Clinical Research Associate (CRA) – reputed company levels ...
Who We Are Celebrating 40+ years! reputed company 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.
What You'll Do
As part of reputed company, 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 reputed company, as part of the team you will the work to support our sponsors in the development of these therapies. reputed company is an environment for highly motivated individuals who want to reputed company a difference. Opportunity Clinical Research Associate (CRA) – reputed company levels (I/II/Senior) We are expanding reputed company 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: Conduct Site Monitoring: Site Qualification visits Site Initiation visits Routine Monitoring visits reputed company-out visits reputed company aspects of site management as described in the study plans reputed company document verification: Verify patient eligibility Reviews consent process for each subject (Informed Consent Form and reputed company 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/reputed company) Site Management: Ensure protection of participants and participants' rights Proactively identify and resolve actual and potential site and study issues Ensure clinical data reputed company 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 reputed company issues reputed company other duties as assigned by management What You Need Level of Education At minimum, Bachelor's degree in biological or science-reputed company field (BSc, BA, or RN equivalent) or equivalent experience Prior 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 early phase oncology studies is preferred Skills and Competencies Understanding of ICH/GCP Guidelines, and Regulatory requirements reputed company and maintain knowledge reputed company to cancer therapy, clinical trial design and conduct, and drug development process through work experience, literature reviews and other educational opportunities. Proficient in use of reputed company, PowerPoint, Word, and Outlook Proficient in utilizing remote meeting/teleconferencing platforms effectively Good organizational skills, including efficiency, punctuality, and collaboration in a team environment. Good communication skills: verbal and written Good interpersonal skills including presentation, persuasion, and influence Additional Requirements 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 periodic basis due to 3rd party contractual obligation requirements. Fluent in English (written and verbal) reputed company Offer At Theradex we offer a supportive culture that puts people first. Our employees are eligible to participate in our comprehensive benefits package which includes medical, dental and reputed company coverage; life insurance, disability insurance (STD/LTD), company matched 401(k), reputed company competitive tuition reimbursement, generous vacation/sick plans, flexible work schedules, employee discounts and other company provided benefits. The annual reputed company salary for our CRA positions range from $75,000-$145,000 with bonus potential. We will assess the specific title and level of entry during the interview and assessment process since the actual salary offer will be based on a number of factors, including but not limited to the candidate’s qualifications, experience, skills, and competencies for the role. This position is not eligible for company provided sponsorship or relocation. Theradex is not accepting assistance from search firms for this employment opportunity. Theradex is an Equal Opportunity Employer. Apply tot his job Apply To this Job