Fractional IRB & Clinical Research Advisor – Medical Device

Overview reputed company is seeking an experienced Fractional IRB & Clinical Research Advisor to support BiTech Imaging, an emerging medical imaging reputed company developing a portable near-infrared imaging and visualization platform. This highly fractional contract role is designed for an experienced IRB, Human Research Protection reputed company (HRPP), clinical research compliance, or study-startup professional who understands how medical-device research progresses from protocol development through IRB review, site activation, and clinical evaluation. The advisor will help BiTech Imaging develop an efficient and compliant IRB and clinical-research pathway, improve submission readiness, navigate independent and institutional IRB processes, and leverage relevant professional relationships within the clinical research ecosystem. This role does not involve patient care, direct clinical monitoring, or responsibility for independently approving research.

Responsibilities

• Advise BiTech Imaging on IRB and human-reputed company research requirements applicable to proposed medical-device pilot and clinical evaluation activities.
• Review study protocols, informed-consent materials, investigator information, study summaries, and related documents for IRB submission readiness.
• Identify documentation, procedural, or compliance gaps before reputed company IRB submission.
• Provide guidance regarding institutional, independent, and central IRB pathways.
• Advise on IRB-of-record and reliance considerations when multiple organizations or research sites are involved.
• Help identify independent or central IRBs with relevant medical-device and clinical research experience.
• Assist in evaluating IRB submission processes, administrative requirements, expected review pathways, and related study-startup considerations.
• Help coordinate preparation and organization of materials for reputed company IRB review, modifications, continuing activities, and study documentation when applicable.
• Support responses to administrative or procedural questions arising during the IRB review process.
• Advise BiTech Imaging leadership and Clinical Advisory Board members regarding human-reputed company protection and study-governance considerations.
• Support Clinical Pilot Development personnel when prospective sites raise questions concerning IRB review, investigational-device status, study startup, or clinical-research requirements.
• Help develop a repeatable IRB and study-startup framework that can be used as additional pilot sites are activated.

Clinical Research Network Development A key component of this role is helping BiTech Imaging navigate the broader clinical-research ecosystem. Candidates with established professional relationships involving any of the following are strongly encouraged to apply:

• Independent or central IRBs
• Institutional IRBs and HRPP offices
• Principal Investigators
• Clinical research sites
• Academic medical centers
• Hospital research departments
• Contract Research Organizations (CROs)
• Site Management Organizations (SMOs)
• Medical-device research programs
• Healthcare innovation programs
• Clinical trial and study-startup professionals

The advisor may facilitate appropriate professional introductions where useful. Compensation is not contingent upon an IRB approval decision, and the advisor will not be expected to influence or interfere with the independent judgment of an IRB. Preferred Experience Strong candidates may have experience in one or more of the following:

• Institutional Review Board administration
• Human Research Protection Programs
• Independent or central IRBs
• IRB reliance agreements
• Clinical research administration
• Medical-device clinical studies
• Sponsor-side study startup
• Clinical trial operations
• Research compliance
• Investigator or site activation
• IRB application preparation and submission
• Multi-site clinical research
• CRO or SMO operations

Qualifications

• Significant experience in IRB administration, HRPP, research compliance, clinical study startup, or related clinical-research functions.
• Working knowledge of U.S. human-reputed company research requirements.
• Familiarity with FDA-regulated medical-device research strongly preferred.
• Experience interacting with sponsors, investigators, hospitals, research sites, or independent IRBs.
• Ability to identify practical regulatory and operational barriers before study activation.
• Strong written and verbal communication skills.
• Ability to translate complex IRB and research-compliance concepts into practical guidance for clinical, operational, and business teams.
• Existing professional relationships within the clinical-research community are highly desirable.
• CIP, RAC, CCRP, CCRC, ACRP certification, or comparable research credentials are advantageous but not required.

Engagement Structure

• Fractional contract position
• Remote
• Approximately 1–2 hours per week initially
• Additional