Ocugen Opco

Purpose

The In-House Clinical Research Associate supports the planning, execution, and closeout of Ocugen clinical studies to ensure study quality, timelines, and regulatory compliance. These activities are performed in accordance with the study protocol, Ocugen standard operating procedures (SOPs), ICH/GCP guidelines, and applicable regulatory requirements.

Responsibilities

• Support study start-up, execution, maintenance, and close-out activities for assigned clinical trials.
• Assist with investigator/site identification, feasibility, and recruitment activities.
• Develop and maintain the study document version tracker to ensure document control and version accuracy.
• Upload study documents in the Clinical Trial Management System (CTMS) and Trial Master File (TMF).
• Tracks Investigational Product shipments, returns, destruction and ensures appropriate documentation is filed in the TMF.
• Track and maintain: Subject enrollment, Bioanalytic sample inventory, shipments, and receipt, database queries and resolution.
• Support CRAs and CTMs with study management activities, including vendor oversight, Investigator meeting planning, scheduling study team meetings to include agenda and meeting minutes.
• Coordinate with CRAs to review, maintain, and reconcile essential regulatory and study documents to ensure inspection readiness and compliance with ICH-GCP, SOPs, and applicable regulations.
• Perform routine TMF quality control reviews and coordinate reconciliation activities with field CRAs to ensure inspection readiness and document completeness.
• Supports field CRA(s) and investigational sites with regulatory submissions, IRB/IEC communications, and study-related documentation requirements.
• Serve as a point of contact for investigational sites regarding study questions, documentation, timelines, and operational support as needed.
• Manage and track subject travel reimbursement.
• Coordinate documents for site activation, prepare Investigational Site Green Light form for CTM sign off.
• Assist in the preparation and maintenance of study operational documents, including study plans, monitoring guidelines, site manuals, templates, and training materials.
• Review informed consent forms and essential documents for completeness, quality, and compliance.
• Collaborate with cross-functional teams and vendors to support study deliverables and project goals.
• Identify and escalate study risks, issues, and out-of-scope activities to study manager as appropriate.
• Ensure study activities are conducted in compliance with study protocols, Clinical Management Plans, SOPs, and applicable regulatory requirements.
• Support inspection and audit readiness activities as needed.
• Supports study budget tracking and invoice reconciliation activities as requested
• Perform ongoing eTMF maintenance activities including document filing, QC review, reconciliation, tracking of missing documents, and follow-up with study teams and investigational sites to ensure TMF completeness and inspection readiness.
• Supports preparation and collection of study documentation and data required for safety reviews as applicable
• Proactively identifies risks, developing and implementing mitigation plans as applicable.
• May assist in developing policies and procedures (SOPs).
• Perform additional responsibilities as assigned.

• Excellent communication and collaboration skills with a team-oriented approach.
• Experience with eTMF, CTMS and EDC, (MS Project or Smart sheets timelines desired).
• CRO/vendor management experience is preferred
• Experience in Ophthalmology and/or advanced therapy studies in Phases 1-3 desired.

Working Conditions

• This position operates in an office setting, 5 days per week in-person with occasional travel (up to 20%)
• Job may additionally require incumbent to be available outside of these hours to handle priority business needs.

Ocugen is an equal opportunity employer. In order to provide equal employment and advancement opportunities to all individuals, we make all of our employment decisions based upon merit, qualifications, abilities, and an individual's conduct and performance. We will not make any of our decisions, and will not discriminate against any employee or applicant, on the basis of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including sexual orientation, gender identity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, or any other characteristic protected from discrimination under the law. Ocugen complies with applicable federal, state and local laws governing nondiscrimination in employment.