KAI Research, Inc. (KAI), a wholly owned Altarum Company. KAI is a full-service contract research organization (CRO) and health research company. Since 1986, we’ve helped pharmaceutical, academic, and federal clients bring innovative drug treatments and other interventions to market. We have supported several federal clients for multiple decades and coordinated hundreds of clinical trials and epidemiological studies in a wide variety of therapeutic areas.
KAI Research now seeks to hire a Research Specialist to join our team and support project teams in completion of commercial and government clinical research projects. You will perform duties with minimal supervision by clinical research managers and project managers. Manages portions of projects under supervision of more experienced research staff. Creates, reviews, and maintains project documentation according to project requirements. Coordinates clinical trial start-up activities and on-going active trial requirements. Investigates problems and resolves or recommends solutions. Coordinates with clients, sponsors, and site personnel to ensure project needs are met.
- Demonstrates a thorough understanding of the application of basic clinical research methodologies to meet protocol and regulatory requirements
- Develops client materials according to project requirements, including but not limited to, project-specific documentation, operating procedures, standards, and work flows. Monitors 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
- Executes assigned portions of clinical studies. Carries out activities while optimizing efficiency, quality and consistency, while maintaining compliance with SOPs, policies and procedures
- Compiles data, track, analyze and prepare repo rts including project status, project summaries, and recommendations. Lead data management activities. Work with clients and internal subject matter experts to develop database specifications. Documents specifications and obtain approvals. Performs data management activity as needed
- Develops and evaluates database specifications, write review and execute test scripts to verify systems meets specifications
- Prepares general correspondence, agendas and meeting minutes, reports, and other project-specific documentation. Ensures review, approval, and distribution to internal staff and external project participants
- Designs build, and update spreadsheets and other tracking tools
- Recognizes 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
- Maintains clinical research files and related documents
- Coordinates the activities of smaller, well-defined projects
- Demonstrates a thorough understanding of company policies, procedures, and standards
- May direct the work of less experienced staff and provide leadership and mentoring as appropriate
- Ensures work is completed on time and is of the highest quality
- Perform related duties as assigned
- Bachelor’s degree in science, health, or related field. Master’s degree preferred.
- Three or more years of relevant work 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 such as 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
ABOUT KAI RESEARCH:
- KAI Research's dynamic work environment emphasizes integrity, personal commitment, and teamwork. In addition to the meaningful and challenging work, KAI offers an outstanding benefits program that includes paid time off, tuition reimbursement, 401k (5% employer contribution), a flexible work environment, and much more. We invite you to explore exciting and rewarding career opportunities with us.
- KAI is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to, among other things, race, color, religion, sex, sexual orientation, gender identity, national origin, age, status as a protected veteran, or disability.
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