Clinical Research Coordinator II – Autism & Developmental Disorders Research Program

Summary

POSITION SUMMARY

• Make a difference by working in clinical research studies of children with autism and other developmental disabilities. This position will coordinate the activities of enrollment and data collection for a range of protocol designs to ensure participant safety and protocol compliance in accordance with the code of federal regulations and good clinical practice

ESSENTIAL FUNCTIONS

Study Coordination

• Identify, screen and interview potential study subjects and their families.
• Conduct the informed consent process with potential participants and their families. This includes explaining the project and all associated benefits/risks, answering any questions, obtaining signatures on legal documents and providing continual informed consent throughout protocol participation.
• Ensure the safety and protection of subjects enrolled in a research study.
• Schedule subject assessments/visits as necessary.
• Assure all study tests, visits, and assessments are done at appropriate time intervals.
• Biospecimen sample collection and processing (such as blood, saliva, etc.)
• Observe participants and review medical records to record required protocol data and document protocol adherence
• Assess subjects for signs of potential adverse events. Report all suspected adverse events to the appropriate personnel/regulatory agencies.
• Complete case report forms by obtaining, compiling, and maintaining necessary documentation.
• Facilitate studies by coordinating study related activities with other departments and staff.

Compliance and Audit Coordination

• Comply with FDA regulations and International Conference on Harmonization(ICH)/Good Clinical Practice (GCP) guidelines for conducting clinical trials.
• Coordinate and maintain regulatory documents, including the Institutional Review Board (IRB) application, research plan and writing the informed consent.
• Facilitate inspections and audits from industry personnel and regulatory agencies including internal reviews.
• Demonstrates competency in informed consent.
• Certification by the Association of Clinical Research Professionals or Society of Clinical Research Associates expected within two years of hire.

Collaboration

• Provide day to day support to Clinical Research Coordinator I roles on the Autism and Developmental Disorders research team
• Develop collaborative relationships with Spring Harbor Hospital personnel and other external organizations in the support of conducting active research protocols
• Be a primary resource to Clinical Research Coordinators from outside institutions that are part of the Autism and Developmental Disorders Inpatient Research Collaborative (ADDIRC)
• Collaborate on the design of departmental research projects.
• Collaborate in the development of research related data collection methods. This includes designing case report forms, and associated databases.

Communication

• Interact with industry and community personnel involved with potential and ongoing scientific research.
• Coordinates activities of the Autism and Developmental Disorders Inpatient Research Collaborative (ADDIRC). This includes orienting new research coordinator members, scheduling meetings, setting agendas, facilitating network CRC meetings and keeping minutes.

Required Minimum Knowledge, Skills, and Abilities