In House Clinical Research Associate (IHCRA - Oncology Studies)

Job Description

Job Description

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.

 

Company Description

The Coalition of Cancer Cooperative Groups is a unique nonprofit organization with one mission, improving patient awareness of cancer clinical trials, facilitating access, and promoting participation. Through innovative programs and services, the Coalition examines and confronts key issues impeding cancer research.

The Coalition of Cancer Cooperative Groups was established in 1997 to address improving the cancer clinical trials system. Today, the Coalition is comprised of members from National Cancer Institute-sponsored Cooperative Groups, the country's leading patient advocacy organizations, and thousands of oncology and cancer research specialists. The Coalition also works with its partners in the healthcare industry to streamline and promote cancer clinical trials in both the public and private sectors.

Company Description

The Coalition of Cancer Cooperative Groups is a unique nonprofit organization with one mission, improving patient awareness of cancer clinical trials, facilitating access, and promoting participation. Through innovative programs and services, the Coalition examines and confronts key issues impeding cancer research.\r\rThe Coalition of Cancer Cooperative Groups was established in 1997 to address improving the cancer clinical trials system. Today, the Coalition is comprised of members from National Cancer Institute-sponsored Cooperative Groups, the country's leading patient advocacy organizations, and thousands of oncology and cancer research specialists. The Coalition also works with its partners in the healthcare industry to streamline and promote cancer clinical trials in both the public and private sectors.