Site Team Leader

All Jobs  >  Site Team Leader Apply Site Team Leader Fully Remote • REMOTE WORKER Apply Description   SUMMARY: The Site Team Leader (STL)plays a critical role in ensuring clinical trial sites operate efficiently, meet timelines, budget, and quality expectations through remote oversight of clinical sites. Working closely with Regional Site Directors and other Research Operations leaders, this individual will ensure the execution of clinical trial activities in compliance with all applicable regulations. This role will provide close and continued communication with site employees, provide training and mentoring to enhance performance and adherence to best practices. The STL will also ensure engagement of the team.This role requires close collaboration with cross-functional teams, including site-level leadership, to drive successful clinical trial execution, develop site staff, and position sites for study awards. Responsibilities include site onboarding, maintaining site research readiness, coaching site staff, reviewing site metrics for decision-making, compiling and leading monthly business reviews, and ensuring quality oversight. Key development areas include Adverse Event reporting, Motivational Interviewing, regulatory and compliance updates, and operational changes related to program quality monitoring. By leveraging their expertise in site operations, this individual will craft and execute a strategic approach that enhances site performance, drives business outcomes, and supports the success of Site Operations across their region. Requirements Essential Duties: Study Start-Up and Planning:· Collaborating with study teams and PMs to develop study plans for successful implementation of newly awarded trials. Ensuring adherence to study startup plans in accordance with timelines.· Completing and/or confirming feasibility questionnaires, as necessary· Responsible for enrollment strategy to achieve and/or exceed enrollment objectives and working with patient engagement as needed for studies· Identifying potential risks and developing mitigation strategies. · Financial Management and resource allocation for the trial. Responsible for timely activation of clinical trials at sites and ensuring the site is prepared to successfully execute clinical trials. · Site-level Vendor managementSite Management and Oversight:· Manage overall operation of the sites including project plans and resources to ensure compliance with the protocol and contract.· Participation in preparation and support during all monitoring visits as needed · Tracking site enrollment and decision-making for enrollment enhancement· Managing quality issues and corrective actions· Ensuring site compliance with GCP guidelines and Good Documentation Practices.· Coaching, mentoring, and training site staff. to ensure efficient and high-quality site operations· Maintain an overview of clinical trial operational status or risks and proactively communicate the progress, issues, or protocol revisions that may impact timelines and costs.· Assists with an understanding of protocols and study procedures.Team Leadership and Communication:· Leading site-level staff and managing performance· Collaborate effectively and interact professionally with team, patients, and study staff (including sponsor/CRO). · Developing customer relationships with site CRAs and other sponsor/CRO staff· Support business development and operations to achieve study awards· Providing regular updates on trial progress to stakeholders and compiling metrics.· Responsible for site business reviews at an established cadenceCompliance and Regulatory Oversight:· Ensuring adherence to all applicable regulatory requirements (ICH-GCP). · Preparing for sponsor/CRO and/or regulatory audits. · Act as a liaison to the Investigator(s) to ensure appropriate investigator oversight is maintained.· Perform periodic quality reviews of the investigator...