Overview
Desplácese hacia abajo para ver todos los requisitos del puesto y las responsabilidades que pueden esperar los candidatos seleccionados.
In this CRA II role, you will oversee clinical trial activities to ensure protocol and regulatory compliance across sites. You will work closely with site teams and cross-functional partners to monitor data integrity, patient safety, and trial progress. You’ll apply risk-based monitoring techniques and drive site performance improvements to support study success.
The position offers exposure to real-world late-phase studies and a collaborative, outcomes-focused culture. This is a mission-driven opportunity to help accelerate healthcare progress through rigorous trial oversight.
Compensaciones / Beneficios
- career development
- inclusive culture
- total rewards program
- peer recognition
- technical and therapeutic area training
- supportive line management
Responsabilidades
- Conduct site qualification, initiation, monitoring, and close-out visits (on-site or remote) ensuring ICH-GCP/GPP compliance
- Assess site performance and provide actionable recommendations; escalate serious issues promptly
- Maintain knowledge of ICH/GCP, regulations, and SOPs; ensure informed consent is properly obtained
- Verify data quality and source document integrity; perform IP inventory and handling per protocol
- Ensure accurate IP dispensing, labeling, and release; manage IP labeling/return as needed
- Review ISF and TMF reconciliation; ensure archiving of essential documents
- Support patient recruitment and retention strategies; track observations and action items
- Coordinate training and communication with site staff; prepare for meetings and audits
- Assist with audit readiness and post-audit follow-up actions; adapt to project scope, budgets, and timelines
- Provide Real World Late Phase site support, including chart abstraction and collaboration with sponsor affiliates
- May train junior staff and identify out-of-scope activities for escalation
xugodme
Requisitos principales
- Bachelor in related field
- Experience in oncology, hematology, and gynecologic oncology clinical trials
- Knowledge of GCP/ICH guidelines and regulatory requirements
- Good computer skills and ability to adapt to new technologies
- Excellent communication, presentation and interpersonal skills
- Ability to travel up to 75%
- strong communication and interpersonal skills
- adaptability to changing priorities
- problem-solving and proactive mindset
- ICH/GCP guidelines
- GCP/ICH regulatory requirements
- electronic data capture (EDC) systems usage
Jobrapido
