Summary
Overview
Work History
Education
Skills
Accomplishments
Certification
Timeline
Generic

NICOLE WATKINS

Wake Forest,NC

Summary

Medical communications professional with strong editorial skills and commitment to accuracy and clarity. Adept at collaborating with teams to deliver precise, high-quality content while adapting to evolving needs. Known for attention to detail, exceptional grammar, proficiency in medical terminology, and ability to meet tight deadlines. Reliable and results-driven, ensuring all projects align with industry standards and client expectations.

Overview

6
6
years of professional experience
1
1
Certification

Work History

Senior Medical Editor/Writer

Apellis/Eli-Lilly
09.2020 - 02.2024
  • Conducted Quality Control/Edits for clinical trial documents i.e. Statistical Analysis Plans, Study Protocols, BUPs, Charters, for scientific language usage, flow, and clarity prior to FDA approval.
  • Collaborated with authors to incorporate revisions, resulting in improved manuscript quality and adherence to guidelines.
  • Reduced awkward phrasing, biased language, and jargon that is inappropriate for research documents and/or journals.
  • Lead QCer responsible for quality review of Clinical Study Protocols for data alignment and quality assurance.
  • Formatted text to comply with medical journal guidelines.
  • Suggested improvements to content to enhance quality and accuracy.
  • Provided training and support to junior Editors and site staff on regulatory documents, procedures, and regulatory requirements for deliverables.
  • Patient Narratives Tirzepatide Team who won the 2021 Lilly-Syneos Health Engagement Award.
  • Established rapport with key clients through proactive communication, fostering long-term relationships built on trust and mutual respect.

Part-Time Clinical Research Coordinator

Capt. James Lovell Veterans Hospital and Hines Veterans Hospital
02.2018 - 09.2021
  • Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
  • Assessed patients'' eligibility criteria following strict adherence to inclusion/exclusion guidelines.
  • Obtained informed consent from study participants in Organ Procurement studies adhering to ethical and regulatory guidelines.
  • Contributed to implementing study-specific monitoring and reporting procedures, methods, guidelines, and tools.
  • Ensured strict adherence to GCP and IRB compliance throughout study lifecycle.
  • Participated in establishing baseline parameters and developing subject-tracking systems for Pharmacogenomics program.
  • Managed and maintained Pharmacogenomics program for Veterans, ensuring all clinical aspects complied with state and federal regulations, guidelines, and policies.
  • Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
  • Facilitated clear communication between principal investigators, sponsors, and study participants for seamless trial execution.
  • Utilized CPRS for patient data management and study-related activities.
  • Provided data management support for tracking patient recruitment activities.

Education

M.S. - Clinical Research Administration

MCPHS School of Pharmacy
Boston, MA

M.S. - Educational Leadership

Concordia University
River Forest, IL

M.S. - Education

Roosevelt University
Chicago, IL

B.S. - Biology

University of Illinois at Urbana-Champaign
Urbana, IL

Skills

  • Regulatory Compliance & GCP: In-depth knowledge and application of GCP/ICH guidelines, FDA and other regulatory requirements, Site Regulatory Documentation (Collection, Review, Submission to TMF), Informed Consent Process
  • Site Relationship Management: Building and maintaining strong collaborative relationships with investigators and site staff, Effective Communication (Oral & Written), Training and Support for Site Personnel, Negotiation Skills, Conflict Resolution
  • Data Management & Systems: Electronic Data Capture (EDC) systems (iMedidata, Medidata RAVE), Clinical Trial Management Systems (Oracle CTMS), Electronic Trial Master File (eTMF/Veeva Vault),
  • Essential Skills: Critical Thinking, Root Cause Analysis, Problem-Solving, Time Management, Leadership, Teamwork & Collaboration, Report Writing, Presentation Skills, Attention to Detail, Quality Control,Medical terminology expertise, Proofreading proficiency, Content organization

Accomplishments

  • Collaborated with Patient Narratives Tirzepatide Team who won the 2021 Lilly-Syneos Health Engagement Award.

Certification

F-IAOCR International Accreditation K-12 Science Certifications Type 75 Administrative

Timeline

Senior Medical Editor/Writer

Apellis/Eli-Lilly
09.2020 - 02.2024

Part-Time Clinical Research Coordinator

Capt. James Lovell Veterans Hospital and Hines Veterans Hospital
02.2018 - 09.2021

M.S. - Educational Leadership

Concordia University

M.S. - Education

Roosevelt University

B.S. - Biology

University of Illinois at Urbana-Champaign

M.S. - Clinical Research Administration

MCPHS School of Pharmacy

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