| Requisition #: | M10860 |
| Working Title: | Clinical Research Coord |
| Business Entity: | MDN - Medical Delivery Network |
| Cost Center # - Cost Center Name: | 0162200 - Angeles Research |
| City: | Los Angeles |
| Job Category: | Clinical and Research |
| Job Specialty: | Other Institutes |
| Position Type: | Regular-F/T |
| Shift Length: | 8hr |
| Hours: | 8:00 a.m. - 5:00 p.m. |
| Days: | Monday - Friday |
| Shift Type: | Day |
| Weekends: | None |
| Job Posting: | The Clinical Research Coordinator provides administrative support for Principal Investigators, including assisting with coordination, implementation and conduct of multiple research projects in the areas of cardiology and cardiac surgery, fully integrated with applicable research management systems and processes. This includes facilitating screening, recruitment, and enrollment of patients, as well as facilitating the consenting process. The individual will work under the PI to coordinate, implement and monitor progress and completion of clinical studies/trials. They will assist in development of protocols, informed consent forms, regulatory submissions, budgets, payment tracking systems, manuscripts and clinical research forms as necessary. ESSENTIAL DUTIES AND RESPONSIBILITIES: 1. Responsible for administrative functions of multi-site research studies. 2. Develops and 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. Coordinates institutional, pharmaceutical and internal audits, including facilitating third party study monitoring. 5. Responsible for assisting with IRB applications for the department for both study initiation and renewal. 6. 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. 7. Acts as liaison with Principal Investigators, pharmaceutical company representatives or other project funding organizations to monitor and update project progress. 8. Facilitates patient screening, recruitment and scheduling, initiating research patient records, administration of questionnaires, maintaining database Excel spreadsheets, completion of case report forms, performing data edits with P.I.’s research staff, pharmaceutical company monitors, etc. 9. Provides assistance with research project budget development, including identifying and classifying routine care vs. research related care. 10. Participates in the conceptualization and design of future projects, including drafting concept sheets, protocols and research proposals. 11. Provides research project management expertise for entire project lifecycle, including process design, proposal development, oversight of contracting, and study implementation in compliance with regulatory and HIPAA guidelines. 12. Maintains system for monitoring and maintenance of patient data records. 13. May provide technical support for the preparation of grant proposals, publications, presentations and special projects. 14. Participates in weekly research staff meetings. 15. Protects rights and research data of research volunteers, including medical records, data, etc. Obtain necessary consent forms, or HIPAA information forms as needed, in research process. 16. Performs other related duties as assigned or required. |
| 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 Bachelor’s degree required, preferably in a health science or related discipline area and . Minimum of three (3) years experience in clinical research coordination or CRC certification, or equivalent education and related experience. Experience working in cardiology or transplantation disciplines a plus. Experience in federal grant proposal development and grant submissions, and knowledge of IRB clinical research application procedures 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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. |
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