Clinical Research Manager - Trauma & Acute Care Surgery
Apply NowCompany: Carolinas HealthCare System
Location: Charlotte, NC 28269
Description:
Job Description
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
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.
About Us
Atrium Health is one of the nation's leading healthcare organizations, connecting patients with on-demand care, world-class specialists and the region's largest primary care network. A recognized leader in healthcare delivery, quality and innovation, our foundation rests on providing clinically excellent and compassionate care.
We've been serving our community since 1940, when we opened our doors as Charlotte Memorial Hospital. Since then, our network has grown to include more than 40 hospitals and 900 care locations ranging from doctors' offices to behavioral health centers to nursing homes.
Our focus: Delivering the highest quality patient care, supporting medical research and education, and joining with partners outside our walls to keep our community healthy.
About the Team
Our Mission Statement, Vision and Values
Our Mission: To improve health, elevate hope and advance healing - for all.
Our Vision: To be the first and best choice for care.
Our Values: We recognize that employees are our most valuable asset. We have identified four core values we hold in the highest regard: caring, commitment, integrity and teamwork.
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.
About Us
Atrium Health is one of the nation's leading healthcare organizations, connecting patients with on-demand care, world-class specialists and the region's largest primary care network. A recognized leader in healthcare delivery, quality and innovation, our foundation rests on providing clinically excellent and compassionate care.
We've been serving our community since 1940, when we opened our doors as Charlotte Memorial Hospital. Since then, our network has grown to include more than 40 hospitals and 900 care locations ranging from doctors' offices to behavioral health centers to nursing homes.
Our focus: Delivering the highest quality patient care, supporting medical research and education, and joining with partners outside our walls to keep our community healthy.
About the Team
Our Mission Statement, Vision and Values
Our Mission: To improve health, elevate hope and advance healing - for all.
Our Vision: To be the first and best choice for care.
Our Values: We recognize that employees are our most valuable asset. We have identified four core values we hold in the highest regard: caring, commitment, integrity and teamwork.