Support site start-up activities, including creation of study templates, CRFs, study manuals, site shipments, investigator binders and investigational device accountability.
Support data entry, query tracking, and remote and on-site monitoring needs in collaboration with CRO and internal team members.
Support or lead IRB submissions.
Maintain essential documents in the Trial Master File (TMF) per regulatory and company standards.
Coordinate clinical trial logistics such as meeting scheduling, site communications, and shipping of study materials.
Collaborate with CRO, central reading centers and other vendors as needed.
Draft and distribute study-related communications, agendas, and minutes.
Ensure adherence to GCP, ISO 14155, and regulatory guidelines with supervision.
Assist in the preparation of clinical study reports, presentations, and regulatory submissions.
Contribute to the development of SOPs, templates, and internal workflows.

Requirements

Bachelor’s degree in life sciences, health, or related field.
2-5 years of clinical research experience, preferably in medical devices or diagnostics.
Good Clinical Practice (GCP) certification
Ophthalmology knowledge is preferred. Prior photography and/or imaging experience, IRB experience, and data management experience is also preferred.
Knowledge of 21 CFR and ISO 14155 requirements is preferred.
SOCRA or ACRP certification is preferred.

Benefits

Competitive compensation package, including a strong base salary, performance-based bonus, and the chance to earn upside.
Top-tier health, vision, dental, and commuter benefits.
Generous monthly health and wellness reimbursement.
Unparalleled exposure to new business building at the intersection of artificial intelligence and healthcare.
Mentorship, clinical operations training with increasing exposure to site-facing activities.
A chance to work with a highly talented, close-knit team and dedicated mentors who can guide you on your career path.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical researchdata entryquery trackingmonitoringIRB submissionsTrial Master File (TMF)clinical study reportsSOP developmentstudy templatesinvestigational device accountability

Soft Skills

collaborationcommunicationorganizationleadershipattention to detail

Certifications

Good Clinical Practice (GCP)SOCRA certificationACRP certification