Open to opportunities

Alexis Archer

@alexisarcher

Message

I lead complex multi-site clinical trials from feasibility through close-out.

United States

Message

What I'm looking for

I'm looking to lead complex, FDA-regulated clinical trials with strong cross-functional teams, sponsor and investigator partnerships, and opportunities to improve activation, quality, compliance, and operational delivery.

I'm currently directing clinical research operations at U.S. Renal Care across multiple FDA-regulated trials, overseeing strategic execution, resource allocation, quality initiatives, and GCP compliance. I also lead hiring, training, performance management, and retention for Clinical Research Coordinators.

At Johns Hopkins School of Medicine, I managed a national portfolio across 50+ U.S. hospitals and research institutions, leading start-up and activation for 150+ Phase I–IV sites. I partnered across Clinical Operations, Regulatory Affairs, Data Management, Quality Assurance, sponsors, and vendors to reduce start-up delays and improve data quality and operational efficiency.

I've delivered multi-site psychiatric trials at Princeton Medical and Yanuvia, managing site activation, feasibility, vendor partnerships, risk mitigation, and budgets ranging from $12M+ to $25M+. Across my work, I have activated and overseen 300+ sites and helped reduce activation timelines, startup costs, protocol deviations, and budget variance.

My clinical research foundation includes oncology, hemophilia, pediatric cardiology, Phase I, and quality-assurance work at the University of Miami Hospital, Syneos Health, Nicklaus Children's Hospital, Florida International University, and Louisiana State University. I bring hands-on experience with regulatory documentation, audit readiness, safety reporting, EDC workflows, study planning, and cross-functional trial delivery.

Experience

Work history, roles, and key accomplishments

Current

Manager, Clinical Research

Current

U.S. Renal Care

Mar 2026 - Present (6 months)

Directed end-to-end clinical research operations across multiple FDA-regulated trials, driving strategic execution, resource allocation, and adherence to FDA and GCP standards. Led full-cycle talent management for Clinical Research Coordinators and strengthened partnerships with investigators and sponsors.

Clinical Research FDA Regulations GCP Talent Management Cross Functional Collaboration Quality Assurance Compliance Patient Recruitment

Clinical Trial Project Manager

Johns Hopkins SOM

Feb 2023 - Mar 2026 (3 years 1 month)

Oversaw a national portfolio of clinical trials across 50+ U.S. hospitals, leading study start-up and activation for 150+ sites. Drove cross-functional execution and served as primary sponsor and vendor liaison, managing multi-vendor teams and budgets.

Clinical Trial Management Site Activation EDC ECRF SOP Development Vendor Management Budget Management Cross functional Leadership

Clinical Trial Project Manager

Princeton Medical

Jan 2022 - Feb 2023 (1 year 1 month)

Led end-to-end execution of multi-site psychiatric clinical trials, activating 40+ sites and meeting 95%+ enrollment targets. Directed site feasibility, vendor management, and budget oversight while maintaining audit-ready compliance.

Clinical Trial Management Site Activation Vendor Management Budget Management Regulatory Compliance ETMF Risk Mitigation

Clinical Trial Project Manager

Yanuvia

Oct 2021 - Jan 2022 (3 months)

Planned and executed clinical trials in accordance with SOPs, managing 4 concurrent studies and delivering 95%+ of milestones on schedule. Served as primary point of contact for CROs, 40+ sites, and vendors, implementing risk mitigation strategies.

Clinical Trial Management SOPs Vendor Management Risk Mitigation Budget Management Cross functional Leadership

Lead Clinical Research Coordinator

University of Miami Hospital

Oct 2019 - Sep 2021 (1 year 11 months)

Managed clinical research data workflows for oncology and hemophilia trials, ensuring timely EDC entry and protocol alignment. Coordinated SIVs, monitoring visits, and served as primary liaison between site staff, monitors, and sponsors.

Clinical Research EDC Data Management Site Initiation Monitoring Protocol Adherence Inspection Readiness

Clinical Research Associate I, Phase 1

Syneos Health

Sep 2018 - Oct 2019 (1 year 1 month)

Monitored safety of subjects in inpatient Phase I studies, identifying and escalating adverse events per protocol. Reviewed IP release, supported drug dispensing, and maintained PK/PD sampling schedules and sample documentation.

Phase I Clinical Trials Safety Monitoring Adverse Event Reporting PK Sampling GCP Source Documents

Lead Clinical Research Coordinator

Nicklaus Children's Hospital

Mar 2017 - Aug 2018 (1 year 5 months)

Coordinated pediatric and NICU cardiology clinical trials, supporting study start-up, recruitment, and protocol execution. Performed clinical procedures and led monitoring and compliance activities including source data review and AE/SAE reporting.

Clinical Trials Study Start Up Recruitment Informed Consent Forms ECG Source Data Review (SDR)AE SAE Reporting ICH GCP FDA Regulations

Clinical Research Associate (QA)

Florida International University, CCF

Jan 2016 - Mar 2017 (1 year 2 months)

Conducted source data verification, internal audits, and TMF reviews to ensure data accuracy and inspection readiness. Monitored data entry in REDCap and Excel, collaborating with PIs and site teams to resolve queries and support audits.

Source Documentation Verification (SDV)Internal Audit TMF REDCap Excel Quality Assurance ICH GCP SOPs

Research Assistant

Louisiana State University

Aug 2015 - Jan 2016 (5 months)

Supported early-phase pediatric clinical trial design for ADHD therapies, contributing to feasibility, timelines, and study planning. Contributed to protocol development and prepared IRB submissions and study instruments.

Clinical Trial Design Protocol Development IRB Submission literature review Neuropharmacology Study Planning

Research Assistant

Psychiatry Private Practice

Jan 2012 - Jul 2015 (3 years 6 months)

Administered and scored standardized psychological assessments for pediatric and adult clients under supervision. Managed confidential patient records and documentation workflows, ensuring compliance with clinical standards.

Psychological Assessment patient records Documentation Clinical Standards Collaboration