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The Senior 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.

• Assist the clinical team in preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures
• Assist with accurately updating and maintaining clinical systems that track compliance and performance within project timelines according to ICH-GCP and local regulations
• Assist the CMC and unmasked clinical team with site follow-up, preparation, handling, distribution, filing, and archiving of unmasked clinical/CMC documentation and reports according to the scope of work and standard operating procedures
• Support investigational product (IP) return from study sites, provide shipping labels and review IP return paperwork
• Provide clinical study start-up expertise and support, including, but not limited to, essential document collection and IRB submissions
• Collaborate with external vendors and partners
• Organize in-house portions of clinical studies
• Assist with CRO clinical team and unmasked field CRAs with project-related activities
• Assist with the preparation, review, and distribution of study correspondence
• Act as a point of contact for clinical site questions and support requests, and escalate as appropriate

• B.S. or B.A. degree in scientific discipline.
• 5 years of work experience for a pharmaceutical company in Clinical Research preferably in Ophthalmology in the areas of glaucoma, blepharitis and/or dry eye.
• Certified training in GCP.
• Proficient with Microsoft Office Word, Excel, and PowerPoint.
• Experience with various study systems (EDC, IRT, IRB portals, eTMF, CTMS, etc.) used in clinical trials
• Excellent organization skills and ability to multi-task.
• Outstanding communication skills, both verbal and written in English. Spanish is a plus.
• Ability to work independently and prioritize duties.
• Available to travel.
• Valid driver’s license.

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

The Director of Clinical Development is accountable for the operational strategic planning, oversight and delivery of assigned clinical programs in accordance with ICH, US regulations and Nicox Quality Management System. 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. He/She implements and oversees clinical project(s) from initiation to clinical report writing. Programs may involve partial or full services provided by a qualified CRO. He/She interacts and assists clinicians, clinical research coordinators and all other site clinical research personnel to ensure operational excellence and compliance with established regulations.

• Manage clinical studies, according to ICH-GCP and local regulations, maintain projects within pre-defined timelines and budget and evaluate and/or propose study resource allocations within Nicox

• Manage study specific trainings within Nicox

• Ensure the quality of study data

• Manage CRO(s) including:

  • Active participation in CRO selection

  • Primary point of contact with study CRO and overall supervision of CRO activities of assigned projects

  • Set up and initiation of clinical studies from Phase 1 to 3

  • Attending and participating in Investigator’s Meetings as trainer of selected topics

  • Review, finalization and authorization (if appropriate) of CRO project-related documents

  • Performing site visits (co-monitoring or alone)

  • Participation in ongoing review of study data with focus on protocol deviations

  • Participation in Nicox-CRO(s) teleconferences/meetings

  • Liaising with vendors participating in the programs

  • Tracking of study progress, invoices, and other project management tasks

  • Escalation of issues to the VP and Head of Clinical Development and/or Chief Scientific Officer, as appropriate

  • Review of Statistical Analysis Plan, draft and final Tables, Figures and Listings

  • Participation in and organization and review of the Clinical Study Report

  • Review audit reports and respond or take necessary actions to resolve any issues raised

• Organize in-house portions of clinical studies including:

  • Planning the clinical study supplies necessary for project implementation, in co- operation with Pharmaceutical Development

  • Tracking/management of study progress, payments, and other project tasks.

  • Managing information flow/communication with all relevant groups to ensure smooth running of the projects

• Manage in-house CRA’s and CTA’s project related activities (if applicable)

• Participate in the recruitment, selection and training of in-house clinical staff

• Participate in study design and writing of protocols

• Participate in development of clinical procedures and propose necessary procedures writing of the SOPs, as appropriate

• Actively participate on the Project teams

• To back up other Team members in case of absence, travel, etc., if and when applicable.

• M.S. preferred

• Five (5) plus years of experience on Clinical Research in Ophthalmology preferably in the areas of glaucoma, and dry eye

• Certified training in GCP

• Advanced proficiency in Microsoft Office Programs (Outlook, Excel, Word, Access, Project, PowerPoint) and able to function remotely from local network.

• Exceptional interpersonal, organizational, time management, and communication (verbal and written)

• Outstanding communication skills, both verbal and written in English. Spanish is a plus.

• Detailed understanding and familiarity with ophthalmic diagnostic tests and equipment used at clinical sites.

• Experience with various study systems (InForm, MediData, Perceptive, Trident, reading center portals, etc.) used in clinical trials

• Excellent organization skills and ability to multi-task.

• Travel to CRO(s) and clinical sites as necessary is required in the US and infrequent travel (once or twice a year) outside US as needed.

• Valid driver’s license.

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.