(Senior) Clinical Research Associate

General Position Summary:

The Clinical Research Associate is responsible for leading specific study workstreams and providing high-level oversight of clinical trial execution. Working closely with the Clinical Project Manager, this role ensures that all trial activities comply with the protocol, ICH-GCP guidelines, and Cellphire’s clinical objectives. The CRA contributes to vendor management, ensures data integrity, and maintains an elevated level of professionalism with both internal cross-functional teams and external trial sites. 

PRIMARY RESPONSIBILITES:

Study Startup & Site Management 

Cross-Functional Collaboration: Partner with R&D, QA, Finance, and Logistics to compile startup documentation and track relevant milestones.  Coordinates and reviews regulatory documents from study sites.  

Site Management: Serve as the primary sponsor owner for CRO‑managed investigational sites, ensuring effective site management, compliance, and performance.  Provide day-to-day oversight of CRO CRAs responsible for site selection, activation, monitoring, and close‑out activities. Oversee CRO management of site communications, ensuring clarity, consistency, and appropriate sponsor involvement when required.  Ensure CRO appropriately manages protocol deviations, informed consent issues, and GCP compliance concerns at the site level.

Clinical Monitoring & CRO Oversight

Oversight Monitoring (ICH E6 5.18): Conduct oversight visits to verify the adequacy of CRO monitoring and ensure that Principal Investigator (PI) oversight is documented and maintained.  Maintain concise, fit‑for‑purpose oversight documentation demonstrating sponsor control of outsourced activities including review and approval of CRO site management deliverables. Monitor CRO adherence to the Monitoring Plan, RBQM strategy, SOPs, ICH-GCP and contractual deliverables, raising concerns early. Ensure the CRO is identifying, escalating, and addressing risks related to data, safety, protocol compliance, and site performance.

TMF Governance: Conduct quality oversight of the eTMF, review management metrics and document quality to ensure audit readiness.

Data Review and Integrity (ALCOA ): Act as the day‑to‑day sponsor owner for CRO‑led centralized data review and RBM activities. Routinely review CRO data review outputs (dashboards, listings, KRIs, QTLs, trend analyses) to independently assess data quality and emerging risks.  Perform spot checks and targeted reviews of monitoring documentation to ensure accuracy, completeness, and inspection readiness. 

Trial Management & Leadership

Study Tools: Support the design of Case Report Forms (CRFs) and develop guidelines and study tools for site use.  Responsible for tracking clinical documents as applicable Apply clinical and protocol knowledge to challenge, validate, and contextualize CRO findings, rather than relying solely on reported metrics.

Clinical Supply: Coordinate with Logistics and the CRO to manage Investigational Product (IP) shipments and accountability records. 

Financial Support: Assist leadership with investigator budgets and payment tracking, including the review of legal language in site contracts.

Representation: Represent Cellphire at Investigator Meetings and provide formal presentations to study coordinators.  Serve as a key contributor during audits and regulatory inspections, clearly articulating how the sponsor maintains oversight of CRO activities.  Collaborate directly with internal Clinical Operations, Data Management, Safety, and Biostatistics to translate CRO findings into sponsor decisions.

Corrective Actions: Lead the identification of systemic site issues and develop Corrective and Preventive Action (CAPA) plans to resolve GCP non-compliance.

Process Improvement: Identify gaps in current clinical workstreams and support the development of departmental SOPs and study-specific tools and training to increase efficiency.