Associate Clinical Research Specialist Jobs in Kansas

Experience in clinical research protocols, reporting, regulatory submissions, development of monitoring/analysis/data management plans with technical support

Strong written, oral, and interpersonal communication skills including proficient knowledge of medical terminology

Ability to identify customer requirements and manage expectations for clinical studies

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES

Strong knowledge of World Health Organization (WHO) Good Clinical Practice (GCP) and International Conference on Harmonization (ICH)

Working knowledge of clinical research methods and practices for medical devices, including IDE and CE Mark studies.

Advanced site monitoring; study site management; and registry administration skills.

Thorough knowledge of ICH Guidelines and understanding of local regulatory requirements

Thorough knowledge of monitoring procedures; Basic understanding of the drug accountability process

Good planning, organization and problem-solving abilities; Ability to work with minimal supervision

Organize and make presentations at Investigator Meetings

Participate in the development of protocols and Case Report Forms and clinical trial reports as assigned

Appropriate life-science or healthcare-related qualification or experience or equivalent work experience.

Participates in the study startup activities and site opening activities as well as study conduct and site closure tasks.

Demonstrated business ethics and integrity.

Participate in the monitoring functions in a clinical study including site management, qualification, initiation, routine monitoring, and final close out.*

Assist Clinical management with the development, negotiation, and execution of the site contract, budget, and payment plan.*

Provide mentoring to junior staff regarding protocols, site management/monitoring,etc.*

Assist Clinical management with regulatory submissions, and other reports as required.*

Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. *

Draft informed consents with supervision from line manager.*