Manager- Clinical Research Operations

Northside Hospital Inc.; Atlanta (GA); On-site; USD 90,000 - 120,000; Full time

Job summary

Northside Hospital Inc. is seeking a Research Program Manager in Atlanta to oversee clinical research projects, ensure regulatory compliance and drive cross-department collaboration across hospital divisions.

The role requires strong project management, GCP knowledge and the ability to lead teams while interfacing with CROs, sponsors and monitors. This position supports quality, training and SOP development within NSH's research program.

Qualifications

• Bachelor's degree in a relevant field; MBA preferred.
• Minimum of 5 years’ experience in a clinical research setting.
• Ability to interpret laws, regulations and policies related to research compliance.
• Strong organizational and project management abilities with multitasking.
• Knowledge of clinical trial policies and Good Clinical Practice (GCP).
• Interpersonal skills with motivation and ability to work independently.
• Demonstrated analytical and problem-solving abilities.
• Ability to work both independently and as part of a team.
• Experience managing teams of varying sizes.
• Familiarity with IT systems supporting regulatory affairs, IRB and compliance.

Responsibilities

• Manage research projects assigned by the Research Program Director.
• Manage assigned departments/staff.
• Support Research Program with goals, metrics and documentation of activities.
• Identify collaborations across project teams, practices and hospital departments.
• Coordinate and lead meetings with NSH departments on new project feasibility.
• Ensure quality and integrity of research.
• Serve as point of contact for CROs/SMOs/sponsors for monitor visits, coordinating with CRCs/CRNs.
• Monitor all research activity and stay aware of ongoing clinical projects.
• Provide compliance oversight for day-to-day operations.
• Develop, maintain and evaluate SOPs for administering clinical research.
• Conduct training on GCP, FDA, NIH and human subject protections.

Skills

Project management

Regulatory compliance

GCP & FDA familiarity

Analytical thinking

Interpersonal skills

Independent work

Team leadership

Education

Bachelor's degree in a relevant field

MBA preferred

Job description

Overview

Northside Hospital is award-winning, state-of-the-art, and continually growing. Constantly expanding the quality and reach of our care to our patients and communities creates even more opportunity for the best healthcare professionals in Atlanta and beyond. Discover all the possibilities of a career at Northside today.

Responsibilities

PRIMARY DUTIES AND RESPONSIBILITIES

• Manage research projects assigned by the Research Program Director


• Manage assigned departments/staff


• Support Research Program with the development of appropriate goals, metrics and required documentation of project activities.


• Identify collaborative opportunities across project teams, practices, and hospital departments.


• Coordinate and lead meetings with NSH departments analyzing the feasibility of new research projects.


• Ensure the quality and integrity of research.


• Serve as a point of contact for Monitor visits from CROs, SMOs, and sponsors to help coordinate the visits with CRCs and CRNs and the availability of all necessary information to ensure accuracy and compliance.


• Monitors all research activity and maintains awareness of all clinical research projects.


• Provides compliance oversight for day-to-day operations


• Develops, maintains, and evaluates the SOPs for administering clinical research


• Conducts training on GCP, FDA, NIH, Human Subject Protection and necessary regulations.

ADDITIONAL DUTIES AND RESPONSIBILITIES

• Resolve research conflicts during the normal course of business


• Maintain professional knowledge and skills, particularly in the areas of Good Clinical Practice guidelines and other research regulations


• Participate in the review, development and maintenance of automated processes and information technology for clinical research related activities


• Develop, maintain, and deliver education and training programs for the NSH research community, protection of human subjects, the research life cycle, protocol development, monitoring visits, and others.


• Other duties as assigned

Qualifications

KNOWLEDGE SKILLS AND ABILITIES/LICENSE OR CERTIFICATION REQUIRED

• Bachelor\'s degree in a relevant field. MBA preferred.


• Minimum of 5 years’ experience in a clinical research setting


• Ability to correctly interpret laws, regulations and policies related to research compliance


• Excellent organizational and project management skills with the ability to manage multiple tasks simultaneously


• Knowledge of clinical trial policies and regulations and Good Clinical Practice (GCP)


• Established interpersonal skills combined with the ability to be highly motivated and work independently


• Demonstrated analytical and problem solving skills


• Ability to work independently and as part of a team


• Ability to manage teams of varying sizes


• Knowledge of information technology systems supporting regulatory affairs, IRB and compliance research administration

Work Hours

8-5p