In-House Clinical Research Associate (IHCRA) – Oncology Studies

Coalition of Cancer Cooperative Groups; Philadelphia (Philadelphia County); Híbrido; USD 72.000 - 110.000; Jornada completa

Descripción de la vacante

Coalition of Cancer Cooperative Groups is seeking an experienced In-House Clinical Research Associate (IHCRA) to coordinate and oversee oncology clinical trials in a hybrid work setting. You will work with the Senior Director, Clinical Trial Managers, Project Managers, and other CRAs to ensure adherence to GCP, SOPs, and FDA regulations.

Advanced opportunities may be available for candidates with prior site monitoring experience and the ability to review and evaluate monitoring trip reports.

Formación

• Minimum of three (3) years of oncology clinical research experience.
• Experience as a CRA/monitor/auditor or similar role in oncology.
• Strong organizational, communication and documentation skills.

Responsabilidades

• Collaborate with investigators, site personnel, IRB staff and sponsor/funder representatives to support study management.
• Conduct pre-study activities, remote SIVs, site closeout visits and other monitoring activities.
• Assist with site identification and feasibility activities and provide recommendations to project leadership.
• Prepare site regulatory packet templates and coordinate regulatory documentation review.
• Generate and review database reports to identify missing or incomplete EDC data and follow up with monitors.
• Maintain site tracking reports, site contact logs, and study documentation reports.

Conocimientos

Organizational skills

Communication skills

Documentation skills

Collaborative work

Educación

Bachelor's degree

Descripción del empleo

We are seeking an experienced In-House Clinical Research Associate (IHCRA) to support the coordination and oversight of oncology clinical trials. This is a hybrid opportunity for an experienced clinical research professional looking to apply their oncology research knowledge in a collaborative, team-oriented environment.

Working closely with the Senior Director, Clinical Trial Managers, Project Managers, Associate Project Managers, and Clinical Research Associates, this position supports a variety of clinical trial activities while ensuring compliance with Good Clinical Practice (GCP), organizational and sponsor Standard Operating Procedures (SOPs), and applicable FDA regulations.

Advanced opportunities may be available for candidates with prior site monitoring experience and the ability to review and evaluate clinical monitoring trip reports.

Key Responsibilities

• Collaborate with investigators, site personnel, Institutional Review Board (IRB) staff, and sponsor/funder representatives to support overall study management and conduct.
• Conduct pre-study activities, remote Site Initiation Visits (SIVs), site closeout visits, and other remote monitoring activities as assigned.
• Assist with site identification and feasibility activities, including developing preliminary site lists, preparing feasibility questionnaires, compiling site responses, and providing recommendations to the Sr CRA and/or Project Manager.
• Prepare site regulatory packet templates and coordinate the distribution, collection, tracking, and review of required regulatory documentation.
• Generate and review database reports to identify missing or incomplete electronic data capture (EDC) information and follow up with monitors and site personnel to facilitate timely data completion and correction.
• Maintain site tracking reports, site contact logs, and study documentation reports as required.
• Provide general clinical research and project support to ensure studies remain organized, compliant, and on track.

Required Experience

• Minimum of three (3) years of oncology clinical research experience.
• Experience in oncology research as a Clinical Research Associate (CRA), Clinical Research Monitor, Auditor, Research Coordinator, Research Associate, or in a similar clinical research capacity.
• Strong organizational, communication, and documentation skills.
• Ability to work collaboratively with internal study teams, clinical research sites, and external stakeholders.

Education

• Bachelor's degree from an accredited college or university required.