Clinical Trial Assistant - Nicox Ophthalmics, Inc.

THE COMPANY

Nicox is an international ophthalmology company developing innovative therapeutics to help maintain 
vision and improve ocular health.

We are maximizing value by advancing our product candidates through clinical development to approval in the U.S. and EU markets, optimizing their development and commercialization in the rest of the world through partnerships, and potentially expanding our pipeline with new internal 
research and development projects, in-licensing, or acquisitions of ophthalmic development candidates or approved products.

JOB OVERVIEW

The Clinical Trial Assistant assists the Clinical Development team in the coordination of assigned clinical operation activities to ensure that ongoing and upcoming clinical trials are completed on time and within budget. The position also extends support to the Project Management department and Chemistry and Manufacturing Controls (CMC) organization for activities as requested.

The assigned clinical programs may include all stages of development (from Phase 1 to Phase 4) in the areas of Glaucoma, Dry Eye, and other ophthalmic conditions.

ESSENTIAL FUNCTIONS

•  Assists the clinical team in preparation, handling, distribution, filing, and archiving of clinical documentation and reports.
•  Assists the clinical team with site follow-up of documents and reports.
•  Assists with accurately updating and maintaining clinical systems that track compliance and 
performance within project timelines according to ICH-GCP and local regulations.
•  Provides clinical study start-up expertise and support, including but not limited to essential 
document collection and IRB submissions.

• Collaborates with external vendors and partners, to include the following activities:

• Reviews CRO project-related documents.
•  Participates in ongoing review of study data with a focus on protocol deviations and safety events.
• Participates in Nicox-CRO(s) teleconferences/meetings.
•  Liaises with vendors participating in the program(s).
•  Tracks study progress, invoices, and other project management tasks.
•  Attends and assists with Investigator Meetings as needed for selected topics/activities.
•  Escalates issues to the Study Manager, Director of Clinical Operations, and/or VP of Clinical Development, as appropriate.

•  Organizes in-house portions of clinical studies including, but not limited to:

•  Tracks study progress, payments, and other project tasks.
• Assists with information flow/communication with all relevant groups to ensure the smooth running of the projects.
• Assists the CRO clinical team and field CRAs with project-related activities.
• Assists with the preparation, review, and distribution of study correspondence.
• Acts as a point of contact for clinical site questions and support requests and escalates as 
  appropriate.

QUALIFICATIONS

•  B.S. or B.A. or five (5) plus years in Clinical Research preferably in Ophthalmology.
•  Certified training in GCP.
•  Strong interpersonal, organizational, time management, and communication (verbal and written) 
skills in English (Spanish is a plus)
•  Experience with various study systems (EDC, IRT, IRB portals, eTMF, CTMS, etc.) used in clinical 
trials.
•  Advanced proficiency in Microsoft Office Programs (Outlook, Excel, PowerPoint, etc.).

To be successful in this role, the candidate needs to ensure the project meets the corporate goals on time. Top candidates are proficient multi-taskers with an ability to prioritize tasks.

BENEFITS OVERVIEW

• Company-paid premiums for medical, dental, vision, long-term disability, short-term disability, and life/accidental insurance.
• 401(k) plan with 4% yearly company contribution
• Employee Assistance Program
• End of year Company-wide shutdown
• Paid vacation time off
• Paid personal time off
• Paid parental leave
• 11 paid holidays

“Nicox is committed to encouraging equality and inclusion among our workforce and eliminating unlawful discrimination. We strive to provide equality, fairness, and respect for all in our employment, whether temporary, part-time, or full-time.”

Nicox Ophthlamics, Inc.

4819 Emperor Blvd.

Durham, NC 27703