We are hiring a Clinical Research Manager in Marietta GA. This is a full time, in person position.
Responsibilities Staff Management/Leadership
• Coordinate internal education for development of staff
• Evaluate employee performance using approved Performance Management model in
accordance with Human Resources Policy and Practice.
• Provide day to day oversight of research staff
• Provide appropriate levels of staffing and manage schedule of personnel
• Ensure appropriate orientation, education, credentialing, licensing, and continuing
professional development for personnel, including study-specific training, GCP training and
IATA certification
• Use behavioral interviewing techniques to hire and accept for transfer candidates to fill
vacancies in the department.
• Use independent judgment to reward exemplary performance and address substandard
performance in accordance with the employee disciplinary policy.
• Coordinate and monitor Trust survey completion and appropriate action planning sessions
and progress
Clinical and Translational Research Operations Oversight
• Provides operational oversight for clinical and translational research activities across multiple
research sites and therapeutic areas, ensuring consistent, high-quality execution of clinical
trials from start-up through close-out.
• Ensures research teams appropriately manage participant recruitment, screening, informed
consent, scheduling, and study visit conduct in accordance with approved protocols,
regulations, and institutional policies.
• Oversees implementation and adherence to protocol-required investigational procedures,
including clinical assessments, diagnostic studies, and investigational product accountability.
• Ensures effective data management practices are in place, including data accuracy, integrity,
and timely reporting, and serves as an escalation resource for resolution of complex data or
protocol issues.
• Provides oversight for specimen collection, handling, processing, and shipment activities to
ensure compliance with sponsor requirements, regulations, and chain-of-custody standards.
• Oversees study close-out activities, including documentation completeness, data
reconciliation, archiving, and regulatory reporting.
• Supports development of study budgets, monitors alignment with clinical trial billing
compliance requirements, and reviews financial reports to support investigators,
administration, and sponsors.
Research Operations Advancement and Process Improvement
• Partners with the Director of Research Operations to implement operational priorities,
enterprise initiatives, and process improvements to enhance research quality, efficiency, and
scalability.
• Contributes to the development, implementation, and standardization of research policies,
workflows, tools, and best practices across the research enterprise.
• Represents research operations in internal committees, sponsor interactions, and professional
forums, as appropriate.
• Builds and maintains collaborative relationships with investigators, clinical leaders, research
compliance, sponsors, and external partners to support research program growth and
innovation.
Training, Leadership, and Workforce Development**
• Provides leadership, guidance, and mentorship to research operations staff, supporting
performance management, professional development, and workforce engagement.
• Ensures consistent onboarding, training, and competency development of research staff,
including protocol-specific and general research procedures.
• Identifies knowledge gaps or operational challenges and collaborates with leadership to
support development of training resources and educational initiatives.
• Maintains current knowledge of clinical research regulations, best practices, and industry
trends and supports continuous learning within the research operations team.
Regulatory Compliance and Risk Management
• Provides leadership oversight to ensure compliance with federal regulations, institutional
policies, Good Clinical Practice (GCP), and sponsor requirements across all phases of clinical
research.
• Ensures research teams appropriately monitor, document, and report adverse events,
protocol deviations, and unanticipated problems in accordance with regulatory and
institutional requirements.
• Promotes human subject protection by ensuring standardized informed consent processes,
participant safety monitoring, and adherence to ethical research standards.
• Oversees preparation, maintenance, and quality review of essential regulatory documentation
for IRB submissions, sponsor reviews, audits, and inspections.
• Collaborates with investigators, research compliance, and leadership to identify compliance
risks and develop corrective and preventive action plans when issues are identified.
• Serves as an operational escalation point for complex regulatory, sponsor, or compliance
concerns.
• Collaborates with Manager, QA on quality assurance and regulatory matters.
Required Skills - 7 Years of Clinical Research Experience
- 2 Years in a Supervisor or Manager Role
- Must have BSN
Preferred Skills - Experience in Cardiology and Neurology
- Masters Degree
Schedule/Shift Monday-Friday 8am-5pm
