A Clinical Research Manager is responsible for managing the day-to-day research operations of an organization undertaking clinical trials, usually pharmacological drug testing.
Clinical Research Manager United Digestive - 3.2 Atlanta, GA Job Details Full-time 1 day ago Qualifications Staff supervision
HIPAA ICH
guidelines Bachelor's degree Project management experience in healthcare Managing clinical research teams Health information regulatory compliance Research regulatory compliance Clinical quality assurance standards General management Healthcare research Leading research teams FDA regulations Full Job Description
GENERAL SUMMARY OF DUTIES
Leads day-to-day multi-site clinical research operations, staff, and study execution from feasibility through closeout in alignment with the Director's strategy. Exceptional candidates with experience beyond the posted level are encouraged to apply. Based on qualifications, experience, and organizational needs, consideration may be given to placement at a higher level.
RESPONSIBILITIES
Duties include but are not limited to: Supervise and provide leadership to Clinical Research Coordinators and Research Assistants/Interns Lead day-to-day multi-site clinical research operations and promote consistent, efficient study execution Manage the study lifecycle from feasibility and startup through conduct, monitoring, and closeout Track enrollment, timelines, milestones, compliance, and data quality; resolve issues and escalate significant risks Serve as the operational liaison among investigators, sponsors, CROs, vendors, staff, and centralized support teams Ensure regulatory documentation and study activities meet FDA, ICH-GCP, HIPAA, IRB, sponsor, and organizational requirements Conduct quality reviews, implement SOPs and CAPAs, and maintain audit and inspection readiness Recruit, onboard, train, mentor, evaluate, and allocate research staff based on study and site priorities Support research systems, standardized workflows, and practical process improvements across sites
EDUCATION, SKILLS, & EXPERIENCE
:
Required:
Bachelor's degree in nursing, life sciences, public health, healthcare administration, or a related field At least five years of clinical research experience, including study coordination or site management and direct supervision of research personnel. Demonstrated experience managing study startup, site activation, conduct, monitoring, closeout, and multi-site operational workflows Knowledge of FDA regulations, ICH-GCP, HIPAA, and IRB requirements, with strong project management, people-leadership, communication, and organizational skills
Preferred:
Master's degree in clinical research, healthcare administration, public health, nursing, or a related field Clinical research certification and experience with research systems and process improvement
WORK ENVIRONMENT
Requires sitting and standing associated with a normal office environment. Travel required as business needs dictate.
DRUG FREE WORKPLACE
United Digestive is a drug-free workplace. All offers of employment are contingent upon passing a pre-employment drug screening.
EQUAL OPPORTUNITY EMPLOYER
United Digestive is an equal opportunity employer and will not tolerate discrimination in employment on the basis of race, color, age, sex, sexual orientation, gender identity or expression, religion, disability, ethnicity, national origin, marital status, veteran status, genetic information or any other legally protected classification or status. IND123
