Director Clinical Research

Children's Healthcare of Atlanta • Brookhaven, GA

4d • Onsite

About The Position

Works with the vice president of research and academic administration and chief academic officer to develop, lead, and manage clinical research occurring within Children’s and via Children’s collaborative relationships. This role helps support and fosters a growing research environment, ensures compliance with regulatory agencies and alignment with Children’s overall mission and strategic plan.

Requirements

• Minimum ten years’ experience in health care, with five years’ experience in a leadership role focused on clinical research
• Bachelor’s degree business, health care administration, or related health care field required
• Demonstrated excellent communication, organizational, and interpersonal skills, as well as aptitude for conflict resolution, negotiation, problem solving, and financial acumen
• Demonstrated experience with staff development building cross functional teams and creating a shared team objective, focus, and performance
• Demonstrated ability to develop strong working relationships with all constituencies in a short time frame
• Working knowledge of research federal, state, and local regulations, the NIH, FDA, and other potential sponsors
• Demonstrated fiscal responsibility and ability to create and manage multiple operational and funded research budgets including feasibility reviews of proposed studies
• Strong background in clinical research operations, developing and implementing tools for process improvement, and ability to create ad hoc reports to manage studies
• Active participation on system-level committees, such as research and academic guiding teams, Pediatric Institute Operational guiding team
• Demonstrated expertise and knowledge of hospital-based accreditation needs for qualifying clinical areas (PRU, IDS, Lab); particularly JCAHO and CMS

Nice To Haves

• MHA, MPH, or MBA
• BSN, RN
• CRA, CHRC, CIP and/or CCRP certification
• Demonstrated understanding of clinical research process and operations in both the inpatient and outpatient clinical settings.
• Demonstrated experience in administration and provision of regulatory oversight of funded research including NIH, private, and industry sponsored research

Responsibilities

• Provides oversight and direction for Children’s Clinical Research activities, including business planning, and staff development.
• Directs and oversees all clinical research and processes for appropriateness and alignment with mission and business plan.
• Develops, implements, and evaluates clinical research programs to promote the recruitment, retention, professional development, and continuing education of all research staff in the system.
• In partnership with vice president for research and academic administration, chief research officer, develops system-wide, long-term strategy for research.
• Serves as liaison for clinical research between the Research Office and the Service Line leaders at Children’s, division leaders in the Emory DoP and Research Administration, administrative and scientific/research leadership at academic partners including but not limited to Emory, Ga Tech, and Morehouse.
• Directs and provides resources to mentor investigators and research staff in the development of research programs, projects, and proposals, and throughout the process.
• Develops and manages comprehensive education plans for physicians, allied health providers, and other Children’s staff related to clinical research activities.
• Develops the process and resources to assist investigators in the writing of study protocols for grant and/or contract applications including feasibility review and appropriate budgets.
• Develops the process and resources to assist investigators in the development of INDs/IDEs for study purposes including creation of regulatory binders and other required documentation.
• Provides oversight and fiscal management and participates in routine reporting for clinical research.
• Demonstrates fiscal responsibility in operating budget preparation, analysis, and management.
• Provides support for the grant and contract application process for all program specific grants/contracts and clinical trials in collaboration with appropriate personnel and ancillary departments.
• Maintains program specific databases for routine reporting, financial and goal performance.
• Reviews and resolves monthly departmental financials.
• Develops routine reports for presentation at Board level meetings.
• Meets with area of service contacts and financial coordinators periodically to audit patient billing to ensure research procedures have not been billed inappropriately.
• Participates as member of Research Leadership team through participation in Research Operations Committee, Pediatric Technology Center, Research Advisory Council, and Georgia CTSA, in partnership with Emory and Georgia Tech.
• Leads in the development of relationships and grant opportunities with community and academic institutions, such as TCCN, Children’s professional staff members in private practice, University of Georgia, Mercer, and others.
• Serves as a co-leader in Pediatric Institute strategy, process improvement and quality improvement initiatives (PI Workgroup, etc.).
• Oversees and manages research affiliated ancillary departments, including Pediatric Research Unit, Research Processing Lab, and Investigational Drug Services.
• Partners with home ancillary divisions to maintain all certifications, licensures, and accreditations according to federal and state mandates.
• Provides direct oversight of Children’s Pediatric Research Unit, including personnel, fiscal, and operational management.
• Maintains continued JCAHO accreditation of PRU and all hospital-based billing research entity.

What This Job Offers

• Job Type: Full-time
• Career Level: Director