The CRC III will coordinate the daily operations of multiple clinical trials related to leukodystrophies, a group of rare genetic disorders that affect the development and maintenance of the brain’s white matter. Located within the lab of Adeline Vanderver, MD, the CRC III will be primarily responsible for managing studies that offer treatment options to individuals diagnosed with Aicardi Goutieres Syndrome (AGS), a specific type of leukodystrophy. Under the direction of Dr. Vanderver,http://www.chop.edu/doctors/vanderver-adeline the CRC III will be required to successfully implement study protocols within the framework of institutional, federal, and industry requirements.
The CRC III functions independently in a clinical research setting and is responsible for the complete coordination of assigned clinical research activities within the scope of clinical research protocols. The CRC III will interact regularly with the research staff, physicians, and clinical staff in CHOP’s LCE http://www.chop.edu/centers-programs/leukodystrophy-center to support the enrollment and follow-up of clinical trial participants. This is a high-volume, fast-paced research group, and prior experience working in an industry or academic research environment is strongly preferred.
The CRC III serves as resource and primary contact for other study team members, Principal Investigator, physicians, clinical staff, internal and external oversight groups, sponsors, ancillary staff, participants and their families. The ideal candidate will have a passion for scientific learning, and a desire to embrace challenging and rewarding opportunities. The CRC III should possess strong personal ethics, good communication skills, attention to detail, flexibility, operational knowledge, critical thinking skills, clinical competency, and problem solving skills.
The CRC III is responsible for the following:
Applies in depth knowledge of clinical research and independently coordinates the activities of 1 or more large-scale, complex multi-center / multi-institutional studies
Manages the protocol and regulatory board submissions
Participates in the informed consent process of study subjects
Screens, recruit and enroll patients/research participants
Collects and analyze data and complete case report forms
Prepares study sites for internal/external regulatory audits/monitoring (sponsor, FDA, NIH, etc.)
Facilitates and/or leads research/project team meetings
Educates and mentors internal and external clinical staff, research teams and other coordinators; provides resources, and consulting on difficult protocols or projects