Social & Scientific Systems (S3), a division of DLH,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: Coordinate and conduct clinical research activities related to clinical research site identification, activation, enrollment / study implementation oversight, and closeout activities, including performance tracking and reporting. Candidate must be comfortable working in a 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 serving as the primary point of contact for assigned sites.
• Conduct site assessments, determine site needs, and develop and facilitate action plans to coordinate all activities that support site preparedness for protocol activation, implementation of the study, and closeout. This may include tracking and coordinating activities related to data management, pharmacy and IP management, regulatory and quality management, and specimen management and shipping.
• Draft and coordinate development of site resources such as standard operating procedures (SOPs), quality management plans, site/study management tools, Frequently Asked Questions, and informed consent documents.
• Track and report on site progress in real-time, working closely with site staff to resolve issues impacting progress and performance, and serving as a primary resource for sites needing information, advice, or other technical assistance.
• Maintain up-to-date records and documents in information management and reporting systems.
• Track and facilitate the regulatory document review process, including reviewing and filing documents to ensure compliance with regulatory requirements.
• Organize, schedule, and coordinate clinical research site staff training and educational efforts. Participate in development of training and educational materials and general training curricula suitable to specific study and site needs.
• Coordinate site assistance required for remedial or corrective action required as a result of performance evaluation, monitoring, or auditing.
• Conflict and Problem Resolution: Help to anticipate and identify potential problems and propose preventive measures and solutions. Assist in the identification and implementation of measures to facilitate process improvement.
• Contribute to review and revisions of draft protocols, Manuals of Procedures, and other supporting documents.
• Facilitate and manage meetings, conference calls, and training events. Track completion of project action items.
• Operations Management Support: Contribute to and lead aspects of cross-functional team coordination, collaboration, and task management. Provide procedural support and tracking related to site payments and contracts.
• Staff support: As assigned, provide mentoring, training, and oversight for other site support and administrative staff. As needed and appropriate, serve as a back-up for other administrative, management, and site support team members.
• Other duties as assigned.

Candidates for this position should have the following education/experience and demonstrate mastery of the following knowledge, skills, and abilities:

Education and Experience:

• A baccalaureate degree from an accredited college or university.
• Relevant experience or coursework in public health, biomedical research or other related field.
• A minimum of 5 years of increasingly responsible experience relevant to implementing clinical trials and supporting clinical trial sites.

Knowledge, Skills and Abilities:

• Strong oral and written communication skills.
• Proficiency in Microsoft XP, including Word, Excel, Outlook and PowerPoint, and experience working with databases.
• Work independently with minimal supervision but regular guidance from supervisor.
• Competently handle a heavy workload, and multiple projects with competing priorities, switching priorities quickly as needs change.
• Demonstrate a high level of technical skill and expertise as pertains to clinical research site support and development.
• Demonstrate high proficiency in project planning and organization and proactively anticipate and identify complex issues and problems to meet deadlines effectively.
• Draft documents and communications that are timely, accurate, and grammatically correct.
• Demonstrate exceptional interpersonal skills and written and verbal communication abilities.
• Recognize which decisions may have a consequential effect on the project, sponsor, and/or SSS and make decisions based on experience, skill, and situation, consulting with and/or informing others as appropriate.
• Preferred: Experience providing guidance, oversight, tracking, and issue resolution related to specimen collection, management, and shipping.
• Ability to travel up to 10%, if required in the future.

DLH is committed to fostering a diverse workforce and is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identify, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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