Sr. Clinical Research Associate (US) (Fully Remote)

Alimentiv; Deutschland; Remote; EUR 55.000 - 85.000; Vollzeit

Zusammenfassung

Alimentiv, a clinical research organization, seeks a Clinical Research Associate to conduct onsite and remote monitoring visits, ensuring ICH/GCP compliance and driving site initiation and close-out activities. You will review source documents, coordinate shipments of clinical supplies, and maintain ISF/TMF files while supporting site activation and patient recruitment to meet project milestones.

Mentorship and audits are also part of this role.

Qualifikationen

• Experience conducting ICH/GCP compliant monitoring visits.
• Ability to review source documents and resolve data queries.
• Familiarity with TMF/ISF documentation and regulatory requirements.
• Experience mentoring junior CRAs and participating in audits.

Aufgaben

• Conduct onsite and remote monitoring visits, including site qualification, initiation, and close-out.
• Review source documents, resolve data queries, and ensure compliance with ICH/GCP and regulations.
• Coordinate shipment of clinical supplies and maintain study files (ISF, TMF).
• Identify and advise on site investigators; perform site selection and initiation visits.
• Support site activation and patient recruitment to meet milestones.
• Mentor CRA I/II and participate in candidate interviews and process improvements.
• Represent the team in audits, inspections, and study progress meetings.

Kenntnisse

Onsite monitoring

Remote monitoring

ICH/GCP compliance

Study monitoring

Site activation

Data review

Regulatory collaboration

Audits & inspections

TMF/ISF management

Jobbeschreibung

• Conduct onsite and remote monitoring visits, including site qualification, initiation, and close-out.
• Review source documents, resolve data queries, and ensure compliance with ICH/GCP and regulations.
• Coordinate shipment of clinical supplies and maintain study files (ISF, TMF).

Site Recruitment and Setup:

• Identify and advise on site investigators; perform site selection and initiation visits.
• Support site activation, patient recruitment, and ensure project milestones are met.
• Collaborate with start-up and regulatory teams to finalize documents and translations.

Mentoring and Internal Initiatives:

• Mentor and assess CRA I and II through co-monitoring visits and feedback.
• Participate in candidate interviews and contribute to best practices and process improvements.
• Represent the team in audits, inspections, and study progress meetings.

Alimentiv

Alimentiv is a clinical research organization that provides clinical trial monitoring and site management services. The company fosters a dynamic, results-driven, and high-accountability environment with a focus on quality and compliance.