Research Project Coordinator

Responsibilities

• Maintains an environment of safety for patients, self and others.
• Recruit, screen, and enroll study subjects in research studies under supervision of clinical research nurse.
• Obtains written informed consent with appropriate HIPAA authorization from each patient prior to study enrollment under supervision of clinical research nurse.
• Prepares subject files ahead of sponsor audits; supports monitoring visits and regulatory inspections of records and documents.
• Completes Study Start Up Project Coordination for all new studies in start-up phase, as well as ongoing project coordination for each study’s life cycle.
• Special Projects Coordination (i.e. COC and NAPBC accreditation, annual Screening Log build, Iron Mountain inventory & boxing of study master files for off-site file storage, FLORENCE platform DOA builds).
• Maintain meeting minutes for departmental monthly meetings.
• Standardize Work Instructions for various departmental tasks.
• Re-organizes and standardizes the department’s Shared Drive folder structure.
• Supports Manager in Process Improvement projects and root cause analysis for deviation reporting.
• Supports Manager collaboration with the Marketing department.
• Analyzes our overall department’s data timeliness and study start-up timelines.

Requirements

• Education Requirements: Bachelor’s degree in a discipline related to the field assigned plus evidence of some academic course work and/or continuing education related to project coordination.
• Licensure/Certification Requirements: Professional Experience Requirements: Requires at least one (1) year of relevant experience. Previous clinical research experience preferred.

Skills

• Knowledge/Skills/and Abilities Requirements: Not specified in the job posting.