Research Specialist - KAI Research

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Category: Experienced (non-manager)
Location: Rockville, Maryland
Job Type:
Full Time
Education: BS or MS

Job Description:

  • 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.

Preferred Skills:

  • Well versed in all Microsoft Office products including Word, Excel and Powerpoint
  • Demonstrate time management skills by completing tasks on time and of high quality with little supervision
  • Execute assigned portions of clinical studies while optimizing efficiency, quality and consistency, while maintaining compliance standard procedures.
  • Demonstrate a clear understanding of clinical research practices and procedures
  • Prepare high quality and accurate project-specific documentation (agendas, minutes, reports etc.)

If you would like to apply for this position, or would like a discussion about this, or any other role, please send your contact details, together with your curriculum vitae to:

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