Clinical Research Coordinator II - Endocrinology and Diabetes
About The Position
The Clinical Research Coordinator II (CRC II) will work with Steve Willi, MD, Director of the Diabetes Center and his team. Dr. Willi’s research focuses on the treatment and delay of progression type 1 and type 2 diabetes in children. Under the direction of Dr. Willi and other team members the CRC II provides support in the conduct of research. Dr. Willi’s conducts multiple clinical trials on new treatment for type 1 and type 2 diabetes. The CRC II will work closely with Dr. Willi from study start-up through recruitment, study visits, monitoring and study close for clinical trials.
Requirements
- Bachelor's Degree Required
- At least two (2) years of clinical/research coordination experience Required
- Basic knowledge of IRB and human subject protection
- Excellent verbal and written communications skills
- Strong time management skills
- Ability to collaborate with stakeholders at all levels
Nice To Haves
- Master's Degree in a related field Preferred
- At least three (3) years of clinical/research coordination experience Preferred
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
- 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
- Coordinate research/project team meetings
- Collect, process and ship laboratory specimens
- Schedule subject visits and procedures
- Retain records/archive documents after study close out
- Manage study finances including sponsor invoicing & resolving study subject billing issues
- Develop advertisement materials
- Act as liaison for research subject, investigator, IRB, sponsor, and healthcare professionals
- Organize and/or run study-related meetings locally or across teams (for multi-site projects)
- Support study team communications and outreach
- Provide training to junior staff on conduct of research studies
- Document investigational product (drug/device) accountability
- Self-monitor and self-audit responsibilities
- Develop informed consent document and/or draft or edit IRB protocols or related documents such as study administration manuals
- Maintain Clinical Trial.gov
- Develop Case Report Forms
- Assignments to include more complex studies
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
