Job Posting: The Clinical Research Supervisor is responsible for organizing and coordinating research office operations and staff in order to ensure departmental effectiveness and efficiency in the conduct of clinical research activities. This includes providing direction and oversight to research staff, as well as direct involvement with project initiation, implementation and close-out. The Clinical Research Supervisor will be specifically tasked with ensuring compliance with all regulatory (IRB, FDA, NIH) and Cedars-Sinai Health System policies as applicable. Clinical Research Supervisor is also responsible for protocol review and budget development and coordinates with CSMC (Cedars-Sinai Medical Center) contracts officers and sponsors of research to facilitate execution of research agreements and grant awards. Clinical Research Supervisor is responsible for the ongoing regulatory and budgetary requirements of clinical research, including interim reporting, annual renewals, internal and external audits, invoice generation, payment tracking and fund management. In collaboration with Senior Manager and Principal Investigators, Clinical Research Supervisor may plan and coordinate strategies for improving efficiency, action plans to improve quality, and training and education of personnel. ESSENTIAL DUTIES AND RESPONSIBILITIES: Serve as primary point of contact for clinical studies. Monitor research projects through all phases. Work with investigators to ensure optimal compliance and performance of research protocols, regulatory requirements, and ethical practice. Assists in the development, review, and revision of standard operating policies and procedures in collaboration with senior management. Provides day-to-day oversight of research staff. Participates in monthly Senior Staff meetings. Supervisory Responsibilities The Clinical Research Supervisor directly supervises research personnel (study coordinators, research associates, research assistants), and carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include: Interviewing and hiring new employees Facilitating new employee orientation/training Appraising staff performance, including rewarding and disciplining employees Identifying and implementing necessary corrective actions Addressing patient, physician, and staff concerns and resolving problems accordingly. Ensuring a safe environment for staff and patients Understanding and enforcing the organization's patient care and research standards and requirements, including areas such as safety, privacy and quality assurance as is appropriate. Assist Senior Management with the monitoring of performance measures and designing methods for improving the research program. Project Start Up Responsibilities 1. Participates in Sponsor Pre-Study and Site Initiation Visits. 2. Conducts protocol review. 3. Ensures the submission of appropriate internal documentation to SRFA (Sponsored Research and Funds Administration) for contract execution. Maintain communication with contracting officers and sponsors of research during the budgeting and negotiating process. 4. Identifies and collaborates with other departments for research services. 5. Ensures the development of research project budgets based on protocol requirements and Cedars-Sinai published research costs, confirming that all anticipated costs are appropriately accommodated and that research protocol, research budget and research subject informed consent documents are consistent. 6. Completes grant applications for federally funded research. 7. Prepares and submits protocols and supporting documents to regulatory bodies such as FDA and IRB. 8. Collecting and submitting to sponsors essential documents required for site activation. 9. Facilitates the preparation of consent and HIPAA documents for IRB submission. 10. Completes IND (Investigational New Drug) applications as needed. 11
Qualification Requirements/Preferences: Education Certifications/Licensure Experience Physical Abilities QUALIFICATIONS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This job requires a strong understanding of Good Clinical Practice in Clinical Trials. In addition, strong interpersonal skills are needed to work effectively with patients, their physicians and/or families; pharmaceutical company representative and other project personnel. Must demonstrate excellent communication skills, written and verbal, and have the ability to be consistently accurate. Require the ability to multi-task and manage time efficiently. The position also requires the following: High energy with a focus on meeting deadlines; Able to prioritize and maintain progress on multiple scientific projects; Supportive of finding creative solutions to complex scientific and business challenges; Customer focused in a way that ensures desired outcomes are achieved; Collegial and highly participative at all levels; Focused on providing cutting edge technology that solves real business challenges and ultimately produces better treatment alternatives for patients. EDUCATION and/or EXPERIENCE: Requires MS/MA/MPH degree, preferably in a scientific/healthcare field. Requires 3-5 years related experience in Pharmaceutical/Biotechnology or Contract Research Organization (CRO) or academic research. Significant supervisory experience in a clinical setting will also be considered. Experience in federal grant proposal development and grant submissions, and knowledge of IRB clinical research application procedures preferred. Must demonstrate the ability to lead and supervise personnel constructively and with fairness. Must have proven track record with customer service, training, and ability to motivate others to effect positive change. Must have ability to demonstrate initiative and work independently in a dynamic environment as well as to accomplish multiple tasks within an aggressive time frame. Computer and database skills including graphics and spreadsheets, such as Excel, MS Access and PowerPoint are essential. PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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.