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Research Development Associate Resume Sample


Research Development Associate Resume Sample

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Clinical Research Associate

Detailed-oriented, self-motivated, and high-performing professional, offering extensive years of progressive leadership experience and strong qualifications in developing  clinical and financial operations and strategies in the administration, research and marketing of new and existing drugs across the pharmaceutical and  hospital setting. Demonstrates exceptional leadership and organizational skills. Thrives in both independent and collaborative work environments. Exhibits proven ability in building long-term relationships with all levels of hospital and clinical staff. Achieves significant results related to promoting organizational growth and staff development and securing necessary industry-related designations. Displays proficiency in using Microsoft Office Suite (Word, PowerPoint, Excel and Visio), ARISg, and IMPACT.

Core Competencies

  • Clinical and Post-Marketing Products
  • Regulatory Issues
  • Research and Development
  • Client Relations Management
  • Strategic and Tactical Planning
  • Report Generation
  • Budgeting and Cost Control
  • Data Collection
  • Case Management
  • Contract Administration
  • Market Research

Professional Experiences

XYZ INC | DEERFIELD, IL
Safety Associate, Pharmacovigilance | 2010–Present

  • Perform adverse event collection for domestic and foreign serious adverse events (SAE) in clinical and post-marketed products using MedDRA coding, narrative writing, clinical report forms (CRF), and query resolution as necessary and in compliance with established FDA, EMEA, PMDA, ICH, and GCP regulations, timelines, and rules.
  • Participate in triaging safety reports as part of ARISg database; administer regulatory assessment as well as assign causality and listedness for regulatory reporting purposes.
  • Work collaboratively with the Clinical, Safety, and Medical Affairs teams for individual clinical trial and post-marketing SAE reports.
  • Provide input and assistance in the preparation and generation of periodic reports.
  • Serve as a back-up lead for the day-to-day workflow operations.

UVW LABORATORIES | ABBOTT PARK, IL
Senior Clinical Analyst| 2007–2010

  • Oversaw total study budget costs and forecasting for Phase I to Phase IV studies for the Neuroscience therapeutic area.
  • Prepared and presented monthly updates on clinical trial budgets based on spend, contract changes, reconciliation, and closeouts.
  • Performed reconciliation against the Finance Department’s monthly reports and offered back-up support for immunology, oncology, infectious disease, renal, and metabolic therapeutic areas.
  • Conducted quarterly trend analyses for clinical trials as well as created routine and ad hoc reports to support financial and budget tracking.
  • Functioned as a direct liaison between Neuroscience, Quality Assurance, and IT teams to manage business requirements and system implementation for IMPACT, a computer-based clinical trial management system.
  • Collaborated with medical directors and directors of neuroscience therapeutic area to manage and promote clinical and technical data.
  • Supported and monitored grant programs for post-marketing research between the medical science liaisons (MSL) and physician investigators.
  • Developed and maintained open communication with the European Clinical Organization, US Field Operations, CROs, vendors, and other groups as necessary for information and issue resolution.
  • Maximized the opportunity to review study protocols and participated in investigator meetings as a key contributor.

Senior Medical Safety Analyst| 2005–2007

  • Worked on adverse event collection for domestic and foreign serious adverse events (SAE) in post-marketing safety utilizing MedDRA coding, narrative writing, clinical report forms (CRF), and query resolution as applicable and in agreement with established FDA, ICH, and GCP regulations, timelines, and rules.
  • Served as a team lead for daily case assignments and ensured on-time completion of reports.
  • Provided educational training on adverse event reporting for new sales and marketing employees.

RST COMPANY | LAKE FOREST, IL
Registered Nurse Case Manager| 2003–2005

  • Facilitated the quality, cost-effective case management through patient advocacy, continuum of care, and optimization of outcomes.
  • Utilized management and contract administration for commercial, small, and individual risk groups.
  • Evaluated risk analysis for the Underwriting Team, and negotiated discounts and fees with providers to generate cost savings.

PQRS PHARMACEUTICALS | RALEIGH, NC
Pharmaceutical Sales Representative| 2002–2003

  • Managed the selling and promotion of product lines while developing and maintaining strong business relationships with targeted primary care physicians and specialist physicians.
  • Served as a clinical liaison for all disease state programs as an extension of the pharmaceutical services, interventions, biotech solutions, and managed care concepts.
Earlier Career

MNO Company | Northbrook, IL
     Health Project Manager | 1998–2002
LMN INC | Denver, CO
     Registered Nurse Case Manager | 1995–1998
JKLM Hospital | Denver, CO
     Head Nurse – Medical Surgical Unit | 1994–1995
     Registered Nurse | 1992–1994
St. Mary’s Health Center | Saint Louis, MO
     Registered Nurse | 1991–1992
Clinical Psychologists and Associates | Saint Louis, MO
     Medical Insurance Coordinator| 1990–1991

Education

Master of Business Administration (2010)
ABC UNIVERSITY | ST. LOUIS, MO

Associate of Science in Nursing (1991)
DEF COLLEGE | KIRKWOOD, MO

Bachelors of Science in Business with Concentration in Marketing and Economics (1985)
GHI UNIVERSITY | CHARLESTON, IL

PROFESSIONAL TRAINING

Basic Clinical Research Associate (CRA) Certification (2008)

PROFESSIONAL AFFILIATION

Midwest Pharmacovigilance Network, Steering Committee Member


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