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Clinical Research Associate

2 months ago

Malvern, Pennsylvania, United States Ocugen, Inc. Full time
Job Summary

Ocugen, Inc. is seeking a highly skilled Clinical Trial Associate to support the operational execution of clinical studies. This individual will be responsible for delivering clinical studies according to agreed cost and timelines while ensuring patient safety and data integrity and quality.

Key Responsibilities
  • Study Execution: Develops and directs clinical study and operational activities, managing their execution to ensure completion according to project timelines and budget.
  • Team Leadership: Leads the study execution team, ensuring that studies are conducted in adherence to study protocols, applicable SOPs, ICH/GCP guidelines, and government regulations.
  • Protocol Development: Reviews and contributes to the development of protocols, amendments, case report forms, and clinical study reports. Develops informed consents and contributes to the development of annual reports and investigational brochures.
  • Site Identification and Qualification: Drives the identification, assessment, and qualification of clinical research sites. Ensures training of all investigational sites, including planning of Investigator Meetings and development of site training materials.
  • Study Planning and Tracking: Develops study operational documents, including timelines, enrollment projections, and study plans. Tracks performance relative to timelines and projections, ensuring compliance with study plans.
  • Collaboration and Oversight: 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.
  • CRO and Vendor Management: Assists in the identification and selection of CROs and clinical vendors. May manage the RFI and RFP process.
  • Vendor Management: Manages clinical vendors, including CROs, tracking of deliverables to ensure they are within timeline and budget.
  • Study Status Updates: Provides study status updates to senior management and escalates study risks, as applicable.
  • Audit and Budget Planning: 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.
  • Data Delivery: Ensures timely delivery of data for external safety board reviews, as applicable.
  • Risk Management: Proactively identifies risks, developing and implementing mitigation plans, as applicable.
  • Policies and Procedures: May assist in developing policies and procedures (SOPs).
Requirements
  • Education: BA/BS degree in life sciences.
  • Experience: 3+ years of progressive clinical research experience in the biotechnology/pharmaceutical industry.
  • CRO/Vendor Management: Must have CRO/vendor management experience.
  • Specialized Knowledge: Strong knowledge of GCPs, ICH, and FDA regulatory requirements governing human clinical studies.
  • Skills: 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.
  • Technical Skills: Experience with eTMF, CTMS, and EDC.
Working Conditions
  • This position operates in an office setting and may include 20% of travel to visit sites. This job may require the incumbent to be available outside of regular hours to handle priority business needs.
Physical Requirements
  • This is a largely sedentary role but may in addition require standing, bending, kneeling, and lifting weights up to about 10lbs.