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Quality Control Resume

Overland Park, KS

Committed and results-focused professional founded with great clinical and medical experience. Exhibit strong operational, project-management, and team building skills necessary in implementing cost-effective studies. Expert at problem solving and decision making; capable of providing logical solutions to issues. Highly skilled and successful in combining scientific, laboratory proficiency with technical and interpersonal skills in accomplishing goals.

EDUCATION
Bachelor’s of Science, Genetics

EMPLOYMENT

Confidential- Overland Park, KS
Research Coordinator/Quality Control/Data Entry
August 2012 – November 2012

  • Managed 7 protocols using Oracle for data entry.
  • Integrated and structured company’s Standard Operation Procedures for all active in-patient studies for Real Time Quality Control

Confidential- Shawnee, KS
Document Management Associate 2
June, 2011 – June 2012

  • Maintains Document Security and Integrity
  • Provides working copies to end users
  • Provides secure access to original documents
  • Ensures accurate set-up, maintenance, delivery and archiving of files
  • Ensures Project team compliance to Document Management processes
  • Serves as a resource to Clinical Operations team for data administration of clinical database
  • Ensures investigator, sponsor, vendor, and other contact information is accurate, current, and of high quality through project team communication and quality checks

Safety Data Coordinator (contract position)
February 2011 – June 2011

  • Meddra Coding
  • Leads Developmental and implementation of medical coding in clinical data management
  • Participates in management of individual case safety reports (SAE, AE, Adverse drug reactions)
  • AE/SAE reconciliation and data retrievals from clinical and/or safety databases
  • Generates DCF’s or queries, performs corrections of CRFs
  • Tracks submissions of safety reports to investigators and EC/IRBs in tracking systems

Confidential- Houston, TX
Senior Clinical Research Coordinator
November 2009 – March 2010

Confidential- Houston, TX
Senior Clinical Research Coordinator (Spanish speaking site)
July 2009 – November 2009

  • Expanded professional network and contacts in the Clinical Operations’ field
  • Recruited and enrolled patients into research studies. Screened referrals for potential subjects. Ensured all inclusion and exclusion criteria are met. Obtained informed consent. Recorded and documented case report forms in compliance with study standards
  • Coordinated scheduling of required tests, procedures and admissions required for study implementation. Provided clinical evaluation as required. Ensured patient compliance with study protocol. Monitored patients for safety and adverse events. Established rapport with study subjects and serve as a liaison between physician and patient
  • Captured patient data on CRF and EDC in compliance with study standards. Ensured great data quality and promptness. Monitored and verified drug validity and accountability.
  • Prepared clinical research applications to institutional review board. Coordinated protocol submissions, modifications, reports, and renewals
  • Served as a liaison with study sponsors. Coordinated communications and maintain accurate study-related information for sponsor, prepared status reports, and ensured sponsor protocol requirements are met. Coordinated monitor visits.

Confidential- Houston, TX
Site Start Up Specialist
August 2008 – July 2009

  • Perform Site Start-up (SSU) activities consisting of collection, review and negotiating of all required documentation in support and compliance with project and contractual/budgetary guidelines
  • Worked closely with the Clinical Operational Team by planning and implementing clinical research projects; and evaluating and analyzing clinical data.
  • Liaised with contracts department to obtain CDAs for potential CROs, completed necessary forms for CRO RFPs, reviewed responses, assisted with bid defense and CRO selection activities
  • Collated the documents required for the EC/IRB/HA submissions and sent to the relevant functional representatives according to submission timelines, and tracked accordingly
  • Coordinated site visits made by sponsors, FDA, and or NIH during course and at the close of the study.
  • Coordinated project meeting logistics (meeting rooms, invitations, updates), assisted with agenda setting
  • Site on-call to promote understanding of research programs by providing educational opportunities for physicians, nurses, pharmacists and office personnel.
  • Designed and maintained organizational tools to conduct the research study accurately in compliance with good clinical practice guidelines

Confidential- Overland Park, KS
Clinical Data Coordinator (contract position)
June 2007 – August 2007

  • Efficiently performed data management tasks for assigned clinical study projects; utilized Fortis and Oracle Clinical Database software in organizing and maintaining clinical data
  • Monitored and reviewed discrepancies such as system-generated discrepancies, external data discrepancies, global rulings application, and data listings for manual checks
  • Actively participated in Quintiles cross-functional project team meetings to facilitate better projection for deadlines and meet client’s expectations

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