Coordinates the clinical, regulatory, business, and other research- related activities and documentation for clinical trials conducted, follows industry standards and applicable regulations including FDA/OHRP guidance, GCP and ICH. The Research Coordinator is responsible for collecting, evaluating, analyzing, planning, conducting, and reporting all data management for the TCT program. The Oncology Research Coordinator is responsible for accurate and timely submission of data to reporting agencies and works in collaboration with the department and leadership team.
- Coordinates clinical and regulatory document submissions for clinical trial start-up, consent development and amendment, protocol amendment, continuing review, closure to accrual, action letter, suspension, termination, and other reportable regulatory information.
- Assesses patient eligibility through chart reviews and patient/family interviews as appropriate.
- Collaborates with regulatory team, Principal Investigator, Sub-Investigators, study personnel, IRB, and the biostatistics department in physician projects. The Research Coordinator will work collaborative with the physicians on project outlines, follow up meetings, and project updates related to the assigned project.
- Presents and obtains patient informed consent.
- Coordinates accurate data collection and record keeping by reviewing documents and processes for quality assurance and ensures timely and accurate submission of data.
- Collects, reviews, and analyzes statistical data for the program.
- Completes and submits patient data to the Center for International Blood and Marrow Transplant Research (CIBMTR).
- Completion of CRF (CRFs) maintaining a high level of accuracy.
- Meets productivity and quality standards for data submission.
- Completion and resolution of queries from reporting agencies.
- Coordinates and prepares for internal and external audits.
- Proactively works with Clinical Transplant Nurse Coordinators, referring physician offices, and other departments to obtain information required to complete assigned forms.
- Utilizes clinical application to organize workload and communicate current status of assigned forms.
- Maintains adequate knowledge of Hematology and Bone Marrow Transplant and new therapy developments.
- Must be able to work under pressure to meet deadlines.
- Assists in the development, improvement and review of Standard Operating Procedures and processes.
- Provides educational and technical assistance to research staff including orientation and mentoring of new research teammates.
Primarily works in an office setting. Requires full range of body motion; sitting for extensive periods of time; walking, standing, reading, and writing/keyboarding. Occasionally lifts and carries items weighing up to 35 pounds. Requires corrected vision and hearing within normal range. Must speak and read/write clearly in English. Must be able to be mobile within the entire healthcare system and other locations that participate in LCI clinical trials.
Bachelor's Degree and 1 year of clinical research experience with a pharmaceutical company or Contract Research Organization (CRO) or equivalent experience required; or Master's Degree and 0-1 year of clinical research experience with a pharmaceutical company or Contract Research Organization (CRO) or equivalent experience required; or a minimum of 3 years clinical research experience with a pharmaceutical company or Contract Research Organization (CRO) or equivalent experience required with no degree. Health/Science degree preferred. Previous experience in a healthcare setting preferred, especially cancer care and/or clinical research. Certification in clinical research (SoCRA, ACRP, RAPS, etc.) preferred.
Education, Experience and Certifications
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