Title Clinical Research Associate; CRA I​/II​/Senior

Theradex is an Equal Opportunity Employer.

US-NJ-Princeton | US

Category Clinical Research Associates (Commercial)

Type Full Time

Celebrating 40+ years!

Theradex Oncology is a full-service CRO specializing in oncology. The company manages global oncology trials and programs. The company was founded in 1982 working with the National Cancer Institute, which led to its expansion to working with industry sponsors developing cancer therapeutics. As a service-based company we support both domestic and international sponsors in the conduct of both early and late phase trials.

As part of Theradex Oncology, you will have the opportunity to work with one of the largest professional teams focused solely on the development of cancer therapies. Cancer research continues to evolve as new therapies and therapeutic approaches are discovered, as part of the team you will the work to support our sponsors in the development of these therapies. Theradex Oncology is an environment for highly motivated individuals who want to make a difference.

We are expanding our team and are looking to hire CRAs for onsite and remote monitoring of phase l-lll oncology studies.

The primary responsibilities of this position include, but are not limited to, the following:

• Site Qualification visits
• Site Initiation visits
• Routine Monitoring visits
• Close-out visits
• All aspects of site management as described in the study plans

• Verify patient eligibility
• Reviews consent process for each subject (Informed Consent Form and source documentation)
• Assess protocol compliance and deviations
• CRF review and data corrections
• IMP accountability
• Maintenance of on-site investigator files
• IEC/IRB documentation
• Local laboratory documentation
• Maintenance of investigational supplies
• Identify and assess safety issues and reporting (SAEs/AEs)

• Ensure protection of participants and participants' rights
• Proactively identify and resolve actual and potential site and study issues
• Ensure clinical data integrity and adherence to study timelines
• Clinical Review of individual patient listings
• Assist in the preparation of project specific materials e.g., status reports, newsletters, templates, etc.
• Act as the routine liaison between study site and the project team for study related issues
• Perform other duties as assigned by management

• At minimum, Bachelor's degree in biological or science-related field (BSc, BA, or RN equivalent) or equivalent experience.

• As a Clinical Research Associate with experience managing clinical trial sites, the number years and type of monitoring experience will determine CRA level.
• Experience in monitoring oncology studies is preferred
• Experience monitoring oncology Phase I-III studies required for Sr CRA consideration

• Knowledge of ICH/GCP Guidelines, and Regulatory requirements
• Ongoing development of cancer therapy knowledge, clinical trial design and conduct, and drug development process through work experience, literature reviews and other educational opportunities
• Proficient in Excel, PowerPoint, Word, and Outlook
• Skilled remote collaboration and teleconferencing platforms
• Strong organizational skills, including efficiency, punctuality, and collaboration in a team environment.
• Effective communication skills: verbal and written
• Strong interpersonal skills including presentation, persuasion, and influence

• This position involves travel as needed to meet study requirements. Ability to travel up to 50% may involve overnight stays.
• Valid Driver's License required and Passport preferred
• Successfully pass background clearance checks which may be run on a…