Malcolm Mack

Clinical research operations professional with 10 years of client-facing experience, oncology trial coordination, study startup, site activation, sponsor and CRO liaison experience, and ICH-GCP knowledge.

Coordinated

Phase III/IV studies, supported new study activation through protocol and budget discussions, and maintained IRB, essential-document, safety, and audit-ready files. Additional experience includes multi-site healthcare quality programs, documentation standards, milestone tracking, and cross-functional provider engagement.

Provider Engagement Executive — Quality Program Tracking - Humana - Remote

(2022-01 - 2025-01)

• Managed multi-site quality-programs across 13 health systems covering 80,000 lives in NC, SC, VA, and GA; maintained status, documentation completeness, and audit-ready files.
• Built Power BI and Tableau trackers within Salesforce for milestone, gap, and compliance status across assigned provider networks.
• Supported inspection-style readiness by enforcing documentation standards, verifying data completeness, and executing corrective follow-up across systems.

Practice Performance Consultant — Documentation & Workflow Standards - UnitedHealth Group – Optum - Remote

(2019-01 - 2022-01)

• Implemented documentation and workflow standards in Epic and Athenahealth for physician groups and IPAs, shortening the time-to-complete quality files by about 20%.
• Verified clinical source documentation against program requirements and prepared completed audit packets for business review.
• Coached site clinical staff on file completeness and data integrity without owning a sales calendar.

Quality Practice Advisor — Site File Standards & Audit Education - Wellcare O'hana Health Plan (Centene) - Kapolei, HI

(2018-01 - 2019-01)

• Audited clinic documentation for completeness and regulatory alignment against state, federal, and NCQA requirements; trained sites on file standards.

HEDIS Auditor & Clinical Quality Specialist - UnitedHealthcare Group - Honolulu, HI

(2016-01 - 2018-01)

• Completed clinical data abstraction and quality audits supporting NCQA reviews, CAHPS, and state health audits.
• Served as direct liaison between corporate Quality Management and assigned physician groups for inspection readiness.

Clinical Research Coordinator — Oncology (Lymphoma) - University of Washington / SCCA / Fred Hutchinson Cancer Research Center - Seattle, WA

(2011-01 - 2014-01)

• Coordinated 5 concurrent Phase III oncology clinical trials and 3 Phase IV long-term follow-up studies; enrolled more than 150 patients across 8 active protocols.
• Served as the primary day-to-day liaison among clinic, pharmacy, lab, and sponsor monitors; facilitated cross-functional communication and trained investigators and sub-investigators on new and amended protocols.
• Supported trial feasibility, planning, and site activation for 2 new studies with Gilead and Takeda through direct protocol and budget discussions with CRAs, MSLs, and medical directors; closed out 2 studies.
• Supported more than 50 monitoring visits by preparing source, regulatory, and protocol-adherence materials for PIs, CRAs, and pharmaceutical industry sponsors.
• Reported approximately 15 AEs and 5 SAEs to sponsors and DSMBs; maintained IRB submissions and essential-document binders through regulatory processes, amendments, and continuing review.
• Screened approximately 5 patients per week against protocol inclusion/exclusion criteria and medical terminology to maintain compliance with ICH-GCP and FDA standards.
• Managed CRO and sponsor correspondence, provided trial progress and enrollment updates, documented protocol deviations, and reported serious adverse events (SAEs) in accordance with regulatory and study requirements.

Clinical Associate II — Oncology / Cellular Immunotherapy - Dendreon Corporation - Seattle, WA

(2006-01 - 2010-01)

• Performed immunological cell culture of dendritic cells for antigen loading and presentation in support of sipuleucel-T (Provenge), the first FDA-approved cellular immunotherapy for prostate cancer.
• Authored 4 global production batch records and wrote facility SOPs; participated in mock process runs used to demonstrate GMP manufacturing scope and capability.
• SOPs and batch records directly supported NDA and BLA filings; revised 5 additional SOPs under cGMP and GCP document-control practice.
• Maintained chain-of-identity verification across patient treatment files in CTMS and resolved data discrepancies to prevent treatment delays.
• Supported FDA audits and regulatory correspondence tied to the licensing of a $275M New Jersey production facility.

Master of Science (MSPH) - Public Health - Trident University International (2013-01 - 2013-01)

Bachelor of Science (BS) - Biology - Excelsior College (2010-01 - 2010-01)