SUMMARY:

To obtain a position where I can utilize my medical expertise, experience, knowledge and personal attention to detail while identifying key clinical findings and monitoring procedures for the collection of data that is mandated by established policy.

TECHNOLOGIES:

MS Office Support (Word, WordPerfect); ACCESS

WORK EXPERIENCE:

Confidential, Bethesda, MD

Clinical Data Manager | Clinical Data Analyst

Responsibilities:

• Performing Monitoring duties with 8 CRAs (Clinical Research Associates) for Phase I, II & III Oncology & Medical Device clinical trials, Data Management, identifying & resolving CRF & database errors & inconsistencies, database cleaning, Data Analysis, Electronic Data Capture (EDC), eCRFs, Data Extraction & Archiving, Database Quality Control Validation checks, Discrepancies, Reconciliation, Query resolution, Protocol review, Regulatory compliance - Title 21 CFR part 11, CRF completion/Data Entry Guidelines development, Maintaining ISF (& TMF) Investigator Site File (IRB submissions, Protocol/ICF amendments, collecting CLIA certificates & Laboratory normal ranges, licensure, protocol deviations)
• Pharmacovigilance & Safety Surveillance duties: SAE | AE reporting (including potentially serious events & clinically significant information: detection, assessment, collection), safety reporting (supporting Medical Device Regulatory compliance & reporting to Confidential ), SAE data collection to support development of aggregate Safety Reports & Periodic Safety Update Reports (PSUR), Safety Data review, support safety database maintenance, reconciliation of safety & clinical databases, SAE reconciliation, Medical Coding (Diagnosis, AE, Medication) - ICD-9 | ICD-10 | MedDRA | Common Terminology Criteria for Adverse Events - Confidential v3.0, AE Grading, Concomitant Medication coding & reporting (conmeds)
• Operating Clinical Trial Data Management Systems ( Confidential ) | CTMS (Clinical Trial Management Systems) | Relational Database Management Systems (RDBMS):

Confidential

Responsibilities:

• Basic use of SAS feature within Confidential to run & modify custom reports to expedite review of large sets of data, Microsoft Access & Excel 2007/2010: data manipulation | Analysis | Import | Export | database system preparation, Query creation | writing, creating tables, procedure writing, report generation & documentation, Archiving: Microsoft Outlook
• Working cross-functionally with IT, DCRI (Department of Clinical Research Informatics) & Medical Records Dept., Maintaining TMF & eTMF system (Electronic Trial Master File), Developing & Maintaining Study Specific Document Tracking Logs, Organizing | Updating & Maintaining highly-sensitive Clinical Research binders & source documents, Participating in daily Project meetings (& Sponsor meetings)
• Supporting adherence to GMP & ISO standards, validation of batch records documentation (including recalls); all in accordance with Confidential, per Confidential regulations. Patient-Level Data

Confidential, Germantown, MD

Clinical Data Manager

Responsibilities:

• Ensure accurate and consistent management of clinical trial data according to Good Clinical Practice ( Confidential ).
• Ensure regulatory-quality data by managing data activities and processes such as completeness and accuracy of data.
• Effectively manage, monitor clinical study sites and provided in-house site management by communicating with project managers, CRA and other various staff on a regular basis.
• Responsible to design and develop case report forms for multiple clinical trials (in Adherence to Protocol specifications), write CRF instructions and SOPs, create and maintain data management plans, and write edit specification checks.
• Coordinate research studies working equivalently with CRAs to create timelines, resolving queries, reviewing source documentation, monitoring plans.
• Oversee the development and design of specific research and clinical trial databases working equivalently with SAS programmers and data system operation staff.

Confidential, Bethesda, MD

Clinical Data Manager

Responsibilities:

• Lead Clinical Data Manager for Lymphoma Branch of the National Cancer Institute.
• Responsible for managing the data integrity for 6 oncology research protocols
• Provide accurate data abstraction
• Responsible for entering, submitting, and editing data in Oracle Clinical database, ensuring that the sponsors would retrieve quality data
• Responsible to design electronic paper case report forms, standard instructions and
• SOPs, maintain data management plans, and maintained edit specification checks via programmers.
• Ensure that the research team maintains Confidential standards; follow all protocol policy, and IRB regulations.
• Responsible for ensuring that OC database systems correlate with paper CRFs and protocol regulation.

Confidential, Columbia, MD

Abstractor

Responsibilities:

• Able to identify medical/clinical information to be abstracted in medical records.
• Abstracts medical record information into the MQIS and MDE Data Collection Systems using a personal computer
• Proofs medical record information to ensure accuracy.
• Abstracts data in accordance to module specific federal guidelines.
• Tasked with the ability to work independently with little supervision.
• Skilled in the interpretation and application of written guidelines, precedents and work practices standardized - work situations or specific cases.
• Skilled in recognizing non-standard situations and preparing recommendations for problem resolution.
• Knowledge of medical terminology sufficient to be able to analyze clinical findings and prepare abstracts.
• Tasked with analyzing, collecting, organizing and recording data to develop accurate information.
• Skilled in writing clearly expressing ideas and facts and utilizing good grammatical form.
• Assists with data quality control studies to ensure the validity of the database
• Communicates with medical staff and house staff officers to clarify documentation in medical records.

Confidential, Baltimore, MD

Staff Confidential Nurse

Responsibilities:

• Monitored clinical flow of department operations
• Assisted patients with intake
• Scheduled abnormal lab follow up
• Implemented STD and contraceptive counseling
• Directly assisted physicians with procedures, implantation and execution of plan of care.
• Organized colposcopy clinic
• Held patient counseling for abnormal pap smears
• Tasked as nurse for adolescent clinic whose duties entailed above counseling.