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Overview
BiTechnologies is seeking an experienced Fractional IRB & Clinical Research Advisor to support BiTech Imaging, an emerging medical imaging venture developing a portable near-infrared imaging and visualization platform.
This highly fractional contract role is designed for an experienced IRB, Human Research Protection Program (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-subject 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 formal 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 initial 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-subject 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-subject 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 paid hours may be authorized during active submissions or pilot-site activation
- Starting compensation: $125 per hour
- Initial 12-month engagement
- Work assigned based on actual clinical-development and study-startup needs
Role Boundaries
The advisor will help BiTech Imaging prepare for and navigate independent research review.
The advisor will not be responsible for:
- Guaranteeing IRB approval
- Influencing an IRB’s independent determination
- Providing patient care
- Monitoring individual patient safety data
- Performing phlebotomy or clinical procedures
- Serving as the study’s treating physician
- Managing statistical analysis or clinical trial databases
- Acting as a voting IRB member on a BiTech Imaging study when a conflict of interest exists
About the Opportunity
BiTech Imaging is developing a structured clinical-development model combining physician Clinical Advisory Board input, clinical pilot development, regulatory planning, IRB navigation, and external research-site review.
The selected advisor will help establish a scalable IRB and research-network infrastructure that supports future clinical evaluation and pilot activity.
Compensation
$ 85 – $ 100 per hour
