Req ID: 18199
Employment Status: AF - Active - Regular - Full Time
Nephrology divison is seeking a CRC I to hold the responsibility of screening, recruiting and enrolling patients in research and implementing study procedures according to protocol. The CRC I will be frequently responsible for the day-to-day management of current research projects using web-based mobile-health platforms and entering sensitive patient information into databases and registries. An ideal candidate is empathetic to patients and families, highly organized, diligent, pays attention to detail, and has strong computer skills.
Under moderate supervision, coordinates all clinical research activities within the scope of clinical research protocols.
The CRC I is expected to perform all CRC Core responsibilities (as applicable):
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.
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.
Also may be responsible for any of the following:
Manage essential regulatory documents
Register study on ClinicalTrial.gov
Complete case report forms (paper & electronic data capture) and address queries
Submit documents to regulatory authorities (e.g. IRB, FDA, etc.) and/or review/monitoring boards (ie, DSMB, independent safety officer)
Facilitate study close out activities
Coordinate research/project team meetings
Collect, process and ship laboratory specimens
Schedule subject visits and procedures
Retain records/archive documents after study close out