SSS, a DLH Corporation company, serves federal government clients throughout the United States and abroad delivering technology enabled solutions in key health and human services programs. The Company's core competencies include secure data analytics and statistics, clinical trials and laboratory services, a full suite of public health research offerings, performance evaluation, system modernization, operational logistics and readiness, and strategic digital communications. DLH has over 2,000 employees serving numerous government agencies. DLH’s portfolio consists of Defense & Veteran Health Solutions, Human Services Solutions and Public Health & Life Sciences. FUNCTION: Manage a range of clinical trial operations and staff activities including site identification and activation, site management, policy and procedure development, protocol team support, training and mentoring, and management of timelines and deliverables. Candidate must be comfortable working in a very fast-paced environment. Key duties and responsibilities may include, but are not limited to, the following: - Manage and participate in all site identification and management activities including project planning, developing processes and tools, and overseeing, training, and mentoring staff in the conduct of the following activities:
- Conducting site assessments, determining site needs, and developing and facilitating action plans to coordinate all activities that support site preparedness for protocol activation, implementation, and closeout.
- Drafting and coordinating development of site resources such as standard operating procedures (SOPs), quality management plans, site/study management tools, Frequently Asked Questions, and informed consent documents.
- Providing guidance, oversight, tracking, and issue resolution related to specimen collection, management, and shipping.
- Tracking and reporting on site progress, working closely with site staff to resolve issues impacting site performance, and serving as a point of contact for sites needing information, advice, or other technical assistance.
- Tracking and facilitating the regulatory document review process, including reviewing and filing documents to ensure compliance with regulatory requirements.
- Organizing, scheduling and coordinating clinical research site staff training and educational efforts. Participating in development of training and educational materials and general training curricula suitable to specific study and site needs.
- Coordinating site assistance required for remedial or corrective action required as a result of performance evaluation, monitoring, or auditing.
- Participate in interviewing, hiring, oversight, mentoring, and evaluation of staff.
- Contribute to planning and operational management of information management and reporting systems.
- Draft and coordinate revisions to policies, procedures, and guidance documents. Coordinate development and revisions to Manuals of Procedures (MOPs). Assist in review of protocol drafts, and ensure consistency across supporting documents. Coordinate with all relevant parties to solicit contributions and revisions, gain necessary consensus and approvals, and provide necessary follow-up training and education.
- Facilitate and manage project meetings, conference calls, and training events. Track completion of project action items.
- Conflict and problem resolution: Anticipate and identify potential problems and propose preventive measures and solutions. Identify and implement measures to facilitate process improvement.
- Coordination with clinical trial sponsors, consultants, and other contractors and regulatory agencies. Serve as a representative of the project and SSS, communicating professionally and effectively with the client and all collaborators.
- Project management: Oversee aspects of project activities, contribute to project planning, review budgets and draft budget justifications, assist with payments and contracts tracking, manage vendors, and contribute to client deliverables through activities such as maintaining project timeline, providing client operations updates, and contributing to monthly client progress reports.
- Additional duties as assigned.
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