Senior)

Theradex Oncology•Princeton, NJ

6d•$75,000 - $145,000•Hybrid

About The Position

Theradex Oncology is a full-service CRO specializing in oncology, managing global oncology trials and programs. Founded in 1982, the company has a long history of working with the National Cancer Institute and industry sponsors to develop cancer therapeutics. As a service-based company, Theradex supports both domestic and international sponsors in conducting early and late-phase trials. This role offers an opportunity to work with a large professional team focused solely on cancer therapy development, supporting sponsors in the advancement of new therapies and therapeutic approaches. Theradex Oncology is seeking highly motivated individuals who want to make a difference in an evolving field.

Requirements

Bachelor's degree in biological or science-related field (BSc, BA, or RN equivalent) or equivalent experience.
Experience as a Clinical Research Associate with experience managing clinical trial sites.
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
Ability to travel up to 50% may involve overnight stays.
Valid Driver’s License required
Successfully pass background clearance checks which may be run on a periodic basis due to 3rd party contractual obligation requirements.
Fluent in English (written and verbal)

Nice To Haves

Passport preferred

Responsibilities

Conduct Site Monitoring: Site Qualification visits, Site Initiation visits, Routine Monitoring visits, Close-out visits
Manage all aspects of site management as described in the study plans
Source document verification: 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)
Site Management: 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