SUMMARY:

• Pharmaceutical Bioanalytical Scientist with 20+ years’ experience in the management, outsourcing, and coordination of study operations.
• Also, experienced in the regulatory standards and compliance guidelines; GxP, SOP’s and Confidential - GCP.
• Ability to work in a Global Matrix team environment.
• Ability to manage multiple tasks with enthusiasm and prioritize workload with attention to details and budget constraint.
• Excellent interpersonal, verbal and written communication skills.

CORE COMPETENCIES:

• Clinical Studies
• Confidential GCP Guidelines
• GxP Regulatory
• Compliance Data Collection & Entry
• Documentation integrity
• Protocol Knowledge
• Technical Writer
• Computer Systems

TECHNICAL SKILLS:

• Cardiovascular, CNS, Infectious Diseases and Oncology
• Argus, Oracle RDC, EDC, Oracle Clinical CTMS, Microsoft Office

PROFESSIONAL EXPERIENCE:

Confidential, Edison, NJ

Clinical Research Associate Intern

Responsibilities:

• Reviewed Confidential filing documents for accuracy and completeness and submit to Sponsor for site activation into clinical trials.
• Communicated with Principal Investigators and Research Coordinators providing remote monitoring support to ensure site compliance with clinical trial protocol procedures.
• Troubleshoot site issues in accordance with broad understanding of the assigned clinical trial
• Assisted in maintenance of regulatory documentation throughout trials to accurately reflect ongoing activities of participating sites and personnel.
• Collected and tracked regulatory documents for submission to Central and Local IRB and verify IRB approvals.
• Supported clinical monitoring staff for visit preparation, regarding regulatory document tracking and other study file correspondences and ensuring Sites are Inspection ready always.
• Accurately completed and reviewed all study documentation forms including source documents and case report forms in a timely manner; responded to and resolved data queries in conjunction with sponsors.
• Reviewed and reconciled all essential documents of the Trial Master File (TMF) in compliance with SOPs, GCP and Confidential Guidelines.
• Supervised assigned sites to ensure quality and integrity of data by complete source data verification. Reviewed study case report forms (CRFs) completed by the investigative sites and verified entries by validating accurate source documentation to support CRF entries.
• Coordinating the discussions with the site staff about the open queries in the EDC systems and guide the designated staff to answer those questions.
• Collected IRB approval documents from any amended protocol, Informed consent form, Investigator Brochure and any other subject facing material.
• Discussed about open queries in EDC system and guide the site staff to answer those queries.

Confidential, Ewing, NJ

Lead Scientist

Responsibilities:

• In accordance with Confidential ’s Confidential laboratory guidelines in the role of a technical writer completed various study document types to ensure compliance; Final Study Summary, Supplemental Validation Study Close-out Report, Analytical Validation Plan (AP)/amendments, Analytical Methods (AM)/updates and SOP’s deviations.
• Operated in the role of a study coordinator to ensure study accuracy and data integrity of Confidential quantitation results.
• Generated Watson LIMS study design, samples acquisition list, Incurred Sample Repeats (ISR’s) analysis list for laboratory analyst.
• Archival of final study package.

Confidential, Clark, NJ

SPF Coordinator

Responsibilities:

• Tracked and managed documentation activities of regulated Confidential and Confidential testing.
• Requested PO number for scheduled testing and Confidential for payment approval to contract labs.
• Collected information for review/approval of attestation or waiver requests for international registration.
• Reported topline/summary results to testing requestors (scientists).
• Compiled final reports for study close-out in tracking system.

Confidential, East Hanover, NJ

Scientist I - Lab Coordinator

Responsibilities:

• Coordinated and monitored preclinical bioanalytical study assignments at Confidential ’s for scientific integrity, quality, timelines, and budget constraints.
• Ordered and managed drug supply requests for preclinical, clinical, and biologics studies assigned for the Early Bioanalytics Technology (EBT) laboratory.

Investigator

Confidential

Responsibilities:

• Summarized and contributed to pharmacokinetic ( Confidential ) evaluation and interpretation; completed and r eviewed Toxicokinetic Confidential /MS small molecule studies and reports in support of Confidential enabling activities.
• Operated and troubleshoot in a semi-automated Confidential laboratory for sample preparation (Tomtec), sample documentation (electronic laboratory notebook), sample quantitation (Analyst, version 1.6.2), and software systems including Watson Laboratory Inventory Management System (LIMS), WinNonlin, and Waters, NuGenesis, Scientific Data Management System (SDMS).