In-House Clinical Research Associate — Trials & Compliance

Ocugen; Malvern (Chester County); On-site; USD 85,000 - 125,000; Full time

Job summary

Ocugen is seeking an In-House Clinical Research Associate to support planning, execution, and close-out of clinical studies in compliance with ICH/GCP and SOPs. The role requires collaboration with cross-functional teams, site identification, and TMF upkeep.

The successful candidate will manage study documents, vendor oversight, site communications, and regulatory submissions, with occasional travel as needed. Office-based with travel up to 20% preferred.

Qualifications

• 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.

Responsibilities

• Support study start-up, execution, maintenance, and close-out activities.
• Assist with investigator/site identification, feasibility, and recruitment activities.
• Develop and maintain the study document version tracker to ensure document control.
• Upload study documents in CTMS and TMF and track shipments.
• Monitor subject enrollment, sample inventory, and data queries; support meetings and vendor oversight.

Skills

Excellent communication

Collaboration

Teamwork

Vendor management

Tools

eTMF

CTMS

EDC

MS Project

Smartsheet

Job description

Ocugen is seeking an In-House Clinical Research Associate to support planning, execution, and close-out of clinical studies in compliance with ICH/GCP and SOPs. The role requires collaboration with cross-functional teams, site identification, and TMF upkeep.

The successful candidate will manage study documents, vendor oversight, site communications, and regulatory submissions, with occasional travel as needed. Office-based with travel up to 20% preferred.