Impactful In-House Clinical Research Associate

Ocugen Opco Inc

Malvern (AR)

On-site

USD 70,000 - 110,000

Full time

14 days+

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Job summary

Ocugen seeks an In-House Clinical Research Associate to support planning, execution, and closeout of clinical studies, ensuring quality and regulatory compliance. You will work with cross-functional teams, assist with site identification, feasibility, recruitment, and maintain CTMS/TMF documentation, while ensuring inspection readiness and adherence to ICH-GCP.

The role involves 5 days in-office with up to 20% travel, and requires collaboration with CRAs and vendors to meet study deliverables

Qualifications

Bachelor’s degree in life sciences required.
Experience with eTMF, CTMS and EDC.
Knowledge of ICH-GCP guidelines and regulatory requirements.
Strong communication and collaboration skills.

Responsibilities

Support study start-up, execution, maintenance, and close-out activities.
Assist with investigator/site identification, feasibility, and recruitment activities.
Upload study documents in the CTMS and TMF.
Track and maintain essential regulatory documents to ensure inspection readiness.
Coordinate with CRAs and CTMs for study management activities and meetings.
Review informed consent forms and essential documents for completeness and compliance.
Support study budget tracking and invoice reconciliation.