Clinical Research Assistant II-Rheumatology
Full Time
Boston, MA 02115
Posted
Job description
Job Summary
The Clinical Research Assistant II will lead a team of research assistants in the Rheumatology Section within the Division of Immunology to coordinate a broad portfolio of projects related to understanding and improving outcomes of children living with rheumatic conditions, including but not limited to lupus, juvenile arthritis, autoinflammatory conditions, and vasculitis.
This Clinical Research Assistant II will be responsible for:
The Clinical Research Assistant II will lead a team of research assistants in the Rheumatology Section within the Division of Immunology to coordinate a broad portfolio of projects related to understanding and improving outcomes of children living with rheumatic conditions, including but not limited to lupus, juvenile arthritis, autoinflammatory conditions, and vasculitis.
This Clinical Research Assistant II will be responsible for:
- Assist Principal Investigators (PIs) in onboarding new clinical research studies, including clinical trials
- Distribute weekly research assistant responsibilities among members of the research coordinator team, including screening, clinic recruitment and biosample collection
- Assist with recruiting and consenting study participants
- Oversee database management for clinical research studies and assist with data entry
- Manage the agenda for weekly research coordinator team meetings
- Assist in preparation of IRB protocol submissions and amendments
- Maintain regulatory binders, source documents, and study supplies
- Assist with administrative aspects of study management, including keeping track of invoices
- Perform annual internal study audits and ensure compliance with all institutional policies and government regulations pertaining to human subjects protections
- Recruiting study participants for enrollment in clinical studies, including organizing strategies for recruiting study participants, screening study participants for eligibility, and completing informed consent procedures
- Organizing study procedures and scheduling study participants for study visits. Assisting the PI during study visits
- Coordinating off-site visits, including travel arrangements; attending off-site visits
- Completing record abstraction of source documents, conducting required study measurements and completing study Case Report Forms (CRFs); conducting a QC check of completed CRFs prior to submission for data entry; coordinating resolution of all data queries
- Maintaining regulatory binders, case report forms, source documents, and other study documents; monitoring the occurrence of adverse events and reporting to the PI, the study sponsor and the IRB, if any
- Collection or processing of study specimens, delivery to appropriate labs or packaging and shipping to appropriate facilities
- Assisting PI and other study staff with conference presentations and manuscripts by extracting and compiling data from investigator-initiated studies
- This position may offer candidates an opportunity to shadow physicians and other healthcare providers in an academic medical center
- Have a bachelor's Degree and one year of research experience
- Strong organizational skills and attention to detail
- Effective communication and leadership skills
- Adaptable to do work that is varied and requires an intellectual and professional approach
- Proficiency with Microsoft Office
- Prior Experience with IRB submissions is preferred
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