Patricia K. Lewis

Chapel Hill, NC 919-***-**** ade7xj@r.postjobfree.com linkedin.com/in/patriciaklewis

Research Associate

Effective team player with strong research and interpersonal skills. Proven leader in project coordination for research efforts, including budgeting, SOP/Guidance compliance, and documentation. Strong ability to coordinate efforts with key internal and external partners, communicating clearly to meet stringent timelines.

Areas of Expertise & Technical Skills

Quality Control

Study Management

Results Tracking

Reporting & Analysis

Vendor Management

International Site Partnership

Data Verification

Process Improvement

Invoicing & Payments

Compliance & Regulations

Database Management

Process Documentation

Professional Experience

RHO, INC., Durham, NC 2001 - Present

Research Associate, Project Coordinator / Assistant

Forged strong partnerships with cross-functional teams and clients. Collaborated with internal and external partners to achieve goals, including study leadership to present study results. Consistently met deadlines for key projects and collaborative initiatives. Administered quality control review of project deliverables.

Key Positions:

Research Associate, Coagulation Disorders Research (Hemophilia A, Hemophilia B, vonWillebrand Disease, Hypoplasminogenemia)

Partnered with international sites to coordinate budget, implementation strategy, and supplies.

Monitored reimbursements and grant payments for projects up to $16M.

Co-designed study management tools to track contacts, subject enrollment, supply inventory and distribution, and case report form inventory.

Orchestrated sample shipments and invoicing for frozen and ambient blood and urine samples.

Tracked study results and progress; developed presentation of information to the Executive Steering Committee and Investigators Meetings.

Supervised project vendors, including laboratories, venues, printing, & shipping.

Batched physical case report forms, managed subject data folders, & performed data entry.

Coordinated internal/external meetings, assisted with meeting minutes, investigator payments, paper TMF

Worked closely with PIs and site staff in the handling of 1572s, CRFs, ICFs etc.

Facilitated resolution of data problems and study closure.

Project Coordinator / Assistant, Biostatistics Department, Project Management Group, Coagulation Disorders Research

Authored and maintained project tracker. Ensured standard forms completion for quality control process.

Administered and established project directories and databases.

Tracked project cost reporting.

Verified project compliance with standard operating procedures, federal law, & ICH/Good Clinical Practices Guidelines. Managed timeline adherence for Observational Studies.

Scheduled meetings, ordered supplies, transcribed minutes, & coordinated work flow.

Education & Associations

Courses included Biology, Microbiology, Anatomy & Physiology

Durham Technical College, Durham, NC

Liberal Arts

Middlesex College, Bedford, MA

Contact this candidate