Oncology Clinical Research Associate II - Onsite Monitor
About us: Theradex Oncology is a full-service CRO, conducting early and late-phase oncology trials in the U.S, Europe and Asia. Theradex Oncology was founded in 1982, when we were awarded the Clinical Trials Monitoring Contract for the National Cancer Institute (NCI). Our ongoing association with NCI continues to be a strong basis for our operations. Our focus is cancer. We fully understand the science behind each potential cancer therapy and the challenges that come with moving therapies from mice to man. Theradex Oncology has designed and managed more than 250 early and late-phase oncology trials to date. Our mission is to assure that new discoveries in cancer drug development have the very best opportunity to be of benefit to mankind with a vision to improve treatment and make cancer a livable disease.
What we offer:
We offer a supportive culture that puts people first. We provide a competitive compensation and incentive plan. Our benefits package includes medical, dental, vision, life insurance, STD/LTD, 401(k), tuition reimbursement, generous vacation/sick plans, flexible work schedules, employee discounts and much more.
What you’ll do:
As our CRAII, you will act as the routine liaison between study site and the project team for study related issues. You will conduct pre-qualification, initiation, routine monitoring, and close-out visits in accordance with the relevant SOPs. In addition, you will insure protection of subjects, subjects' rights, and the integrity of data through monitoring of adherence to Good Clinical Practice, applicable regulatory requirements, Standard Operating Procedures, and protocol compliance
• Proactively identify and resolve issues and potential site and study issues.
• Assist with regulatory and study start-up activities including contract and budget negotiations, as required.
• Ensure clinical data integrity and meet study timelines.
• Provide ongoing updates and support to project management.
• Mentor junior members of the team.
• Prepare and deliver staff training sessions.
• Clinical Review of individual patient listings
• Initial clinical review of comprehensive patient data listings
• Initial review of study start-up materials: SOPs, draft CRFs, completion manual, compliance forms, study prompters/calendars
• Assist in the day to day running of projects assigned.
• Assist in the preparation of project specific materials e.g., status reports, newsletters, templates, etc.
• Participate in project administration as required e.g., photocopying, binder preparation, start-up pack preparation etc.
• Maintain an awareness of the literature on cancer therapy, clinical trial design and conduct, and good clinical practice.
• Perform other duties as assigned by management
What you need: Prior Experience Required
• At minimum, Bachelor's degree (BSc, BA, or RN equivalent) in biological or science-related field or equivalent experience.
• To qualify you must have demonstrative CRA experience working directly for a CRO, pharmaceutical/biotech company.
• At least 2 years’ experience as a Clinical Research Associate with a sound track record in managing clinical trial sites.
• Experience in monitoring oncology early phase studies.
• Travel: This position requires the ability to travel approximately 70% of the time domestically and/or internationally and may involve overnight stays.
• Valid Driver’s License and Passport preferred
Skills and Competencies to be demonstrated:
• Thorough knowledge of ICH Guidelines and GCP including an understanding of regulatory requirements.
• Demonstrable multitasking and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.
• Good organizational skills, including efficiency, punctuality, and collaboration in a team environment.
• Knowledgeable in the identification, anticipation, and reporting to appropriate management problems relating to study conduct and effective in developing solutions to those problems
• Effective knowledge of the drug development process
• Fluent in English - Good communication skills: verbal/written
• Proficient knowledge of Outlook, Word, and Excel
This job does not offer company sponsorship or relocation assistance.
Preference will be given to qualified candidates residing or willing to reside in AZ, CO or the East North Central States, preferably Greater Chicago, IL.
Valid through: 8/20/2020