- Science education within a STEM field (medical / healthcare focus desirable).
- Training or advanced degree in clinical research discipline. Knowledge and/or training in application of digital health solutions.
- Confirmable success in conducting clinical research (both small and large trials).
- Field experience as a clinical research coordinator.
- Involvement with medical device and/or pharmaceutical and/or digital health trials.
- Fluent in English Business communication skills (speaking and writing).
- Flexible with well-developed critical thinking skills.
- Must be comfortable in fast paced, high pressure environment.
- Able to accommodate and adapt to frequent change.
- Understanding of technical medical terminology.
- Comfortable and credible in public speaking with ability to clearly present scientific and clinical data to clinicians, sponsors, and partners.
- Regulations: 5 years (Required)
- Clinical Trials: 5 years (Required)
- Medical Terminology: 5 years (Required)
- Clinical Research: 5 years (Required)
- Strong English necessary if not language of origin.
This position will report to HITLAB Co-leaders, Chairperson and Executive Director.
HITLAB is an innovation and teaching lab dedicated to improving the quality and accessibility of healthcare worldwide. We help leading organizations ideate, create, and evaluate technology-based solutions to pressing healthcare challenges. The RD will have overall ownership of diverse clinical development programs and studies performed by HITLAB on behalf of its various Sponsors. This position will be responsible for, in alignment with each individual Sponsor’s objectives: overseeing investigation design; developing appropriate protocols; gaining IRB approvals; finding, verifying, selecting and contracting with investigators; supervising study operations; monitoring quality for assuring compliance with standards and regulations; achieving defensible results within time and budget targets; etc. This individual will also be accountable for presenting scientific data and findings to sponsors, partners, clinicians, professional groups, etc.
Management of clinical research teams, focusing on driving clinical trials to rapid enrollment and timely completion.
Team responsibilities include:
- Drafting clinical trial protocols, reports, and submissions for publication. Determination of study costs and timing.
- Preparation of trial-related paperwork. o Coordination of sample evaluation with third-party laboratories.
- Data collection and coordination.
- Coordination of test material delivery to investigation sites.
- Reporting of study progress to management.
- Preparation of advertising for recruitment.
- Monitoring of enrollment status.
- Data management and adverse event reporting.
- Creation and monitoring of study timelines.
- Adherence to the HITLAB processes, standards quality management system.
Work closely with other HITLAB senior leaders for business development including planning and forming external, sponsor-facing clinical educational / marketing material, such as publications, conference presentations, symposia, development of scientific advisory boards, etc.
Developing and maintaining relationships with clinical thought-leaders in relevant fields of life sciences, digital health fields and major technology companies with healthcare ambitions.
Oversees all aspects of HITLAB clinical development processes, including establishing appropriate frameworks, tools, SOPs, training materials, etc. for fully “systematizing, “productizing” and “globalizing” HITLAB’s capabilities.