Clinical Trial Specialist
New
O
Optain HealthHealthcare
United StatesFull-TimeMiddle
Salary85000 - 125000 USD per year
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Job Details
- Experience
- 2-5 years
- Required Skills
- GCP
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 is preferred
- IRB experience is preferred
- Data management experience is preferred
- Knowledge of 21 CFR and ISO 14155 requirements is preferred
- SOCRA or ACRP certification is preferred
- Strong organizational, communication, and problem-solving skills
Responsibilities
- 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.
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