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
We have an entry level Data Management Coordinator (Clinical Trials) to join our US CTMS data management team. Our headquarters are based in Princeton, NJ and this role can be remote or onsite. The ideal candidate has 1-2 years work experience in data management in a clinical research environment.
The primary responsibilities of this position include, but are not limited to, the following:
- Review incoming data for completeness, accuracy, patient eligibility, and protocol compliance in Rave® EDC; clinically review patient data; write and resolve data queries; assist site personnel with case report form and query completion; contact sites as needed; follow up on serious adverse event discrepancies
- Prepare SAE and query summary reports for the CRAs prior to site visits. Review data audit discrepancies provided by CRAs following site visits prior to submitting visit report to sponsor
- Assist in preparation of eligibility checklists, protocol abstracts, and protocol code lists as required for new or amended CTMS monitored protocols
- Provide back-up support to the Senior Data Management Coordinator for the following:
- Track severe adverse events (SAEs) reported to CTEP AERS using the CTMS SAE Tracker and/or system updates. Interface with site personnel regarding CDS guidelines as related to reporting SAEs
- Rave® eCRF and OPEN enrollment form development and configuration after additional training (from Medidata and caDSR) has been taken.
What You Need
- Bachelor’s degree, preferably in a science related field. RN or RN BSN preferred.
Skills and Competencies:
- Highly effective ability to anticipate problems relating to projects and to develop and implement solutions
- Excellent interpersonal skills
- Fluent knowledge of written and verbal English
- Highly organized and result-oriented
- Ability to work independently as well as in a team environment
- Proficient in Word and Excel
- 5% domestic travel
- Relocation Assistance and company provided sponsorship is not provided for this position.
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, STD/LTD, company matched 401(k), very competitive tuition reimbursement, generous vacation/sick plans, flexible work schedules, employee discounts and much more.