Research Specialist

Job Description

We are currently recruiting for a Research Specialist who will support project teams in the completion of both commercial and government clinical research projects. You will perform duties with minimal supervision by clinical research managers and project managers. You will be responsible for managing portions of projects under supervision of more experienced research staff. You will need to 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. Essential for the role is the ability to:

  • 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 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
  • Compile data, track, analyze and prepare reports including project status, project summaries, and recommendations. Lead data management activities. Work with clients and internal subject matter experts to develop database specifications. Document specifications and obtain approvals. Perform data management activity as needed
  • Develop and evaluate database specifications, write review and execute test scripts to verify systems meets specifications
  • 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
  • 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
  • Coordinate the activities of smaller, well-defined projects
  • Demonstrate a thorough understanding of company policies, procedures, and standards
  • May direct the work of less experienced staff and provide leadership and mentoring as appropriate
  • Ensure work is completed on time and is of the highest quality
  • Perform related duties as assigned

Desirable Skills and Experience

  • Three or more years of relevant experience. Previous experience within a pharmaceutical company, CRO, or within NIH is desirable
  • Familiarity with FDA and GCP regulations required
  • Knowledge of Microsoft Office tools including Word, Excel, and PowerPoint. Experience using data management systems preferred
  • Must be comfortable working in fast-paced environment and managing a heavy workload, and multiple projects with competing priorities, with the ability to switch priorities quickly as needs change
  • Exceptional interpersonal skills and written and verbal communication skills
  • Good decision-making and problem-solving skills
  • Strong organizational skills; accurate and detail-oriented
  • Demonstrated technical skill and expertise as it pertains to clinical research support

Rockville, MD, USA

Bachelor’s degree in science, health, or related field. Master’s degree preferred


Clinical Research

Full Time

23 Jul 2021