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
*We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state, and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance (FCIHO), Los Angeles Fair Chance Ordinance for Employers (ULAC), The San Francisco Fair Chance Ordinance (FCO), and the California Fair Chance Act (CFCA).
*As a job position within our Clinical Sciences division, a successful completion of a background check may be required as a condition of employment. This requirement is directly related to essential job functions including but not limited to: high-risk working environments (laboratories, clinical settings), handling hazards chemicals or lab specimens, conducting direct patient care, accessing medical and confidential records, access to prescription medication or other drugs, and job duties that can cause serious injury or death as a result of error. Due to these job duties, this position has a significant impact on the business operations and reputation, as well as the safety and well-being of individuals who may be cared for as part of the job position or who may interact with staff or clients.