Job Posting: JOB SUMMARY: The IRB Analyst works under the supervision of the Manager, IRB Operations & Education. The IRB Analyst is primarily responsible for the management of a caseload of applications submitted for IRB review. In this capacity, the IRB analyst must demonstrate sound judgment, as well as analytical, organizational, and time management skills. The assigned job responsibilities require a firm foundation in the guidance and regulations that govern the inclusion of human subjects in research. The IRB Analyst performs a detailed analysis of all applications submitted for IRB review. The IRB Analyst reviews each submission, verifying that all institutional requirements have been met, and determining whether applicable regulations and policies are appropriately addressed. The IRB Analyst must consider the nature of the proposed research, make a determination regarding the necessary review process, and share this recommendation with the IRB reviewers. The IRB Analyst attends IRB meetings to provide technical support and guidance on regulatory matters. The IRB Analyst documents the Board's determinations in the drafting of comprehensive meeting minutes and correspondence to investigators that effectively outline the concerns, rationale, and technical questions of the IRB. The IRB Analyst is also responsible for conducting evaluations of investigator's response to identify potential issues for IRB reviewers and advise as to whether the requirements for IRB approval have been met. The IRB Analyst is responsible for documenting the review process through complete and timely entries in WEBRIDGE, the IRB online submission and protocol tracking system. The IRB Analyst is the primary point of contact with the research community. Utilizing expertise in regulatory matters and IRB policies, the IRB Analyst assists investigators in the preparation of their IRB applications and informed consent forms. The IRB Analyst participates in departmental quality improvement activities by identifying needs in department operations and making recommendations for their improvement. Cedars-Sinai will consider for employment qualified applicants with criminal histories, in accordance with the Los Angeles Fair Chance Initiative for Hiring.
Qualification Requirements/Preferences: Education Certifications/Licensure Experience Physical Abilities MINIMUM JOB REQUIREMENTS/COMPETENCIES: A Bachelor's degree, with a minimum of 2-3 years experience in a structured business office. A working knowledge of the federal regulations governing human subjects research is preferred. A certification of "Certified IRB Professional" is preferred. Excellent writing skills are needed to generate clear, precise, detailed and grammatically correct technical letters, memos, and reports. Exceptional analytical ability is necessary in order to apply knowledge of federal regulations and institutional policy to research proposals. Superior organizational skills and attention to accuracy are required in order to effectively and efficiently manage multiple priorities and a high volume workload. Strong interpersonal and communication skills with a capacity to work well with multiple constituencies of various educational and social backgrounds. Proficient in the use of multimedia hardware and software applications, including the use of Windows, database, spreadsheets and word processing. Ability to complete assignments within establish departmental processing targets. Must be motivated and have the ability to work under pressure to meet deadlines. Must know when to refer issues to Supervisor and have the ability to make accurate and appropriate independent judgments, but be able to accept direct supervision. Ability to meet production within established time and quality standards is required. PHYSICAL DEMANDS: Physical ability and perceptive acuity to perform functions.
Routine office environment with prolonged sitting, telephone use, typing, and keyboarding.
Able to travel to various locations on campus to meet with other personnel as requested.
Able to maneuver on tight spaces, to bend, reach, and stoop.
Frequent sitting, standing and walking and bending; extensive use of office equipment, such as computers, scanners, cameras and phones; occasional lifting of materials up to 25 pounds for distances to 10 feet.
Responsiveness to auditory alarms and communicating devices including telephones, beepers, fire alarms, mechanical failure alarms. WORKING CONDITIONS: Ability to work in a fast paced, high volume environment with frequent interruptions. ORGANIZATIONAL EXPECTATIONS: Demonstrates behavior, which supports the Cedars-Sinai Health System mission. Attends required orientation and training seminars. Meets production standards within established time requirements. Work product and performance meet quality standards. Demonstrates respect and positive interpersonal skills with patients, clients, the public, managers, and co-workers; a team player. Maintains confidentiality of patient care and business matters. Observes time, attendance and dress code standards. Protects the safety of others and of the physical plant and equipment, following institution policies, and fire, safety, and infection control regulations. The above statements are intended to describe the general nature and level of work being performed. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees classified in this job. EEO / AA / F / M / Veteran / Disabled
Providing healthcare for more than 100 years, Cedars-Sinai has evolved into one of the most dynamic and highly renowned medical centers in the world. Along with caring for patients, Cedars-Sinai is a hub for biomedical research and a training center for future physicians and other healthcare professionals. This attracts exceptional talent to Cedars-Sinai, including world-renowned physician-scien...tists who seek a place where they can both conduct research and see patients--the ideal formula for discovery and its translation into cures. Our patients benefit from access to doctors at the top of their fields, and our researchers have an ideal community in which to study the impact of healthcare challenges, and reflect that knowledge in their research. The greater Los Angeles area in which Cedars-Sinai resides possesses unparalleled cultural and ethnic diversity which offers outstanding opportunities for translational and clinical research and a dynamic environment for medical education.Although community based, Cedars-Sinai is a major teaching hospital affiliated with the David Geffen School of Medicine at the University of California, Los Angeles (UCLA). Cedars-Sinai has highly competitive graduate medical education programs in more than 50 specialty and subspecialty areas, a graduate program in biomedical sciences and translational medicine, a clinical scholars program directed towards junior physicians with aspirations to become clinical scientists, and post graduate training opportunities.There are more than 250 full-time faculty members at Cedars-Sinai. The voluntary medical staff, comprised of more than 2,200 specialty board-certified or board-qualified physicians, represent all of the specialties and subspecialties and collaborate with full-time medical staff in the teaching responsibilities of the graduate medical education programs.