What are the responsibilities and job description for the Clinical Research Associate ( CRA I or II Depending on Experience) position at Theradex Oncology?
Who We Are:
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 You'll Do:
Our team is expanding. We are seeking a CRA (I or II) depending on experience. As a CRA, you'll conduct site visits to academic and non-academic cancer centers in compliance with the monitoring guidelines of the NCI Experimental Therapeutics Clinical Trials Network. You'll also, accompany NCI CTMS Project Manager or Senior Clinical Research Associates on specific types of site visits as assigned by the NCI CTMS Project Manager. You'll interact with all levels of company personnel, including but not limited to all NCI CTMS personnel, NCI Clinical Trials Monitoring Branch personnel, study investigators and site personnel.
Key Responsibilities:
Experience Required:
Additional Requirements:
We offer a supportive culture that puts people first. We provide a competitive compensation and benefits package including medical, dental, vision, life insurance, short-term/long-term disability (STD/LTD), company matched 401(k), very competitive tuition reimbursement, generous vacation/sick plans, flexible work schedules, employee discounts and much more.
Theradex is an Equal Opportunity Employer.
Theradex is not utilizing agencies for this role. Unsolicited resumes will not be accepted.
Celebrating 40 Years!
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.
Would you like to progress your clinical research career as a Clinical Research Associate (CRA)?
Our team is expanding. We are seeking a CRA (I or II) depending on experience. As a CRA, you'll conduct site visits to academic and non-academic cancer centers in compliance with the monitoring guidelines of the NCI Experimental Therapeutics Clinical Trials Network. You'll also, accompany NCI CTMS Project Manager or Senior Clinical Research Associates on specific types of site visits as assigned by the NCI CTMS Project Manager. You'll interact with all levels of company personnel, including but not limited to all NCI CTMS personnel, NCI Clinical Trials Monitoring Branch personnel, study investigators and site personnel.
Key Responsibilities:
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Monitors NCI-sponsored investigational drug studies, primarily Phases I and II including:
- Source document review and comparison to case report form (CRF) data
- CRF review, issue data queries, ensure data corrections have been made,
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Investigational Pharmacy Reviews (e.g., inspection of pharmacy facilities, review of pharmacy standard operating procedures, drug storage conditions, drug dispensing, etc.).
- Maintenance of on-site investigator files
- Regulatory documentation review (e.g., IRB documentation of initial protocol approval, IRB amendment approvals, content of informed consent forms, delegation task logs, etc.)
- Local laboratory documentation
- Handling of serious adverse event report
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Conducts site contacts, including:
- Data Audits and Annual site (monitoring) visits
- Cancer Center Site Visits (i.e., compliance audits
- Reviews compliance with protocol for each subject (i.e., consent process, eligibility, treatment, adverse event reporting, disease outcome and general data management quality)
- Monitors performance of assigned sites, including but not limited to site progress in implementing corrective and preventative action plans and progress in decreasing the incidence of major and lesser deficiencies.
- Contributes to other projects as assigned by the NCI CTMS Project Manager. Additional assignments could include, but not be limited to, performing selected functions of the Clinical Research Associates who support non-NCI sponsored clinical trials. These responsibilities could include, but not be limited to, case report form review, review of consent process, verify patient eligibility, and conduct of selected on-site visits.
Level of Education Required:
- Bachelor's degree (BSc, BA, or RN equivalent) in biological or science-related field.
- Advanced degree preferred.
Experience Required:
- Minimum 2 years pharmaceutical industry/CRO/academic experience in a clinical research position
- Academic clinical oncology experience is highly preferred
- Prior project management/study coordinator experience preferred
Skills and Competencies:
- Thorough knowledge of current Federal regulations and applicable guidelines and guidance, particularly those dealing with pharmacovigilance, study monitoring and good clinical practice.
- Thorough knowledge of the initiation, conduct, and completion of phase I-II clinical trials
- Highly organized and result-oriented
- Highly effective ability to anticipate problems relating to projects and to develop and implement solutions
Additional Requirements:
- Ability to travel up to 50%, primarily in the U.S. and Canada
- Valid Driver’s License
- Fluent knowledge of written and verbal English
What We Offer
We offer a supportive culture that puts people first. We provide a competitive compensation and benefits package including medical, dental, vision, life insurance, short-term/long-term disability (STD/LTD), company matched 401(k), very competitive tuition reimbursement, generous vacation/sick plans, flexible work schedules, employee discounts and much more.
Theradex is an Equal Opportunity Employer.
Theradex is not utilizing agencies for this role. Unsolicited resumes will not be accepted.
