Tracey Phelps
Chesapeake ,VA
Summary
Highly motivated and result orientated Clinical Research Manager with a proven track record seeking a position within a company that will offer challenges, and that strives to be ahead of the curve. Expert in keeping teams and projects on track while empowering leadership and stringent resource allocation. Offers excellent leadership and decision making abilities. Well experienced in Phase I - IV Clinical Trials across several therapeutic areas. Thorough knowledge of FDA, GCP-ICH principles and guidelines.
Overview
13
13
years of professional experience
1
1
Certification
Work History
Site Manager
Velocity Clinical Research
Portsmouth, Virginia
04.2021 - Current
- Managed daily operations of the site, including staff and contractors.
- Reviewed CRFs for completeness and accuracy before database entry.
- Monitored subject enrollment and tracked dropout details.
- Monitored job progress to ensure quality standards were met.
- Prepared budgets and monitored expenses to stay within allocated limits.
- Assigned tasks and delegated responsibilities among team members.
- Collaborated with vendors for procurement of materials needed for projects.
- Directed site activities to drive smooth operations and achieve quality assurance metrics.
- Monitored patient safety during clinical trials according to established guidelines.
- Provided guidance on Good Clinical Practice regulations and other applicable regulatory standards.
- Coordinated investigator meetings, conference calls, and site initiation visits as needed.
- Collaborated with internal departments such as Regulatory Affairs and Data Management to ensure that all studies were conducted in accordance with ICH-GCP guidelines.
- Facilitated resolution of protocol deviations or violations reported by sites or detected through monitoring activities.
Clinical Research Coordinator
Sentara Hospital
Norfolk, Virginia
10.2011 - 04.2021
- Compiled trial related documents into a master file as required by sponsor or regulatory agency.
- Assisted in the preparation of Institutional Review Board submissions for clinical trials.
- Conducted routine visits to research sites to ensure compliance with protocol requirements.
- Performed patient assessments, collected and analyzed data, and prepared reports.
- Monitored patient safety during clinical trials according to established guidelines.
- Reviewed medical records for accuracy of source documentation prior to database lock.
- Reviewed CRFs for completeness and accuracy before database entry.
- Maintained accurate up-to-date tracking logs for all aspects of clinical research activities including but not limited to adverse events, serious adverse events, concomitant medications, lab results .
- Kept patient care protocols and clinical trial operations in compliance.
- Assessed records of each patient, reviewed databases and checked referrals to locate potential research study participants.
- Collected, processed and delivered specimens from trial participants.
- Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.
- Conducted screening interviews to determine eligibility of possible subjects.
- Educated participants on studies and anticipated outcomes.
Education
Associate of Applied Science - Health Administration
Tidewater Community College
Chesapeake, VASkills
- Project Management
- Quality Control
- Quality Assurance
- Trial oversight
- Patient recruitment strategies
- Site Management
- Good clinical practice
- Patient Safety
- Detailed documentation
- CTMS
- IRB
- EDC
- IVRS
Certification
- Certified Clinical Research Coordinator
- Certified Clinical Medical Assistant
Timeline
Site Manager
Velocity Clinical Research
04.2021 - Current
Clinical Research Coordinator
Sentara Hospital
10.2011 - 04.2021
Associate of Applied Science - Health Administration
Tidewater Community College
- Certified Clinical Research Coordinator
- Certified Clinical Medical Assistant
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