Job Posting: The Clinical Research Associate I works directly with the Clinical Research team to coordinate and implement the study in accordance with all federal, local, FDA, IRB, and HIPAA guidelines and regulations. The role evaluates and abstracts research and ensures compliance with protocol and research objectives. The position is responsible for completing case report forms and/or entering clinical research data and/or assist with regulatory submissions to the IRB and/or study budget and patient research billing. This position requires limited patient contact. ESSENTIAL DUTIES AND RESPONSIBILITIES 1. May coordinate data for completion of case report forms (CRFs), either paper or electronic data capture and perform data entry for clinical research trials and projects. 2. May review all clinical study records to ensure complete documentation in compliance with regulations. 3. May prepare charts for monitoring visits. 4. May be responsible for answering sponsor queries in a timely manner. 5. May obtain physicians signatures on CRFs and other study documentation as needed. 6. May assist the research staff in meeting all data lock and query resolution deadlines. 7. May update outside sponsors as needed on query resolution, outstanding number of CRFs to be completed, etc 8. May act as liaison between research department and sponsor as needed to ensure timely CRF completion. 9. May maintain research charts and subject records. 10. May assist with regulatory submissions to the Institutional Review Board 11. May assist with clinical trial budgets and patient research billing 12. May assist with the management of the CTMS and accounts receivable and reconciliation 13. Attend meetings and telephone conferences related to research activities as needed. 14. Obtain medical records, death certificates and death information for all subjects as needed. 15. Interact appropriately with other members of the clinical team and office personnel, communicating in a highly professional manner at all times. 16. Participate in planning, workshops, evaluation meetings, and seminars, educational or administrative meetings as necessary or requested. 17. Review and adhere to department policies and procedures to maintain proficiency in operating guidelines. 18. Maintain strict patient confidentiality according to HIPAA regulations and applicable law 19. Demonstrate willingness to assist co-workers in completion of daily tasks or special projects to support the department's efficiency. 20. Seek guidance and direction, as necessary, for the successful completion of job duties; ask appropriate questions when in doubt. 21. Maintain appropriate records, notification of time worked, vacations, seminars, and professional time commitments related to this position. 22. Perform other duties as assigned.
Qualification Requirements/Preferences: Education Certifications/Licensure Experience Physical Abilities QUALIFICATIONS This job requires a general understanding of research objectives. 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.
Must have excellent oral and written communication skills with a must have quality of service attitude
Ability to communicate clearly, thoroughly, and concisely. Ability to respond to common inquiries or complaints from patients, team members, pharmacy sponsors, or regulatory agencies.
Able to work carefully and efficiently under stressful and or high demand situations EDUCATION and/or EXPERIENCE
1 year of experience in the field of clinical research is preferred
Bachelor's degree in biology or science-related field is preferred
1 year of experience in a medical office is preferred 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.