Research Coordinator

About Us

Would you like to be part of a fast-growing team that believes no one should have to succumb to viral-mediated cancers Naveris a commercial stage precision oncology diagnostics company with facilities in Boston MA and Durham NC is looking for a Research Coordinator - Evidence Generation

to help us advance our mission of developing and delivering novel diagnostics that transform cancer detection and improve patient outcomes. Our flagship test NavDx is a breakthrough blood-based DNA test for HPV cancers clinically proven and already trusted by thousands of physicians and institutions across the U.S.

Opportunity

We are seeking a detail-oriented and proactive Research Coordinator to support clinical and translational research in the field of virally driven cancer diagnostics. This role will be instrumental in coordinating collaborative relationships with internal teams and external research partners to successfully 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.

Job Responsibilities

Study Coordination & IRB Compliance

• 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 as needed.
• 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.

Research Collaborator Coordination

• 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.

Data Management Support

• 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.

Publication & Scientific Output Support

• 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.

Stakeholder Communication & Project Management

• 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.

Requirements

Education

BA/BS or equivalent experience required; MA/MS or MPH in oncology epidemiology public health or a related field strongly preferred.

Experience

• 35 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.

Certifications

• ACRP (CCRC/CCRA) SOCRA (CCRP) or equivalent certification strongly positive; CITI training a plus.
• Must obtain and maintain GCP certification within 30 days of hire (training provided)

Preferred Skills

• 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 and plus.
• EHR / medical record abstraction

Compliance Responsibilities

Health Insurance Portability and Accountability Act (HIPAA) is a federal law that describes the national standards to protect sensitive patient health information from being disclosed without the patients consent or knowledge. All roles at Naveris require compliance with legal and regulatory requirements of HIPAA and acceptance and adherence to all policies and standards at Naveris. Personnel acknowledges they are personally responsible for reporting any suspected violations or abuse and are required to complete HIPAA training when joining the company.

Why Naveris

In addition to our great team and advanced medical technology we offer our employees competitive compensation work/life balance remote work opportunities and more!

Naveris is an Equal Opportunity Employer

Naveris is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We dont just accept differences - we celebrate and support them. We do not discriminate in employment on the basis of race color religion sex (including pregnancy and gender identity) national origin political affiliation sexual orientation marital status disability genetic information age membership in an employee organization retaliation parental status military service or other non-merit factor.

Base Salary Range: $65000 $90000