Clinical data coordinator Resume

OBJECTIVE:

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

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

TECHNICAL SKILLS

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

PROFESSIONAL EXPERIENCE

Confidential

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

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

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

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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