Wound Care Clinical Research Associate - Remote

Jobgether SRL; United States; À distance; USD 90 000 - 130 000; Plein temps

Résumé du poste

Jobgether SRL seeks a Clinical Research Associate with wound care trial experience to monitor sites, ensure data integrity, and uphold GCP standards. The role involves remote and onsite visits, collaboration with sponsors and cross-functional teams, and contributing to study planning and audits.

You will mentor peers, support patient recruitment oversight, and participate in CTMS and TMF management while maintaining regulatory readiness in a global, remote-friendly environment.

Qualifications

• Bachelor's degree in Biology, Life Sciences, or related field.
• Minimum 2 years of wound care trial monitoring experience.
• Strong knowledge of ICH GCP and regulatory requirements.
• Ability to autonomously manage monitoring activities and ensure compliance.
• Experience with CTMS, EDC, and TMF/document management.

Responsabilités

• Conduct site qualification, initiation, interim, and close-out visits (remote and onsite).
• Prepare monitoring visit reports detailing site issues and actions.
• Review CRFs and source data for accuracy and completeness.
• Ensure regulatory and protocol compliance across studies.
• Maintain site relationships and coordinate with investigators and staff.
• Facilitate SAE reporting and investigational product oversight.
• Prepare regulatory binders and assist audits when required.
• Contribute to study planning and training materials.
• Provide guidance and onboarding for new CRAs; support team collaboration.
• Manage budgets for monitoring projects and provide monthly billing info.
• Contribute to CTMS development and cross-functional coordination.

Connaissances

Wound care trials

Independent monitoring

Regulatory compliance

Data integrity

Site management

Communication

Travel readiness

Mentoring

Formation

Bachelor's degree in Biology/Life Sciences

Outils

CTMS

EDC platforms

eTMF/TMF

Description du poste

Jobgether SRL seeks a Clinical Research Associate with wound care trial experience to monitor sites, ensure data integrity, and uphold GCP standards. The role involves remote and onsite visits, collaboration with sponsors and cross-functional teams, and contributing to study planning and audits.

You will mentor peers, support patient recruitment oversight, and participate in CTMS and TMF management while maintaining regulatory readiness in a global, remote-friendly environment.