Clinical Research Manager - Trauma & Acute Care Surgery

Overview

Job Summary

Assesses, plans, coordinates, and evaluates the operational functions of clinical research. Manages the various studies and ensures compliance with regulatory agencies.

Essential Functions
 

• Coordinates and facilitates day to day operations associated with research projects and compliance.
• Manages subjects via recruitment, informed consent, protocol assessments, and data collection.
• Initiates and maintains relations for study protocols. Interviews and trains new research staff.
• Reviews, maintains, and archives study administrative and data management files. Manages sponsored projects.
• Assists in monitoring compliance and communication.
• Plans for future trends in clinical research.
• Works with Clinical Research Director to plan for future trends in clinical research.
• Manages a team of 8-9 Sr Research Associates and Research Coordinators that provide 24/7 coverage for Trauma ACS research.
• Ensures audit-readiness of all projects.
• Facilitates efficiency across project from startup to closeout.
• Participates in protocol development of investigator-initiated studies.

Physical Requirements
 

Works in both inpatient and outpatient clinical care areas. May be required to travel to local area hospitals and physician offices. Works in office environment. Requires walking, sitting, operation of keyboard and computer. Responsible to work in a safe manner.

Education, Experience and Certifications
 

Bachelor's of Science Degree required; Master's Degree in Business or Health Care Administration preferred. Previous research experience preferred. Knowledge of Good Clinical Practices (GCP) and International Conference on Harmonization (ICH) Guidelines, basic scientific methods, biological principles, medical terminology, and regulatory requirements of the FDA and IRB preferred.

Preferred:  Experience working in inpatient setting, conflict resolution and team building techniques as well as experience with FDA audits, sponsors etc.