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Data Entry Clinical Research

Location:
Rockaway, NJ, 07866
Salary:
85000
Posted:
August 02, 2022

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Resume:

DEBRA BERNARDO, RN

** ********* **** *****: 973-***-****

Rockaway, NJ 07866 Email: adrza5@r.postjobfree.com

Healthcare Professional

An innovative and seasoned Registered Nurse/ Pharmaceutical professional with over two decades of clinical research experience including direct pharmaceutical industry experience in Pharmacovigilance and Quality Assurance. Outstanding ability to analyze, write, evaluate and produce detailed reports on a variety of projects including protocols and clinical study reports. Experienced working in Quality with technical complaints/ CAPAA’s. Effective organizational, communication and time management skills . Thorough understanding of key ethical and regulatory issues.

Areas of Expertise

Argus 7.0.5

ICD-9 & CPT Coding Specialist

Oracle- Phase Forward

MedWatch

MedDRA Coding

BLS / ACLS certified

AssisTek

Track Wise

Word, Excel, Outlook

Medidata-Rave

EDC systems proficient

SAP

Professional Experience

Bayer Healthcare, Morristown, NJ 2016-Present

Sr Complaint Coordinator, Quality Assurance, Technical Complaints- Pharmaceuticals

Case Processing, including triage of cases, review of investigations, review of medical evaluations, creation of letters to complainants and 3rd party companies.

Assign appropriate risk classification after review of all relevant case information.

Interfaces with internal/external call centers and complainants as required to obtain complete case information and investigate thoroughly.

Supports internal and external inspections by providing subject matter expertise to department management.

Identifies best practices and continuous improvement recommendations relating to processes, SOP’s, Guidance documents, training and technology.

Continuously monitors assigned products to assess trends and signal detection of a potential quality defect based on market feedback.

Training of new departmental employees on internal complaint possesses, product knowledge and IT systems.

Bayer Healthcare, Whippany, NJ 2013-2016

SAFETY DATA SPECIALIST, PHARMACOVIGILANCE- Consumer Care

Acted as the project lead for a special project, which involved reviewing of all incoming reports to ensure reportability of adverse events

Involved in Bayer/Merck integration process. Facilitated and actively participated in process and database integration and improvement initiative working closely with cross-functional taskforces and committees. Performed new hire QC of off-site associates and provided feedback, when needed

Responsible for managing group emailbox, assigning incoming questions and/or tasks to appropriate individuals/teams

Performed QC of the not routed reports for Onsite and offsite cases on a daily basis and ensured all the reportable cases were routed, so as to adhere to timelines.

Manage Argus safety database work lists according to global database documentation requirements and local Standard Operating Procedures

Review case information received from various sources for accuracy to ensure quality of data entry into global safety database.

Collaborate with Consumer Relations to issue case clarifications and case corrections as needed

Perform triage and MedDRA coding of serious and non-serious Adverse Event Reports according to local Standard Operating Procedures

Prioritize and accurately perform data entry for both serious and non-serious adverse event reports into the Argus safety affiliate database per departmental guidelines.

Monitored, requested and obtained all applicable follow-up information from reporters to ensure completion of case reports within specified timelines as prescribed by global regulations and Standard Operating Procedures

EXODON CLINICAL RESeARCH, Mt. Arlington, NJ 2012 –2013

Clinical Research Nurse/Coordinator

Nursing staff member charged with managing and coordinating clinical research studies.

Managed studies to ensure compliance with study protocols, research objectives, informed consent and institutional guidelines. Collected and prepared study documents, including case report forms, other study related source documents as well as AE/SAE reports.

Managed process associated with safety reporting

Performed study evaluations, controlled medication inventory, dispensed test pharmaceuticals, and assisted investigators in study management.

Forecasted and maintained adequate clinical supplies

Interfaced directly with test subjects informing them about study elements and expectations.

Ensured clinical trials were conducted in accordance with State and Federal regulations, Good Clinical Practice regulations, and internal Standard Operating Procedures

UNIVERSITY OF MEDICINE AND DENTISTRY, Newark, NJ 1996 –2011

Clinical Research Nurse/Coordinator

Nursing staff member charged with managing and coordinating clinical research studies.

Collaborated with principal investigator on Women’s Health Initiative Research to facilitate and coordinate daily clinical trial activities and implementation of study protocols. Performed nursing assessments, monitored subjects, and oriented other research staff to ensure proper compliance with federal regulations and institutional guidelines / code of conduct.

Supervised research samples, records and essential documentation for multiple clinical studies; obtained and processed fluid samples, curated HIPAA records, maintained test subject charts and data sheets.

Briefed test subjects about study elements and expectations.

Maintained adequate and accurate case histories for each study subject and recorded all observations in the source document and on the Case Report Form (CRF) during a study

Consistently reviewed and assured compliance with all applicable Food and Drug Administration (FDA) Federal Regulations, the International Conference on Harmonization (ICH) Guidelines for Good Clinical Practices (GCPs), health system policies, and site and protocol specific requirements.

Designed and maintained organizational tools to conduct the study accurately and in compliance with GCP

Education

Bachelor of Science (in-progress), Perdue Global University, Davenport, IA

Associate Degree Applied Science, County College of Morris, NJ

Licenses

Registered Professional Nurse (license #26NO11881400)

Volunteer Vice Presedent Randolph Board of Health 2011-Present



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