Clinical Research Coordinator – Hematologic Malignancies Program

SHIFT:

Day (United States of America)

Clinical Research Coordinator II

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A Brief Overview
Hematologic malignancies including leukemia are forms of cancer that begin in the immature white cells of blood-forming tissues including bone marrow and the immune system. Researchers at the Center for Childhood Cancer Research are using state-of-the art genomic, immunotherapeutic and targeted molecular approaches to develop new therapies to treat pediatric leukemias and related hematologic malignancies. The ability of researchers at the Center for Childhood Cancer Research to quickly translate laboratory-based discoveries
into clinically relevant therapies offers enormous promise for children with leukemias and other hematologic malignancies.
 

The Hematologic Malignancies Program is seeking a proactive and team-oriented CRC II to coordinate its portfolio of early-phase clinical trials testing novel agents in children with relapsed/refractory leukemias. Responsibilities will include patient identification, eligibility assessment for clinical trial participation, biospecimen coordination and shipping, and involvement in the consent process when appropriate. The coordinator will assist with data management for clinical trials and support other clinical research efforts of faculty members in the Hematologic Malignancies Program. The CRC II will participate in biweekly early phase clinical trials group research meetings and weekly clinical Hematologic Malignancies Program meetings. The CRC II will report to the Hematologic Malignancies Program manager and the Hematologic Malignancies section chief, as well as to the Division of Oncology Administrative Manager of Clinical Research and will work closely with several pediatric oncology faculty members in the Hematologic Malignancies Program.

Must be knowledgeable on, have full understanding of, and promote good clinical practices (GCP) and will be held accountable for adherence to all policies and procedures surrounding these processes and for maintaining up to date knowledge on these policies from IRB, FDA, ICH, GCP, or other sources.

What you will do

• Core responsibilities
• Adhere to an IRB approved protocol
• Participate in the informed consent process of study subjects
• Support the safety of clinical research patients/research participants
• Coordinate protocol related research procedures, study visits, and follow-up care
• Screen, recruit and enroll patients/research participants
• Maintain study source documents
• Report adverse events
• Understand good clinical practice (GCP) and regulatory compliance
• Educate subjects and family on protocol, study intervention, etc.
• Comply with Institutional policies, standard operating procedures (SOPs) and guidelines
• Must comply with federal, state, and sponsor policies
• Related responsibilities
• Prepare, manage, submit, and maintain essential regulatory documents (e.g. IRB, FDA, etc.) and remain aware of the regulatory status for projects within scope of role
• Register study on ClinicalTrial.gov as appropriate
• Complete case report forms (paper & electronic data capture) and address queries
• Facilitate pre-study, site qualification, study initiation, and monitoring visit as appropriate
• Facilitate study close out activities as appropriate