Clinical Research Quality & Operations Manager

Benefits

Qualifications

• •Proven experience in supervising teams within a clinical or scientific research setting
• •Strong understanding of clinical research methodologies and practices, including experience with clinical trials
• •Familiarity with data collection techniques and laboratory procedures relevant to clinical studies
• •Demonstrated leadership skills with the ability to motivate and guide team members effectively
• •Knowledge of Good Clinical Practice (GCP) regulations and compliance management practices
• •Excellent project management skills, with the ability to prioritize tasks effectively in a fast-paced environment
• •Strong analytical skills with attention to detail in data management and reporting
• •Clinical research: 1 year (Required)
• •West Palm Beach, FL 33407 (Required)
• •6 more items(s)

Responsibilities

• •This a pivotal role responsible for ensuring the highest standards of quality, regulatory compliance, and operational efficiency across all clinical trials, while also
• •playing a key role in business development, team leadership, and patient safety
• •The manager is a proactive and organized professional with extensive clinical research experience, strong leadership skills, and the ability to manage complex situations in a dynamic environment, including inpatient psychiatric trials
• •Conduct daily quality control of visit documentation across all active studies
• •Ensure adherence to study visit schedules and protocol requirements
• •Maintain an audit-ready environment through regular internal quality audits and corrective/preventive action plans (CAPAs)
• •Oversee timely and complete reporting of Adverse Events (AEs) and Serious Adverse Events (SAEs) per protocol, sponsor, and regulatory requirements
• •Ensure accurate and timely maintenance of all regulatory binders, including IRB communications, 1572s, CVs/licenses, and training records
• •Maintain version control and site-wide awareness of all protocol and informed consent changes
• •Operational Leadership & Oversight
• •Work with the leadership team to develop and implement strategic improvement plans for operational efficiency, compliance, and patient care
• •Assist in day-to-day oversight of clinical operations, including Clinical Research Coordinators (CRCs), Investigators, and the Recruitment team
• •Ensure CRCs complete medical record requests and follow through on outstanding documentation
• •Run and manage operational reporting
• •Maintain ongoing communication with CROs and Sponsors to ensure alignment and resolve queries efficiently
• •Lead efforts in staff training, protocol compliance, and issue resolution
• •Clinical Coverage & Backup
• •In the absence of the CRC, take full responsibility for coordinating and executing clinical trial activities, including patient visits, data collection, documentation, and sponsor communication
• •Support During Inpatient Trials & Crisis Management
• •Provide support during complex psychiatric inpatient trials, including patient de-escalation and team coordination
• •Manage staff morale and engagement and intervene in high-stress or emotionally charged situations as needed
• •Provide off-hours phone support and crisis coverage during inpatient studies, including evenings and weekends
• •Availability for flexible scheduling, including Monday through Friday, with some weekend support as needed
• •Other tasks assigned as needed
• •21 more items(s)