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Manager-CTC Admnistrative
Loma Linda University Health | |
United States, California, Loma Linda | |
August 07, 2022 | |
- Clinical Trial Center - (Full-Time, Day Shift) - Our mission is to participate in Jesus Christ's ministry, bringing health, healing, and wholeness to humanity by: Creating a supportive faculty practice framework that allows Loma Linda University School of Medicine physicians and surgeons to educate, conduct research, and deliver quality health care with optimum efficiency, deploying a motivated and competent workforce trained in customer service and whole person care principles and providing safe, seamless and satisfying health care encounters for patients while upholding the highest standards of fiscal integrity and clinical ethics. Our core values are compassion, integrity, humility, excellence, justice, teamwork and wholeness. The Manager-CTC Administrative will serve as an expert with extensive knowledge and experiences in clinical trial management, as well as understanding of rules and regulations and federal, state and local laws related to research. Manager will train junior staff and perform on pre-trial services. In addition, Manager will provide site training and resources for trial management to clinical departments. Manager will assist Director in resolving issues that prevent trial compliance and efficiency. Manager will collaborate extensively with pre-trail team, clinical trial site personnel (e.g., PI and study coordinator) and ancillary service providers to ensure that standard procedures are followed and trials are making good progress. Perform other duties as needed. Bachelor's Degree in health administration, public policy, or a health-related field required. Minimum of two years related clinical research, preferably in research administration focused on managing clinical trials. Minimum two years supervisory experience required. Experience may be considered in lieu of Degree. Active Registered Nurse (RN) or Respiratory Care Practitioner (RCP) preferred. Good Clinical Practice and Human subject protection certification may be completed within 90 days of hire date. Certification in Clinical Research may be completed within one year of hire date. Knowledge of FDA regulations, GCP, ICH guidelines, and NCD required. Able to read; write and speak with professional quality; use computer and software programs necessary to the position (e.g., Word, Excel, Power Point, Access); operate/troubleshoot basic office equipment required for the position. Relate and communicate positively, effectively, and professionally with others; provide leadership; be assertive and consistent in enforcing policies ensuring compliance with regulatory standards, rules and laws; work calmly and respond courteously when under pressure; lead, supervise, teach, and collaborate; accept direction. Communicate effectively in English in person, in writing, and on the telephone; think critically; work independently; perform basic math and statistical functions; manage multiple assignments; compose written material; work well under pressure; problem solve; organize and prioritize workload; recall information with accuracy; pay close attention to detail. Distinguish colors as necessary; hear sufficiently for general conversation in person and on the telephone, and identify and distinguish various sounds associated with the workplace; see adequately to read computer screens, and written documents necessary to the position. Additional Information
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