Clinical Research Coordinator II - Rheumatology
About The Position
The Division of Rheumatology, in close collaboration with the Divisions of Oncology, Immunology, and Gastroenterology, has launched a Cellular Therapy Program designed to offer curative approaches to autoimmune and other disorders of immune dysregulation. The focus is on the use of CART-19 therapy for autoimmune diseases such as lupus, dermatomyositis, and scleroderma in children and young adults. This role has a strong emphasis on teamwork and close collaboration with the CAR T cell research team within the Division of Oncology. Under minimal supervision, this role substantially coordinates all clinical research activities within the scope of clinical research protocols. Duties involve managing the day-to-day activities of the research study under the guidance of PI, coordinating multidisciplinary study visits, data collection, data management, regulatory oversight, adverse event reporting, and sponsor communication. Skills required include study management, strong communication skills, problem solving, and patient/family communication. This is an extremely exciting time as the field of cellular therapies for autoimmunity is in its infancy - we anticipate lots of growth!
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
Benefits
- Annual influenza vaccine
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
