In-House Clinical Research Associate
Ocugen
August 25, 2026
On-site
Malvern, PA
Clinical Research and Development
Responsibilities:
- Support study start-up, execution, maintenance, and close-out for assigned clinical trials.
- Assist with investigator/site identification, feasibility, and recruitment.
- Develop and maintain study document version tracker; ensure document control and accuracy.
- Upload study documents in CTMS and Trial Master File (TMF).
- Track investigational product shipments, returns, and destruction; ensure TMF documentation.
- Track and maintain subject enrollment; bioanalytic sample inventory, shipments, receipt; database queries and resolution.
- Support CRAs/CTMs with study management (vendor oversight, investigator meeting planning, scheduling study team meetings with agenda and minutes).
- Coordinate with CRAs to review, maintain, and reconcile essential regulatory/study documents for inspection readiness and ICH-GCP/SOP compliance.
- Perform routine TMF quality control reviews and coordinate reconciliation with field CRAs.
- Support investigational sites with regulatory submissions, IRB/IEC communications, and study documentation.
- Act as a point of contact for site questions, timelines, and operational support.
- Manage subject travel reimbursement; coordinate site activation (prepare Investigational Site Green Light for CTM sign-off).
- Prepare/maintain operational documents (study plans, monitoring guidelines, site manuals, templates, training materials).
- Review informed consent forms and essential documents for completeness, quality, and compliance.
- Collaborate cross-functionally with teams/vendors to support deliverables.
- Identify/escalate study risks/issues and out-of-scope activities to study manager; ensure compliance with protocols/Clinical Management Plans/SOPs/regulations.
- Support inspection/audit readiness; assist with budget tracking and invoice reconciliation.
- Conduct ongoing eTMF maintenance (filing, QC, reconciliation, missing-document follow-up).
- Support safety review documentation/data collection; develop/implement risk mitigation; may assist with SOP policy/procedure development.
Qualifications:
- Excellent communication and collaboration skills; team-oriented approach.
- Experience with eTMF, CTMS, and EDC (MS Project or Smart sheets timelines desired).
- CRO/vendor management experience preferred.
- Experience in Ophthalmology and/or advanced therapy studies in Phases 1–3 desired.
- Support study start-up, execution, maintenance, and close-out for assigned clinical trials.
- Assist with investigator/site identification, feasibility, and recruitment.
- Develop and maintain study document version tracker; ensure document control and accuracy.
- Upload study documents in CTMS and Trial Master File (TMF).
- Track investigational product shipments, returns, and destruction; ensure TMF documentation.
- Track and maintain subject enrollment; bioanalytic sample inventory, shipments, receipt; database queries and resolution.
- Support CRAs/CTMs with study management (vendor oversight, investigator meeting planning, scheduling study team meetings with agenda and minutes).
- Coordinate with CRAs to review, maintain, and reconcile essential regulatory/study documents for inspection readiness and ICH-GCP/SOP compliance.
- Perform routine TMF quality control reviews and coordinate reconciliation with field CRAs.
- Support investigational sites with regulatory submissions, IRB/IEC communications, and study documentation.
- Act as a point of contact for site questions, timelines, and operational support.
- Manage subject travel reimbursement; coordinate site activation (prepare Investigational Site Green Light for CTM sign-off).
- Prepare/maintain operational documents (study plans, monitoring guidelines, site manuals, templates, training materials).
- Review informed consent forms and essential documents for completeness, quality, and compliance.
- Collaborate cross-functionally with teams/vendors to support deliverables.
- Identify/escalate study risks/issues and out-of-scope activities to study manager; ensure compliance with protocols/Clinical Management Plans/SOPs/regulations.
- Support inspection/audit readiness; assist with budget tracking and invoice reconciliation.
- Conduct ongoing eTMF maintenance (filing, QC, reconciliation, missing-document follow-up).
- Support safety review documentation/data collection; develop/implement risk mitigation; may assist with SOP policy/procedure development.
Qualifications:
- Excellent communication and collaboration skills; team-oriented approach.
- Experience with eTMF, CTMS, and EDC (MS Project or Smart sheets timelines desired).
- CRO/vendor management experience preferred.
- Experience in Ophthalmology and/or advanced therapy studies in Phases 1–3 desired.