CRA I/II - SR CRA I

Thermo Fisher Scientific; United States; Remote; USD 60,000 - 90,000; Full time

Job summary

Une entreprise de premier plan dans le secteur des sciences de la vie recherche un professionnel pour surveiller les sites des études cliniques. Dans ce rôle, vous serez responsable de garantir la conformité des protocoles, d’assurer l'exactitude des données et de gérer des processus d'amélioration continue. Un bon sens de l'analyse et des compétences en communication sont essentiels pour réussir. Vous collaborerez avec des équipes internes et des sites d'investigation pour garantir des résultats optimaux.

Qualifications

• Expérience avec la gestion et la surveillance des essais cliniques.
• Compétences en communication écrite et orale.
• Connaissance des réglementations ICH-GCP.

Responsibilities

• Surveille les sites d'investigation et assure la conformité des protocoles.
• Documente les observations et résout les problèmes en collaboration avec les équipes.
• Participe aux processus de paiement et aux réunions des investigateurs.

Skills

Critical thinking

Problem-solving

Root cause analysis

Education

Bachelor's degree in Life Sciences or related field

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

* Monitors investigator sites using a risk-based monitoring approach, applying root cause analysis (RCA), critical thinking, and problem-solving skills to identify site process failures and implement corrective/preventive actions to ensure compliance and reduce risks. Ensures data accuracy through SDR, SDV, and CRF review during on-site and remote monitoring activities.

* Assesses investigational products through physical inventory and records review.

* Documents observations in reports and letters promptly, following approved business writing standards. Escalates deficiencies and issues to clinical management and follows through to resolution. Maintains regular contact with investigative sites between visits to confirm protocol adherence, resolution of issues, and timely data recording. Conducts monitoring tasks as per the approved monitoring plan.

* Participates in the investigator payment process. Collaborates with the project team to resolve issues/findings. Investigates and follows up on findings as needed. Attends investigator meetings when required. Assists in identifying potential investigators with the client to ensure site suitability. Initiates clinical trial sites following relevant procedures to ensure protocol and regulatory compliance, including ICH GCP obligations. Manages trial close-out and retrieval of trial materials.

* Ensures completeness and accuracy of essential documents in accordance with ICH-GCP and regulations. Conducts on-site file reviews as specified by the project.

* Provides trial status updates and progress reports. Ensures study systems are complete, accurate, and updated according to study conventions (e.g., Clinical Trial Management System).

* Facilitates effective communication between investigative sites, the client, and internal teams via written, oral, and electronic means. Responds to company, client, and regulatory requirements, audits, and inspections.

* Contributes to project team efforts by assisting in preparing publications/tools and sharing ideas for process improvement.

* Completes administrative tasks such as expense reports and timesheets promptly.

* Supports other project activities and initiatives aimed at process improvement.