In-House Clinical Research Associate: End-to-End Study Support

Initial Therapeutics, Inc.; Malvern (Chester County); On-site; USD 85,000 - 110,000; Full time

Job summary

Ocugen is seeking an In-House Clinical Research Associate to support the planning, execution, and close-out of ophthalmology clinical studies, ensuring study quality, timelines, and regulatory compliance per ICH/GCP and SOPs. The role involves TMF/eTMF maintenance, CTMS usage, and collaboration with cross-functional teams.

The position is based in Malvern, PA, requiring in-person work five days a week with occasional travel.

Qualifications

• Excellent communication and collaboration with cross-functional teams.
• Experience with eTMF, CTMS and EDC systems.
• Knowledge of ICH-GCP guidelines and regulatory requirements.

Responsibilities

• Support study start-up, execution, maintenance, and close-out activities.
• Assist with investigator/site identification, feasibility, and recruitment processes.
• Maintain study document version tracker and document control.
• Upload study documents in CTMS and TMF/eTMF.
• Track Investigational Product shipments and ensure proper documentation in TMF.
• Coordinate with CRAs and CTMs for study management, meetings, and minutes.
• Ensure inspection readiness and compliance with SOPs and regulations.

Skills

Excellent communication

Team collaboration

Regulatory knowledge

Study start-up

Documentation

Tools

eTMF

CTMS

EDC

Job description

Ocugen is seeking an In-House Clinical Research Associate to support the planning, execution, and close-out of ophthalmology clinical studies, ensuring study quality, timelines, and regulatory compliance per ICH/GCP and SOPs. The role involves TMF/eTMF maintenance, CTMS usage, and collaboration with cross-functional teams.

The position is based in Malvern, PA, requiring in-person work five days a week with occasional travel.