Clinical Research Coordinator (1-year contractor)

Your Role

The Clinical Research Coordinator manages the day-to-day operations of clinical trials at the investigational site under the direction of the Principal Investigator (PI). The SC ensures strict adherence to the protocol, ICH GCP guidelines, and local regulatory requirements, safeguarding subject safety and data integrity.

The role of Clinical Research Coordinator will involve:

• Subject Management & Recruitment

o Assist the PI in identifying, screening, and recruiting eligible trial participants.

o Guide subjects through the Informed Consent Form (ICF) process legally and ethically.

o Schedule patient visits and follow-ups to maintain high subject retention.

• Trial Execution & Administration

o Handle Institutional Review Board (IRB) submissions, amendments, and notifications.

o Maintain and update the Investigator Site File (ISF) to ensure audit readiness.

o Manage trial logistics, including investigational product (IP) accountability and lab speci-men handling.

• Data Management & Compliance

o Abstract data from medical records and perform timely entry into Electronic Data Capture (EDC) systems.

o Apply ALCOA+ principles to guarantee high-quality, verified source documentation.

o Resolve data queries initiated by Clinical Research Associates (CRAs) promptly.

o Assist in processing and reporting Serious Adverse Events (SAEs) within required timelines.

• Stakeholder Coordination

o Act as the primary site contact for sponsors, CROs, and monitoring CRAs.

o Facilitate site monitoring visits, audits, and inspections.

o Coordinate trial logistics across hospital departments (e.g., pharmacy, radiology, central labs).

Your Experience

• Bachelor's degree or above; majors in Nursing, Optometry, Medicine, Biomedical Sciences, Life Sciences, or related fields are preferred.
• Prior experience in clinical trials, medical devices, or ophthalmology-related work is preferred.
• Clinical experience in optometry or ophthalmology is highly desirable.
• Familiarity with visual acuity testing and refraction procedures is preferred.
• Experience with ophthalmic diagnostic examinations, including corneal topography, axial length (AL), and pachymetry measurements, is preferred.
• Experience in subject recruitment, coordination, data collection, and follow-up activities.

It would be desirable if you had

• Ability to assist with Case Report Forms (CRF), electronic CRFs (eCRF), and study data management.
• Proficient in Microsoft Office applications (Excel, Word, and PowerPoint).
• Ability to read and understand English research protocols, SOPs, and related documentation.
• Prior participation in medical device clinical trials will be considered a strong advantage.

Apply now to take the next step in joining ZEISS, where you can push technological boundaries, shape markets and contribute to the advancement of society.