Research Specialist I

MPF Federal is seeking a Research Specialist to support project teams in completion of commercial and government clinical research projects. Perform duties with supervision by clinical research managers and project managers. May manage portions of projects under supervision of more experienced research staff. Create, review, and maintain project documentation according to project requirements. Coordinate clinical trial start-up activities and on-going active trial requirements. Investigate problems and resolve or recommend solutions. Coordinate with clients, sponsors, and site personnel to ensure project needs are met. COMPENSATION: $55,000.00 - $65,000.00 Annually This position is remote; however, the person should reside in the Bethesda, MD area.

Demonstrate a thorough understanding of the application of basic clinical research methodologies to meet protocol and regulatory requirements. Develop client materials according to project requirements, including but not limited to, project-specific documentation, operating procedures, standards, and work flows. Monitor project changes to ensure documentation and systems/software conforms to new requirements. Process incoming and outgoing project materials to monitor, verify, and track receipt of documentation and ensures appropriate distribution of materials to internal and external research personnel and sites. Execute assigned portions of clinical studies. Carry out activities while optimizing efficiency, quality and consistency, while maintaining compliance with SOPs, policies and procedures. Coordinate the activities of smaller, well-defined projects. Communicate with clients, sponsors, and site personnel to ensure project needs are met. Compile data, track, analyze and prepare reports including project status, project summaries, and recommendations. Support data management activities. Work with clients and internal subject matter experts to develop database specifications. Document specifications and obtain approvals. Perform data management activities as needed. Prepare general correspondence, agendas and meeting minutes, reports, and other project-specific documentation. Ensure review, approval, and distribution to internal staff and external project participants. Provide logistical support for committee meetings and DSMB meetings, including planning, arrangements, travel and post-meeting activities and writing reports. Design build, and update spreadsheets and other tracking tools. Recognize which decisions may have a consequential effect on the Project and make decisions based on experience, skill, and situation, consulting with and/or informing others as appropriate. Maintain clinical research files and related documents. Demonstrate a thorough understanding of company policies, procedures, and standards. Ensure work is completed on time and is of the highest quality. Perform related duties as assigned.