Clin/Tran Research Coordinator 1

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Organization:

Neurology Admin 20

Job Summary:

The Behavioral and Cognitive Neurology division is a multidisciplinary research team comprised of professionals dedicated to improving the lives of those with neurodegenerative disorders and their families. The Behavioral and Cognitive Neurology division is seeking a Clinical Translational Research Coordinator I to join the team. The coordinator will be responsible for coordinating the approval processes and conduct of research protocols, such that the integrity and quality of the clinical/translational research is maintained and the research is conducted in accordance within all policies. This is a fully in-person job with potential occasional evening or weekend hours.

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KEY RESPONSIBILITIES

·       Understanding and capability to accurately and compliantly perform the procedures required of each study protocol, working collaboratively with study participants, other staff and departments, in safely and accurately performing study procedures such as assessing participant eligibility and recruitment, arranging necessary schedules and procedures, administering neuropsychological assessments, conducting interviews regarding mental health and quality of life, tracking medication usage, etc.

·       Knowledge and understanding of the implementation, coordination, management and reporting of clinical/translational research operations.

·       Ability to identify and troubleshoot problems.

·       Records data from participant interaction onto case report forms (either paper or electronic) with awareness and attention to the requirements for accuracy, completeness and timeliness. Attends to query resolution in a timely manner.

·       Assures research information is collected and stored in a manner that is compliant with regulations/policies and good clinical practice.

·       Participates in the ongoing informed consent process, ensuring that human subjects, their families, and other health care providers clearly understand what is expected of and from them in the course of participating in a clinical/translational trial.

·       Engages in open communication with participants by providing them with contact information and being available to answer, address or refer their calls.

·       Demonstrates knowledge and understanding of policies, procedures, and regulations governing human subject's research and incorporates them in the conduct of research.

·       Demonstrates knowledge and understanding of the Federal regulations and guidelines governing the protection of human subjects, e.g., FDA, OHRP, GCP/ICH , and HIPAA regulations.

·       Proficiently prepares and processes new IRB research proposals, amendments, continuing review applications and adverse event reports according to institutional and departmental policies and procedures and federal regulations.

·       Accurately and compliantly prepares and maintains documents required to be maintained internally and available for regulatory authorities and/or the sponsor prior to, during and after the conduct of a clinical/translational trial. Participates in periodic site visits from sponsor, regulatory authorities and others to review research, source documentation, and research procedures.

·       Participates in the determination of eligible candidates fo