Summary

The Senior Research Coordinator, will independently lead day to day operations of various complex clinical research studies. The selected candidate will be responsible for assisting investigators in the overall conduct of clinical trials, coordinating and overseeing day to day activities of research protocols for the Childhood Arthritis and Rheumatology Research Alliance (CARRA) study, immune-mediated CNS disorders, along with maintaining regulatory affairs for four national registries, multi-center projects, and all investigator-initiated section studies. This includes screening, enrollment, assisting with questionnaire forms, extracting data from medical records review protocols, review study materials, and ensuring compliance with IRB approved protocols and monitoring of research participants, ensure accurate data collection, documentation, organization, and safety of research participants. The Senior Research Coordinator, will require advanced knowledge of clinical research, strong organizational skills, operate independently with minimal oversight. This is leadership position, in which the applicant will be expected to oversee, train and mentor junior Research Coordinators. Will be responsible for managing high level and complex clinical studies.

Job Duties

• Manages patient enrollment (recruiting, screening and interviewing) and study consent process of patients
• Maintains regulatory files current. • Trains and mentors lower level research coordinators.
• Completes IRB submissions and responds to requests and questions with central and local IRBs.
• Interacts with study sponsors and monitors • Provides leadership for all studies/trials assigned, develop and implements policy and procedures and identifies and implements corrective actions/process when required.
• Oversees data management of studies ensuring accurate study subject documentation.
• Enterrs subject data into all required electronic data collection system.
• Manages and enters information in CTMS (clinical trial management system) database.
• Collects patient information; processes documents and enters information into a database.
• Collects, process, ship, and maintain paperwork for blood and/or biological specimens according to procedures outlined in study protocol.
• Maintains records and regulatory documents for all research studies in the section.
• Schedules research participant for tests and procedures such as laboratory tests, x-rays, and other studies specific for the research protocol.
• Retrieves and submits test results to appropriate party.
• Corresponds with patient throughout study.
• Orders supplies and equipment.

Minimum Qualifications

• Bachelor's degree in a Basic Science or related field. Four years of related experience may substitute for degree requirement.
• Five years of relevant experience.