Job Posting: This position functions as a Clinical Research Coordinator providing support for clinical research protocols. The Clinical Research Coordinator will assist the Research Department with all aspects of clinical research. This individual will interact with subjects, clinic and research staff, laboratory staff, medical professionals, and pharmaceutical staff. ESSENTIAL DUTIES AND RESPONSIBILITIES 1. Responsible for administrative functions of research studies. 2. Maintains comprehensive knowledge of assigned research protocol to coordinate the comprehensive and compliant execution of assigned protocols in accordance with research governing entity requirements, including but not limited to Sponsor, FDA and IRB requirements. 3. Works with PIs and Research Nurses to ensure the completion and maintenance of consent forms, case report forms, SAE's and source documents to ensure that research is being conducted according to FDA, HSPC, HIPAA and other agency guidelines 4. Reviews protocols and informed consent forms for completeness and compliance with regulations. 5. Reviews all clinical study records including informed consents, to ensure complete documentation in compliance with regulations. 6. Assists in the preparation of new protocols. 7. Coordinate and follow all protocol related procedures. 8. Coordinate with data managers for completion of case report forms (CRF's) and data entry for clinical research projects as needed. 9. Provide support (including administrative/clerical) and information to subjects, staff, and external sources related to current research projects. 10. Maintain scheduling of pre-study testing, treatments, outside labs, scans, biopsies and other tests for all clinical research visits. 11. Attend meetings and conferences related to research activities. 12. Act as liaison and coordinate efforts with other departments and personnel. 13. Maintain research charts and subject records have proper source documentation. 14. Obtain follow up information and reports for all subjects on study. 15. Obtain medical records, death certificates and death information for all subjects as needed. 16. Follow up subjects as needed by telephone, to insure compliance with treatment guidelines. 17. Interact appropriately with other members of the clinical team and office personnel, communicating in a highly professional manner at all times. 18. Maintain appropriate records of clinical activities. 19. Advise supervisor, physicians, administrator of potential or actual problems. 20. Participate in planning, workshops, evaluation meetings, and seminars, educational or administrative meetings as necessary or requested. 21. Review and adhere to department policies and procedures to maintain proficiency in operating guidelines. 22. Maintain confidentiality when performing all duties and responsibilities. 23. Demonstrate 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 patients vital signs and recording them legibly in the patient's medical records and obtaining EKGs. 24. Seek guidance and direction, as necessary, for the successful completion of job duties, ask appropriate questions when in doubt. 25. Maintain appropriate records, notification of the time worked, vacations, seminars, and professional time commitments related to this position. 26. Establishes and coordinates logistical aspects of clinical research projects to achieve project objectives, including project planning, projecting resource requirements, and developing systems to ensure protocol compliance and patient safety. 27. Acts as a liaison with Principal Investigators, pharmaceutical company representatives or other project funding organizations to monitor and update project progress. 28. Facilitates patient screening, recruitment and scheduling, initiating research patient records, administration of questionnaires, maintaining database Excel spreadsheet
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. The 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 representatives and other project personnel. Must demonstrate excellent communication skills, written and verbal, and have the ability to be consistently accurate. Ability to multi-task and manage time efficiently and set appropriate priorities. EDUCATION and/or EXPERIENCE 1 year of experience as a CRC is preferred. Experience in federal grant proposal development and grant submissions preferred Knowledge of IRB clinical research application procedures preferred Certification through SoCRA or ACRP is preferred A Bachelor's Degree in science or a science-related field is strongly preferred CERTIFICATES, LICENSES, REGISTRATIONS Basic Life Support Certification (BLS) Certification through SoCRA or ACRP is preferred PHYSICAL DEMANDS 1. Have moderate sitting/walking/standing 2. High volume of patient interaction 3. Prolonged view of computer screen 4. Lifting, pushing, pulling up to 20lbs 5. Requires good physical and emotional health 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. While performing the duties of this job, the employee may be exposed to fumes or airborne particles and toxic or caustic chemicals. The noise level in the work environment is moderate.
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.