In-House CRA II for Oncology Trials

Worldwide; North Carolina, United States, Northern America, Americas; Hybrid; USD 50.000 - 99.000; Vollzeit

Zusammenfassung

Worldwide Clinical Trials is seeking an In-House Clinical Research Associate II to manage site activities for oncology studies in accordance with GCPs and SOPs, and to support CTMs and field CRAs. Experience in oncology is required, with a four-year degree in a related science and at least two years in clinical research.

You will mentor in-house team members, coordinate feasibility and TMF/ISF tasks, perform remote monitoring, review EDC data for quality, and generate site reports to keep trials

Qualifikationen

• Oncology experience required (clinical research setting).
• Four-year college curriculum in related science.
• Two years of clinical research experience in a related role.

Aufgaben

• Assist with feasibility questionnaires and CDA collection from potential sites.
• Coordinate shipment and receipt of study materials by sites.
• Maintain TMF documentation updates and review for quality.
• Support ISF maintenance and TMF reconciliation.
• Conduct pre-study, initiation, interim, and close-out visits under guidance.
• Assist with IP inventory discussions when applicable.
• Maintain regular communication with sites per monitoring plans.
• Perform remote review of EDC CRFs for completion and data quality.
• Pull reports and maintain study trackers for CTM distribution.
• Provide visit preparation support for field CRAs.
• Assist with site staff changes and regulatory document collection.
• Support vendor access management for site staff.
• Assist with prescreening, screening, and recruitment.
• Help with Subject Eligibility Review tracking and medical monitor support.

Kenntnisse

Communication

Planning

Organizational skills

Interpersonal skills

Clinical research knowledge

FDA/EU guidelines knowledge

SOPs knowledge

Microsoft Office

IVRS

eCRF systems

Ausbildung

Four-year college degree in medical/biological/physical/health science

Tools

Microsoft Office

Jobbeschreibung

Worldwide Clinical Trials is seeking an In-House Clinical Research Associate II to manage site activities for oncology studies in accordance with GCPs and SOPs, and to support CTMs and field CRAs. Experience in oncology is required, with a four-year degree in a related science and at least two years in clinical research.

You will mentor in-house team members, coordinate feasibility and TMF/ISF tasks, perform remote monitoring, review EDC data for quality, and generate site reports to keep trials