Note: The job is a remote job and is open to candidates in USA. Theradex Oncology is a full-service CRO specializing in oncology, managing global oncology trials and programs. The Clinical Research Associate (CRA) will be responsible for onsite and remote monitoring of phase I-III oncology studies, ensuring participant protection, data integrity, and compliance with study protocols.
Responsibilities
- Conduct Site Monitoring:
- Site Qualification visits
- Site Initiation visits
- Routine Monitoring visits
- Close-out visits
- 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
Skills
- 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 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
- 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)
- Experience in monitoring oncology studies is preferred
- Valid Passport preferred
Benefits
- Medical, dental and vision coverage
- Life insurance
- Disability insurance (STD/LTD)
- Company matched 401(k)
- Very competitive tuition reimbursement
- Generous vacation/sick plans
- Flexible work schedules
- Employee discounts
- Other company provided benefits
Company Overview