In-House Clinical Trials Operations Associate

BioSpace; Malvern (Chester County); On-site; USD 90,000 - 120,000; Full time

Job summary

Ocugen in Malvern, PA, is seeking an In-House Clinical Research Associate to support the planning, execution, and closeout of clinical studies, ensuring study quality, timelines, and regulatory compliance in line with ICH/GCP and SOPs.

The role includes site activation and identification, CTMS/TMF uploads, subject enrollment tracking, vendor oversight, regulatory submissions, and collaboration with cross-functional teams to meet study deliverables and inspection readiness.

Qualifications

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

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 CTMS and TMF; track subject enrollment and shipments.
• Coordinate with CRAs for study management, vendor oversight, and study team meetings.
• Maintain regulatory documents to ensure inspection readiness and compliance with ICH-GCP and SOPs.
• Perform TMF quality control reviews and reconciliation with field CRAs.
• Support regulatory submissions, IRB/IEC communications, and documentation requirements.
• Serve as a point of contact for investigational sites regarding study questions and timelines.
• Assist in study budget tracking, invoice reconciliation, and TMF completeness.

Skills

Communication

Collaboration

Teamwork

Tools

eTMF

CTMS

EDC

MS Project

Job description

Ocugen in Malvern, PA, is seeking an In-House Clinical Research Associate to support the planning, execution, and closeout of clinical studies, ensuring study quality, timelines, and regulatory compliance in line with ICH/GCP and SOPs.

The role includes site activation and identification, CTMS/TMF uploads, subject enrollment tracking, vendor oversight, regulatory submissions, and collaboration with cross-functional teams to meet study deliverables and inspection readiness.