Research Manager - Levine Children's Hospital - Vaccine Trials

Overview

Essential Functions of the Vaccine Research Manager: 

• Responsible for the onsite management and oversight of the day-to-day patient care research component of the Clinical Protocol and Data Management research teammates within the Atrium Health Levine Children’s Hospital Research Network, reporting directly to the Pediatric Research Director
• Plans, directs, coordinates, and evaluates the clinical management of research protocols and clinical research care systems.
• Supervises the activities of research nurses, research coordinators, lab personnel, research associates
• Coordinates, plans, and develops training programs for clinical research personnel on research protocols
• Develops, communicates, and administers clinical research policies and procedures to clinical research personnel in accordance with federal, institutional, and departmental policies and procedures.
• Ensures appropriate protocol assignments to research staff based on length of experience, complexity of protocol, number of active patients, data requirements, reporting methods, and programmatic needs.
• Maintains open communication with physicians and research staff to ensure appropriate level of support for all research related activities.
• Develops strategies to promote enrollment of diverse patient populations and ensures regulatory compliance in accordance with local, state, and federal regulations.
• Ensures timely sponsor submission, IRB submissions, and regulatory filings by PIs and study teams, and adhere to reporting requirements to the IRB, institutional department, sponsor, and local/federal agencies.
• Partner with division Pre and Post Award Coordinators to monitor monthly financial reports, evaluate budget variances, and develop recommendations to facilitate meeting budget requirements.

Additional Training and Certifications 

• Five years' research experience, three years of which must have been in clinical trials and one year of which must have been at the administrative and/or supervisory level
• Experience working with children preferred
• Certified Research Professional via SoCRA/ACRP preferred.
• Must complete the CITI certification for Human Subject Research and GCP training if not already completed

Atrium Health Levine Children’s Hospital (LCH) has taken the community to another level of service in order to provide care for the growing population of children in our region.  At 247 beds, LCH is the largest children’s hospital between Atlanta and Washington DC.  It serves high patient acuity as the flagship children’s hospital within the innovative Atrium Health and offers a full complement of over 125 pediatric subspecialists in over 25 different pediatric specialties.  There are 4 pediatric hospitalist teams, a 20-bed PICU (including Cardiac ICU), an 85-bed NICU, and an inpatient pediatric rehabilitation facility.  Levine Children’s also has the region’s first 24/7 emergency room just for kids, staffed by doctors trained in pediatric emergency medicine.  LCH has repeatedly been ranked among the “Best Children’s Hospitals” in the nation by US News & World Report.

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; analysis, financials, outcomes.
• 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.
   

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 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.