Working with a high degree of independence and under general direction, the Research Assistant 4 will coordinate major activities of the Cleveland Digestive Diseases Research Core Center (CDDRCC) in the clinical arena, as well as at the laboratory bench. The research assistant will develop and maintain a multi-institutional and multi-disciplinary blood, stool and tissue repository for principal investigators to conduct translational and patient-oriented research on inflammatory bowel disease. This position will develop and implement divisional best practices for CDDRCC biorepository and navigate users through the sample procurement process. The research assistant will be assigned additional protocols where a thorough knowledge of both clinical and basic science research is required, such as studies related to mesenchymal stem cells. In addition, this position will be responsible for extending the regulated research performed to additional community hospital sites to increase patient enrollment.
1. Manage the Cleveland Digestive Diseases Research Core Center biorepository by collecting, processing and storing human samples in accordance with published requirements and regulations, including divisional best practices. Administer the biorepository catalogue and ensure that samples may be retrieved and provided to customers in an efficient manner. Provide clinical and epidemiological data on specimens upon request, in accordance with regulatory guidelines. (20%)
2. Identify patients for the study according to protocol’s inclusion and exclusion criteria. Complete full medical chart review. Obtain informed consent from patients participating in the study. Educate study patients on investigator drug and study materials. Arrange follow-up visits, scheduling tests and procedures. Conduct study patients follow-up visits (review side effects, concomitant medication, overall health status, etc.). Maintain and dispense drugs and other study supplies. (20%)
3. Direct and manage overall integrity and organization of multiple projects and ensure that quality, safety and completion schedules are correct. (10%)
4. Coordinate major regulatory activities of assigned studies with central research staff and principal investigators. This includes, but shall not be limited to initial submission of regulatory protocols and creation of informed consent, annual review of assigned studies, IRB review/ approval of any amendments/ deviations and subsequent corrective action and on-site inspection of studies by IRB and/or sponsor. (10%)
5. Represent the Core Center 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. (5%)
6. Perform complex quantitative analytical procedures, such as validation of sample quality in relation to storage conditions and/or reagents introduced, or quality analysis of surgical specimens resected from surgical patients. (5%)
7. Review and make recommendations on procedural development for assigned studies. Provide expert advice/ consult with principal investigators on experimental planning and data evaluation. (5%)
8. Oversee biorepository laboratory supply inventory, equipment and maintenance. Work with administration to monitor budget allowance for biorepository. (5%)
9. Manage the implementation of patient recruitment at regional community hospitals in order to recruit a robust patient population with great breadth (Travel 2% to 3% weekly, local). Provide input and recommendation to Digestive Health Research Institute (DHRI) principal investigators on best practices to extend recruitment efforts. (5%)
10. Direct and oversee the work of summer students and/or trainees. Train assigned stakeholders on human subjects research and ensure all proper institutional training/documentation has been received prior to initiation of work on DHRI protocols. Teach postdoctoral scholars/fellows and trainees biobanking best practices. (5%)
11. Utilize data collected to co-author research projects. (5%)
Perform other duties as assigned. (5%)
Department: Daily contact with supervisor to discuss research.
University: Occasional contact with other departments to share information.
External: Contact with University Hospitals physicians and staff to discuss research. Limited contact with vendors to exchange information.
Students: Contact with student employees and trainees to maintain workflow.
This position may supervise research assistants and/or technicians. This position will supervise and direct the work of summer students and/or trainees. This position will train postdocs and/or pre-doc students on human subjects research.
Experience: 5 to 8 years of related experience required.
Education/Licensing: Bachelor’s degree in science required, Master’s degree preferred. CREC – Human Subjects Certification preferred.
1. Knowledge and understanding of commonly used concepts, practices and procedures within clinical research and biobanking.
2. Experienced in patient interaction, education and assisting physicians with patient visits; proven ability to deliver quality patient care.
3. Self-motivated, professional with clinical and didactic skills.
4. 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.
5. Excellent organization skills; ability to effectively multi-task, prioritize plan and meet deadlines. Must demonstrate attention to detail and accuracy, time management skills and follow-through.
6. Excellent customer service skills; ability to maintain effective working relationships and address the potential and current needs of biorepository customers.
7. Effective problem-solving skills; must demonstrate excellent analytical skills, sound judgment and good decision-making.
8. Must demonstrate flexibility and ability to work under pressure; must be able and willing to conform to shifting priorities, demands and timeline.
9. Willingness and ability to rely on instructions and pre-established guidelines to perform the functions of the job; must demonstrate the ability to successfully follow directions, adhere to study protocols and meet unexpected challenges.
10. Ability to operate laboratory equipment.
11. Must demonstrate willingness to learn and apply new theories as well as responsibilities; must be a quick learner who adapts easily to new situations and enjoys challenges.
12. PC skills, including Microsoft Office Suite (Word, Excel, Access, PowerPoint).
13. Experienced in creating and maintaining databases.
14. Must be able and willing to maintain a high standard of personal cleanliness and utilize protective gear to protect the health of patients.
15. Ability to meet consistent attendance.
16. Ability to interact with colleagues, supervisors and customers face to face.
General clinical and laboratory environment. The employee is exposed bloodborne pathogens, chemical, laser, radioactive materials, select agents and commercial products. This position will be required to attend the following trainings: Phlebotomy Training, Bloodborne Pathogen Safety Training, Handling & Shipping of Hazardous Materials Training, Laboratory Safety Training, Successful completion of Clinical Research Compliance and Education Program is also required.