Clinical Trial Associate

at  Ocugen Opco Inc

PHYSICAL REQUIREMENTS

This is a largely sedentary role

The Clinical Trial Associate supports the operational execution of clinical studies. This individual is responsible for the delivery of clinical studies according to agreed cost and timelines while ensuring patient safety, data integrity and quality.

Dutiesand Responsibilities

• Assists with the development of clinical study and operational activities with Clinical Research Associates and Clinical Trial Managers to ensure completion according to project timelines and budget.
• Assists the study execution team ensuring that studies are conducted in adherence to study protocols, applicable SOPs, ICH/GCP guidelines and government regulations.
• Reviews and contributes to development of protocols, amendments, case report forms and clinical study reports.
• Assists with administrative activities for the identification, assessment, and qualification of clinical research sites. Ensures tracking of training and regulatory material collection and filing of all investigational sites including planning of Investigator Meetings and development of site training materials.
• Assists in the tracking and development of study operational documents which may include timelines, enrollment projections and study plans. Assist with tracking performance relative to timelines and projections and ensures compliance with study plans.
• Works collaboratively with internal CRAs to ensure oversight of site initiation, interim monitoring, and site closure activities. Ensures the TMF is developed, maintained, reconciled, and archived.
• Assists in the identification and selection of CROs and clinical vendors. May manage the documentation of RFI and RFP process.
• Manages clinical vendors including CROs including tracking of deliverables to ensure they are within timeline and budget.
• Provides study status updates to senior management and escalates study risks, as applicable.
• Works collaboratively with colleagues in Quality Assurance to develop and administer a study audit plan.
• Works collaboratively with colleagues in Finance to forecast, phase and manage study budgets.
• Proactively identifies risks, developing and implementing mitigation plans as applicable.
• May assist in developing policies and procedures (SOPs).
• Additional tasks and projects as requested.
• BA/BS degree, in life sciences.
• 1+ years of progressive clinical research experience in the biotechnology/pharmaceutical industry
• Must have CRO/vendor management experience.
• Experience in Ophthalmology and/or advanced therapy studies in Phases 1-3 highly desired.
• Strong knowledge of GCPs, ICH, and FDA regulatory requirements governing human clinical studies.
• Demonstrated attention to detail and outstanding organization skills.
• Self-motivated with a commitment to high quality, on-time deliverables.
• Excellent communication and collaboration skills with a team-oriented approach.
• Experience with eTMF, CTMS and EDC.
• Demonstrated ability to identify and resolve issues and effectively manage timelines.

WorkingConditions
This position operates in an office setting and may include 20% of travel to visit sites, vendors or CROs. Job may require incumbent to be available outside of these hours to handle priority business needs.