Sr. Clinical Research Coordinator

Overview

The Senior Clinical Research Coordinator provides comprehensive clinical research support across all phases of a study, including IRB submission, regulatory compliance, study start-up, implementation, and close-out. This role independently leads day-to-day study operations for principal investigators with limited supervision and manages complex activities related to the collection, documentation, analysis, and reporting of clinical research data. The Senior Clinical Research Coordinator applies advanced knowledge of Good Clinical Practice (GCP), Office for Human Research Protections (OHRP), and FDA regulations to ensure regulatory and ethical conduct of research.

This position may support multiple investigators across clinical and translational research projects and provides functional oversight and direction to Clinical Research Assistants and Clinical Research Coordinators as assigned.

Minimum Education – B.A./B.S. degree in a science, technical, health-related field or other applicable discipline with at least 3 years of relevant experience (Required) Or Master’s degree with at least 2 years of relevant experience (Required)

Minimum Work Experience – At least 3 years of experience with a bachelor’s degree (Required) Or at least 2 years of experience with a master’s degree (Required)

• Knowledge of clinical research designs and needed infrastructure.
• Familiarity with databases, data collection tools and data analysis methods.
• Ability to manage multiple complex activities while maintaining close attention to detail and not losing sight of the organizational mission.
• Interpersonal skills that demonstrate formal and informal leadership in a diverse professional environment.

• Internal candidates:
  Certification as a Clinical Research Professional (CCRP) through the Society of Clinical Research Associates (SoCRA) or equivalent research certification. Upon Hire (Required)
• External candidates:
  Certification as a Clinical Research Professional (CCRP) through SoCRA or equivalent research certification within one year of hire. 1 Year (Required)

• Responsible Conduct of Research
  • Consistently demonstrates adherence to the standards for the responsible conduct of research.
  • Plans, conducts and manages research projects within federal and institutional regulations and policies under the direction of the principal investigator.
  • Stays informed of and adheres to institutional policies, and federal regulations (e.g. Titles 21 and 45 of the Code of Federal Regulations) and guidances (International Counsel on Harmonization) regarding human subjects’ research and use of protected health information.
  • Uses research funds and resources appropriately.
  • Maintains confidentiality of data as required.
  • Meets all annual job-related training and compliance requirements.
• Research Administration
  • Maintains knowledge and comprehension of assigned research protocols, including study procedures, timelines and eligibility.
  • Accurately creates, completes, maintains, organizes and accounts for study materials, including participant lists and visit logs, regulatory binders, case report forms, laboratory kits, investigational product(s) and participation incentives.
  • Uses and accounts for research funds and resources at performance level, including reconciling research subject billing if assigned.
  • Attends study meetings, which could include overnight travel, as requested by principal investigator.
  • Works well with other members of the research team, appreciates a diverse workplace and seeks and provides input when appropriate.
  • Serves as an effective liaison between the investigators, sponsors, hospital departments involved with research studies and the Clinical Research Center.
  • Identifies and resolves issues and challenges with appropriate input and oversight.
  • Reviews journals, abstracts and scientific literature to obtain information relevant to clinical research programs.
  • Creates standard operating procedures (SOPs), and implements operational plans.
  • Provides oversight and training to study team members for a variety of…