POSITION OBJECTIVE
Working with a high degree of independence and under general direction of the laboratory manager, coordinate major activities in research and diagnostic related technical areas. The Research Assistant 4 will assist in coordination of major activities for the chemistry subdiscipline, using a variety of analytic platforms for diagnostic testing and research efforts at the National Prion Disease Pathology Surveillance Center. In addition, cross train and acquire proficiency in other protein-based testing, including molecular testing for research and diagnostics.
ESSENTIAL FUNCTIONS
Provide input and recommendation to principal investigator and laboratory director regarding significant developments in research projects, new test validation for diagnostic, and surveillance monitoring. Coordinate all major diagnostic testing activities and research in the lab. This includes maintaining schedules, ensuring compliance with protocol guidelines and requirements of regulatory agencies; identifying problems and/or inconsistencies and monitor study participants’ progress to include documentation and reporting of adverse events; recommend corrective action as appropriate. Prepare IRB updates. Represent the lab and serve as a liaison between study sponsors, clinical research organizations, and study monitors providing direction on a variety of issues. Plan and manage site visits including accurate chart information, adverse event reports, information for data queries, and information for internal and/or external audits as required for each study and each study participant. Coordinating data collection and surveillance efforts; organizing all program meetings. (30%) Coordinate major activities of laboratory/ research. Provide input and recommendations to the laboratory director and laboratory manager regarding significant developments in diagnostic and surveillance projects. Provide input and recommendations about ongoing diagnostic assays, validations, and works with laboratory leadership to identify growth in the diagnostic and surveillance areas for prion disease and other adult neurodegenerative disorders. Assist in preparing for regulatory inspections from Ohio State and New York State. Coordinate information with others as needed (20%) Perform the high complexity analytical procedures. Utilize new and innovative research techniques involving a high degree of skill and training. (20%) Assist in developing procedures; coordinate information with others as needed. Coordinate major activities of laboratory/ research like standard of procedures for diagnostic testing, competency of testing personnel in the molecular laboratory. (10%) May teach or instruct others in research techniques. Train assigned stakeholders on human subjects’ research and ensure all proper institutional Training / documentation has been received prior to initiation of work on designated protocols. Teach postdoctoral scholars/fellows and trainees bio banking / biorepository best practices. Provide analytical and pre-analytical training and oversight to laboratory staff. (10%)
NONESSENTIAL FUNCTIONS
Co-author diagnostic, surveillance, and research projects. May participate in manuscript and grant writing, co-author test validation or research projects and independently write progress reports, manuscripts and tasks related to clinical trials (5%) May assist research assistants, technicians, and part-time students. Support clinical and research staff, including research associates or testing personnel, students, fellows and residents and lower-level research staff, assure, all guidelines are followed by the project staff for each study. (5%) Perform other duties as assigned. (<1%)
CONTACTS
Department: Daily contact with NPDPSC leadership, technical staff, and administrative staff to discuss diagnostic testing and research and maintain workflow in the laboratory.
University: Occasional contact with other departments to share information.
External: Some contact with vendors to exchange information.
Students: Limited or no contact with student employees to exchange information.
SUPERVISORY RESPONSIBILITY
May supervise research assistants and technicians. Train new laboratory technicians and student employees and occasionally direct the work of student employees when necessary.
REQUIREMENTS
Experience: 5 to 8 years of related experience required.
Education/Licensing: Bachelor’s degree in science. ASCP certification or other clinical specialty like chemistry C(ASCP) or medical technologists (MLS or MLT) is preferred.
REQUIRED SKILLS
Must be extremely well organized and capable of setting priorities while maintaining consistent attention to accuracy and quality. Must show great transparency in work and be able to create SOP’s as necessary for work functions and protocols. Must keep exceptionally accurate and easily retrievable records. Has knowledge of commonly-used concepts, practices, and procedures within the field of prion diseases. Must be motivated to explore and learn new laboratory techniques and must be able to teach laboratory techniques to other technicians. Ability to work under pressure, multi-task, and be a team player. Punctuality and good attendance required. Ability to meet consistent attendance. Must be able to manage specimen storage. Ability to operate a variety of laboratory equipment. Excellent oral and written communication skills and interpersonal skills; must demonstrate the ability to effectively and professionally communicate and work with various individuals from a broad spectrum of disciplines, technical and educational backgrounds within the department, School and University, and with individuals outside the university. Good/strong organization skills; ability to multi-task, prioritize and meet deadlines. Must demonstrate attention to detail and accuracy, time management skills, and follow-through. Ability to work with sensitive information and maintain confidentiality. Effective problem-solving skills; must demonstrate sound judgment and good decision-making. Must demonstrate compliance with university policies and procedures guidelines and other applicable regulatory guidelines (CLIA, NY State CLEP). Ability to interact with colleagues, supervisors and customers face to face.
WORKING CONDITIONS
Standard laboratory conditions with some hazardous chemicals. Special hazards include biohazardous (potentially infectious) human brain and cerebrospinal fluid and other bloodborne pathogens and chemicals. The following personal protective equipment required: appropriate gloves, protective eyewear, laboratory coat, and safety shoes.
This position does not qualify for the Case Western Reserve University hybrid work program.
