Senior Clinical Trials Lead & Study Operations

Socket.dev; Lewisville (TX); On-site; USD 70,000 - 100,000; Full time

Job summary

Alliance Clinical Network is seeking a Senior Clinical Research Coordinator to plan and manage study projects, ensuring compliance with protocols and regulatory requirements, while coordinating activities, data collection, reporting and documentation to maintain integrity and efficiency of research operations.

You will provide leadership to clinical staff, resolve site-level issues, oversee data quality and collaborate with CRO/CRA and IRB to keep enrollment, timelines and quality on target.

Qualifications

• Associate’s degree or healthcare certification completed.
• Ability to lead and coach a team.
• Strong leadership and communication skills.
• 2+ years in clinical research.
• FDA, GCP knowledge; confidentiality.

Responsibilities

• Provide work directions to clinical staff and back-office team.
• Provide operational leadership to resolve complex study issues affecting enrollment, compliance, and timelines.
• Review, comprehend, and communicate study protocols.
• Oversee SIV, PSV and IMV.
• Assist CRC team as needed to facilitate research and business needs.
• Conduct and manage clinical trials in accordance with SOPs.
• Oversee data quality and ensure accuracy and timelines of study data.
• Work closely with CRO/CRA and IRB.
• Manage start up documentation, training, and timelines.
• Communicate with sponsors to ensure customer satisfaction.
• Direct study resource planning and ensure allocation of supplies and equipment.
• Perform other duties as assigned.

Skills

Leadership

Communication

Time management

Detail orientation

Multi-tasking

Emotional intelligence

Education

Associate’s degree or healthcare certification

Job description

Alliance Clinical Network is seeking a Senior Clinical Research Coordinator to plan and manage study projects, ensuring compliance with protocols and regulatory requirements, while coordinating activities, data collection, reporting and documentation to maintain integrity and efficiency of research operations.

You will provide leadership to clinical staff, resolve site-level issues, oversee data quality and collaborate with CRO/CRA and IRB to keep enrollment, timelines and quality on target.