Job Posting: The Research Associate for regulatory affairs will assist the Research Department with all aspects of clinical research regulatory. This individual performs a wide variety of start-up activities integral to the successful application and acceptance of essential regulatory documents. The Research Associate is responsible for insuring timely submission of complete, accurate and neat documents to research sponsor, IRB, and contract research organizations, where applicable, and will interact with all clinic and research staff, laboratory staff, medical professionals, and pharmaceutical staff. ESSENTIAL DUTIES AND RESPONSIBILITIES: 1. Reviews protocols and informed consent forms for completeness and compliance with regulations. 2. Assists in the preparation of new protocols. 3. Utilizes current knowledge of GCP guidelines including protection of human subjects and regulations relevant to the performance and conduct of clinical trials. 4. Prepares and submits documents to the IRB which includes initial site submission forms, continuing review reports, initial and revised consents, amendments to the protocol, investigator brochures, protocol deviations, SAE reports, and IND safety reports, close-out reports, patients provided documents, such as QOLs, letters, and diaries. 5. Prepares and submits to sponsor FDA Form 1572, financial disclosures, CVs and medical licenses. 6. Maintains regulatory files (financial disclosures, FDA forms, CVs, medical license, etc.) for clinical trials. 7. Ensures site is utilizing the current regulatory documents including the informed consent forms, protocols, forms, and investigator brochures. 8. Participates in the weekly research meeting. 9. Maintains the SAE Table noting all SAEs reported to sponsor, including initial and follow-ups, as well as those reported to the IRB. 10. Ensures timely annual renewal of IRB approvals and consent forms for studies. 11. Maintains site delegation logs for all clinical trials. 12. Acts as regulatory liaison between the site and sponsor. 13. Prepares for all monitoring visits by ensuring that all documents are filed and organized as well as resolving all previous outstanding regulatory issues. 14. Reviews all signed informed consent forms to assure accuracy and makes corrections as needed. 15. Coordinates and prepares for institutional, pharmaceutical and internal audits. 16. Coordinates and collaborates with in-house and outside investigators and participating centers in multi-center studies to achieve research goals. 17. Maintains regulatory documents electronically on the online research folder for access by all research staff. 18. Provides support (including administrative/clerical) and information to staff, and external sources related to current research projects. 19. Attends meetings and conferences related to research activities. 20. Acts as liaison and coordinates efforts with other departments and personnel. 21. Interacts and communicates professional with other members of the clinical team and office personnel. 22. Maintains appropriate records of regulatory activities. 23. Advises supervisor, physicians, administrator of potential or actual problems. 24. Participates in planning, workshops, evaluation meetings, and seminars, educational or administrative meetings as necessary or requested. 25. Reviews and adheres to department policies and procedures to maintain proficiency in operating guidelines. 26. Maintains confidentiality when performing all duties and responsibilities. 27. Demonstrates willingness to assist co-workers in completion of daily tasks or special projects to support the department's efficiency including but not limited to, taking patient's vital signs and recording them legibly in the patient's medical records. 28. Seeks guidance and direction, as necessary, for the successful completion of job duties; Ask appropriate questions when in doubt. 29. Maintains appropriate records, notification of time worked, vacations, seminars,
Qualification Requirements/Preferences: Education Certifications/Licensure Experience Physical Abilities QUALIFICATIONS: 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. This individual must demonstrate excellent communications skills, written and verbal, and have the ability to be consistently accurate, as well as have the ability to multi-task and manage time efficiently. 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 individual with disabilities to perform the essential functions. The position also requires the following:
High energy with a focus in 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: One year of experience as a Regulatory Coordinator is mandatory. Certification through SoCRA or ACRP is preferred. In addition, a Bachelor's Degree BA/BS, preferably in a science-related field is required. Related experience in Pharmaceutical/Biotechnology, or Contract Research Organization (CRO) will also be considered. Experience in 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. Some demands include but are not limited to: moderate sitting/walking/standing, high volume of patient interaction, prolonged view of computer screen, lifting, pushing, pulling up to 20 lbs, and good physical and emotional health. 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.