up on outstanding discrepancies. Resolve all system and manual discrepancies, reissuing as needed.• Support Data Manager by updating/creating the following: Data Management Plan, Edit Spec Document, CRFs/eCRFs, Data Entry Instructions, CRF Completion Guidelines, CRF annotation.• Support Data Manager with database lock activities such as final discrepancy management, database QC, ensuring all documents are finalized and all required signatures are obtained.• Participate in department meetings and provide feedback related to study tasks. Show less

Data Entry Specialist

• Jul 2013 - Jul 2015

• Performed 1st & 2nd pass data entry, CRF tracking and validation of data into ClinPlus & eCaselink database.• Prioritized data entry prioritizing data batches for entry, provide support to staff for data entry related questions.• Managed discrepancy tracking and provided Data Manager with outstanding query list. Issued discrepancies to sites and resolved returned queries.• Performed UAT of edit checks and assisted with database lock QC.

Data Entry Associate (Contract)

• Oct 2011 - Jan 2012

• Developed study CRFs for all studies using InDesign. • Performed 1st & 2nd pass data entry and UAT of entry screens and edit checks in ClinPlus. • Participated in the QC of data for database lock. • Developed study CRFs for all studies using InDesign. • Performed 1st & 2nd pass data entry and UAT of entry screens and edit checks in ClinPlus. • Participated in the QC of data for database lock.

Data Associate II Assist with CRF Annotation

• May 2007 - Sep 2010

• Worked with RAVE and InForm databases to perform discrepancy management by resolving site answered queries and issuing re-queries as needed, reviewed data to freeze designated pages for screen failure subjects. • Performed discrepancy management with non-EDC systems, running/reviewing edit check output, sending queries to sites, and resolving returned queries. Reviewed manual listings and generated/resolved manual queries. • Performed laboratory & PK data reconciliation; UAT of database; assisted with database lock activities such as resolving final edit checks, reviewing subject casebooks for completeness, and final QA of database. • Worked directly with Lead Data Manager and executed CRF annotation, Data Entry Guidelines and Data Management Plan. • Prioritized incoming CRFs for entry; 2nd pass data entry and 1st pass entry if needed; completed verification process after entry to review inconsistencies and validate data into the database. • Assisted and mentored lower-level entry staff on tasks to ensure correct entry of data and compliance of study specific entry guidelines. Show less

Receptionist – Front Desk (part-time)

• Apr 2000 - Jun 2007

• Answered phones and filed charts; entered patient and insurance information into the computer system. • Scheduled appointments; collected and entered patient payment into computer system. • Answered phones and filed charts; entered patient and insurance information into the computer system. • Scheduled appointments; collected and entered patient payment into computer system.

Receptionist (satellite laboratory)

• Apr 1999 - Jun 2000

• Answered phones, greeted patients, entered patient and insurance information into computer system.• Ensured flow of patients was equally distributed between phlebotomist staff.• Entered diagnostic testing into computer system and prepare the specimen collection tubes for each patient and provide that to each phlebotomist.

Administrative Assistant/Human Resources

• Jun 1989 - Apr 1999

• Organized incoming job applications, compiled and maintained listing of open positions, posted in-house openings, placed advertisements for open jobs.• Attended job fairs and conducting new hire orientation and interviewed applicants when needed.• Conducted orientation for all new hire employees.