Research Coordinator - Evidence Generation

Naveris•Waltham, MA

2d•$65,000 - $90,000•Remote

About The Position

Naveris, a commercial stage, precision oncology diagnostics company, is seeking a Research Coordinator - Evidence Generation to help advance its mission of developing and delivering novel diagnostics that transform cancer detection and improve patient outcomes. The flagship test, NavDx, is a breakthrough blood-based DNA test for HPV cancers. This role will support clinical and translational research in virally driven cancer diagnostics by coordinating collaborative relationships with internal teams and external research partners to execute retrospective and prospective studies. The ideal candidate will have a strong background in clinical research coordination, familiarity with oncology and/or molecular diagnostics, and excellent project management and stakeholder communication skills. Experience with real world evidence (RWE) studies and multi-site research infrastructure is preferred.

Requirements

BA/BS or equivalent experience required.
3–5 years of experience in clinical research coordination.
Oncology or molecular diagnostics background strongly preferred.
Experience coordinating multi-site or cross-institutional research collaborations required.
Experience facilitating data-sharing (DSA / DTA), material transfer, research, and limited data set use agreements.
Prior involvement in observational studies, retrospective chart reviews, or longitudinal real-world data registries a positive.
Experience supporting health economics and outcomes research, health technology assessment, or regulatory evidence packages.
Familiarity with GCP guidelines, 21 CFR Part 11, and HIPAA requirements as applied to clinical research.
Must obtain and maintain GCP certification within 30 days of hire (training provided).

Nice To Haves

MA/MS or MPH in oncology, epidemiology, public health, or a related field strongly preferred.
ACRP (CCRC/CCRA), SOCRA (CCRP), or equivalent certification strongly positive.
CITI training a plus.
Familiarity with the publication process, authorship criteria, and collaborative research agreements.
Excellent project management and stakeholder communication skills.
Strong organizational and multitasking abilities with experience managing concurrent deadlines.
Proficiency with reference management tools (Zotero / EndNote), document collaboration platforms, Salesforce or other CRM, and Microsoft Office Suite.
EHR / medical record abstraction.

Responsibilities

Coordinate regulatory and IRB submissions, amendments, renewals, and study closure activities across multiple concurrent protocols.
Assist participating study sites with regulatory coordination, ensuring complete submissions and facilitating IRB approval processes.
Maintain study-specific regulatory binders and ensure all required documentation is current and audit-ready.
Screen and track study eligibility, enrollment, and follow-up for prospective and longitudinal research cohorts.
Monitor protocol adherence and coordinate study activities across participating sites and departments.
Serve as a primary point of contact for external research collaborators contributing to studies, publications, and the real-world data registry (NAVigate-HPV).
Coordinate the onboarding of new collaborators, including access to tools, templates, systems, and guidelines; maintain documentation of signed agreements and completion of onboarding tasks.
Ensure all collaborators are informed of timelines, data-sharing and other agreements, authorship criteria, and applicable compliance protocols.
Track collaboration activities and provide regular status updates to internal stakeholders on progress and deliverables.
Manage documentation, compliance checklists, and publication records across the portfolio of active research studies.
Collaborate with data scientists and bioinformatics staff to transfer, merge, and format datasets for downstream statistical analysis.
Assist in the design and implementation of data collection instruments, case report forms (CRFs), and databases for prospective studies.
Identify and escalate data discrepancies, source document gaps, or protocol deviations to the principal investigator or senior staff.
Coordinate cross-functional input from internal authors, medical writers, biostatisticians, and external collaborators for manuscript and abstract development.
Manage manuscript submission workflows, including journal formatting, author disclosure forms, and correspondence with editorial offices.
Coordinate with internal and external stakeholders to ensure awareness of publications.
Serve as liaison between clinical sites, laboratory teams, biostatistics, regulatory affairs, and evidence generation functions.
Draft and distribute study newsletters, progress reports, and collaborator communications as needed.