Clinical Research Coordinator I - Rheumatology
About The Position
Clinical Research Coordinator opening in the Division of Rheumatology for projects related to ocular inflammatory disease. The Research Coordinator will play a key role in research projects under the direction and guidance of 1 Principal Investigators, 2 co-PIs and will also be part of a larger Rheumatology research core. This person will be a collaborative member of our team and will help to develop a research portfolio focused on understanding and improving outcomes for children with uveitis and other oculoinflammatory diseases. The Research Coordinator will work on both primarily clinical research as well as translational science projects. The ideal candidate will have training in data science and statistical analysis and a background /interest in machine learning using imaging data. The candidate should understand research practices and Institutional Review Board (IRB) procedures. This person will need to exercise discretion and judgment in execution of research protocols, analysis of data, and general project support.
Requirements
- High School Diploma / GED Required
- At least two (2) years of clinical or research related experience Required
- Basic knowledge of IRB and human subject protection
- Strong verbal and written communications skills
- Strong time management skills
- Ability to collaborate with stakeholders at all levels
Nice To Haves
- Bachelor's Degree Preferred
- At least three (3) years of clinical or research related experience Preferred
- Training in data science and statistical analysis
- Background /interest in machine learning using imaging data
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
- Under the supervision of PI 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, and with HIPAA and management of confidential materials
- Must comply with federal, state, and sponsor policies
- For multi-site studies or collaborations, support communication and meeting scheduling across teams
- Manage essential regulatory documents
- Register study on ClinicalTrials.gov as appropriate
- 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 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 samples as applicable to the protocol
- Schedule subject visits and procedures
- Retain records/archive documents after study close out
- Conduct literature searches and article retrievals
- Perform clinical research involving patient enrollment and coordination of study visits
- Collect patient samples (tears)
- Develop data management system
- Perform data entry, retrieval and analysis
- Be responsible for overseeing data sharing with external collaborators, including transfer images to a shared drive
- Participate in research meetings to gain a better understanding of protocol issues and project developments
- Assist in preparation of grants, IRB documents, manuscripts and presentations
- Assist in overseeing and coordinating student research assistants
Benefits
- Annual influenza vaccine
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
