Title: Clinical Research Associate
Company: Social & Scientific Systems (SSS)
Location: Silver Spring, MD or Durham, NC
Social & Scientific Systems (SSS), a DLH company, works to improve public health worldwide by providing technical, research, and program management services to government, nonprofit, and commercial clients. The SSS team offers a synergy of expertise in clinical research services, epidemiology and public health studies, health data management and analysis, and program evaluation and policy analysis. Please join our dedicated staff in an environment that values diversity and supports health, well-being, and professional growth.
SSS, a DLH company, is seeking an In-House Clinical Research Associate who will be responsible for coordinating clinical research site participation in National Institutes of Health (NIH)-funded research through the management of administrative aspects of protocol development, site selection and preparation, and site implementation of clinical trials. Candidate must be comfortable working in a fast paced environment. Candidates based in our Silver Spring, MD or Durham, NC offices will be considered.
Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily:
- Site Liaison: Serve as the liaison between SSS and investigators and staff of clinical research sites regarding protocol implementation and site activation Track and report on site progress, work closely with site staff to resolve issues impacting site performance. Serve as a point of contact for sites needing information or other technical assistance.
- Site Assessment and Preparedness Evaluation: Coordinate all activities that support site preparedness for protocol activation, implementation, and May participate in visits to clinical research sites in order to assess the infrastructure, resources, and training needed to conduct clinical trials. In collaboration with the sponsor and other federal or contractual entities, develop plans and mechanisms for, and participate in, the evaluation of the sites’ preparedness to implement clinical trials. Work with the data management center to arrange training on data and laboratory systems if sites are unfamiliar with the applications. Work with the sites and client to ensure site laboratory capabilities. Prepare reports on findings and recommendations.
- Protocol Development and Implementation: Work with the client to set up call schedules, create call agendas, run calls, and provide call Coordinate activities associated with protocol development and implementation, including the dissemination and posting of final protocol documents, development of protocol-related documents including consent forms, clarification and information memos, manuals of operations, and other documents as needed.
- Regulatory: Track and facilitate the regulatory document review Review site informed consents, Form FDA 1572, site delegation logs, and other documents to ensure compliance with regulatory requirements. Document and archive site requirements for clinical trial implementation.
- Conflict and Problem Resolution: Anticipate and identify potential problems and propose preventive measures and Identify and implement measures to facilitate process improvement.
- Training Coordination: Organize, schedule, coordinate, conduct clinical research site staff training and education in areas such as: administration, site establishment, regulatory preparedness, site operations and record keeping, clinical research, and good clinical Coordinate logistics and participate in site training meetings and in site visits for the training of clinical research site staff. Develop training and educational materials suitable to specific study and site needs.
- Site Remedial Activities: Facilitate any needed site assistance required for remedial or corrective action required as a result of monitoring/auditing by the sponsor or other regulatory agencies or Participate as required in site assessment/site initiation visits.
- Coordination with the Client, Consultants, and Other Contractors and Regulatory Agencies: Lead conference calls and meetings, produce summaries, and track completion of project action Serve as a representative of the project and SSS, communicating professionally and effectively with the client and all collaborators.
- Additional duties as assigned.
SOCRA Exp: 8/13/2020