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Clinical Data Coordinator Resume

Overland Park, KS

OBJECTIVE:

To acquire a position in healthcare organization that offers professional growth and development, utilizing my skills from both academic and business sectors.

EXPERIENCE SUMMARY:

  • External data reconciliation, DCF review, data audit and UAT on multiple studies
  • Discrepancy management including discrepancy review, query generation and updating
  • Review CRF/eCRF and Train new team members
  • Run daily Ad - hoc reports to track open/answered queries
  • Enter test data and assist to create test data for data validation
  • Experience working in both EDC and paper based systems for Phase I/II/III studies
  • Therapeutics areas include Neurology, Cardiovascular, Oncology, Orthopedics
  • Contribute in all activities from study startup to database lock
  • Work with SAS programmers, Medical reviewers and Biostatisticians to update listings and resolve data issues
  • Run routine reports to check data quality
  • Familiar with creating and review process of CRF design, edit checks, study protocol and SAE reconciliation
  • Verify that clinical data recorded is complete, accurate and consistent
  • Critical QC Audit /Critical Variable QC as needed
  • Serve in the role of back-up to Data Operations Coordinator (DOC)
  • Efficiently work under tight deadlines and on multiple projects
  • Self-learner and result oriented
  • Effective time management and excellent problem solving skills
  • Effectively work in cross-functional teams and independently
  • Excellent interpersonal, verbal and written communication skills
  • Maintain a high degree of flexibility in a fast-paced study environment
  • Detailed knowledge of clinical trials methodology, medical terminology and ICH/GCP regulations
  • Familiar with Clinical research guidelines, MEDRA and WHOART dictionaries
  • Learned to develop test procedures (IQ/OQ/PQ), test protocols and computer system/instrument validation during MS in Validation and Regulatory affairs
  • Extensive knowledge of Pharmacology and Pharmaceutics
  • Knowledge of FDA and international regulations governing current GCP/GLP/ GAMP and new electronic requirements such as 21 CFR Part 11

SOFTWARE/IT SKILL:

  • Inform 4.6
  • Fortis 2.2
  • Medidata Rave 5.6.2
  • OC-RDC
  • MS office word, excel and power point
  • Microsoft Outlook

RELATED WORK EXPERIENCE:

Confidential, Overland Park, KS

Clinical data coordinator

Responsibilities:

  • Extensive experience working on listings i.e. AE, CM, Dose/IVRS, Diary, ECG, Lab data
  • Reconcile data discrepancies and complete clean-up processes on multiple studies
  • Run macro application on listings
  • Propose new approaches for discrepancy resolution
  • Exercise excellent attention to detail on each assignment

Confidential, Overland Park, KS

Clinical data coordinator

Responsibilities:

  • Review listings, resolve manual and system generated queries
  • Enter test data for listing validation in QC database
  • Assist in creating test data using external data per study requirement
  • Review Ad-Hoc reports, BIOS listings and Exception reports

Confidential, Overland Park, KS

Pharmacy Technician

Responsibilities:

  • Assist pharmacist in patient’s prescription filling process
  • Assist in all third party transactions along with completion of required paperwork
  • Communicate and help customers with their questions and concerns on the phone and in person
  • Multitasking and work with precision and efficiency

Confidential, Hoboken, NJ

Teaching Assistant

Responsibilities:

  • Work accurately on assigned tasks including reviewing quizzes and assignments
  • Assist professor in arranging lectures and exams
  • Provide guidance to students in the program regarding course work, study related assignments and project work

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