Study Coordinator

Position Title: Study Coordinator

Work Location: Irvine, CA 92612

Assignment Duration: 12 Months

Work Arrangement: Onsite/Part time role

Expected Weekly Hours: Approximately 24-32 hours/week

Expected Schedule: Tuesday-Thursday onsite (9:00 AM - 4:00 PM); Monday & Friday flexible/remote support as needed

Position Summary: The Eye Care Research Center is seeking a project coordinator. This role will support management and operationalization of exploratory and clinical studies conducted at the Eye Care Research Center according to the study protocol, regulatory requirements, and standard operating procedures (SOPs).

Background & Context: The role will support the recruitment, scheduling, and execution of subject visits as well as creation of source documents. The role will collect, enter, and maintain accurate study data, ensuring timely reporting of data to necessary stakeholders. Role works closely with the clinical team and AECRC personnel to support smooth study execution. Project manager will support development, authoring and maintenance of SOPs and work instructions. This role is responsible for data entry, cleaning, and maintenance of test material, inventory, supplies, and equipment.

Key Responsibilities:

* Supports execution of clinical research studies, responsible for overall conduct of clinical studies and operational activities at the site.

* Recruit, screen, enroll, consent study subjects as delegated by investigator(s).

* Perform study specific assessments as delegated by investigator(s).

* Perform data collection. * Maintain AECRC inventory and equipment.

* Support ongoing development and maintenance of standard operating procedures and work instructions for the site, including general AECRC operations processes.

Qualifications & Requirements / Skillset

* Study coordinator experience (preferred); site experience with IRB submissions, data entry, etc.

* Prior study coordinator or clinical trial site experience is strongly preferred.

* Candidates with Clinical Research Coordinator (CRC) experience may align well with the role.

* Experience with:

* Informed consent activities

* EDC data entry

* Patient scheduling

* Patient file management

* Data cleaning

* IRB-related activities

* Clinical research documentation

* Familiarity with ICH guidelines, GCP standards, and clinical research regulatory processes is considered more important than deep ophthalmology expertise.

* Ophthalmic technician certification or ophthalmology assessment experience is considered a plus but is not mandatory.

* Candidates should be comfortable interacting with healthy volunteers and supporting patient-facing clinical research activities.

* Strong organizational and administrative support skills are important due to the coordination-heavy nature of the role.

* Approximately two years of relevant research coordination or clinical site exposure is considered sufficient for the role.

* The position is intended to support a full-time onsite clinic manager rather than function independently as the primary study lead.

* Bachelor's degree (preferred).