Marian Regional Medical Center, located in Santa Maria, California, is rated among the top 10% in the nation for cardiac care, and is a designated STEMI Receiving Center (ST Segment Elevation Myocardial Infarction) in Santa Barbara County. Santa Barbara County STEMI receiving programs earned the Silver Award from the American Heart Association for excellence in patient care. Marian has achieved prestigious designation as a Primary Stroke Center by the Joint Commission. In addition, Marian has received the Healthgrades Distinguished Hospital Clinical Excellence Award. The medical center’s cancer program is distinguished as the only comprehensive Community Cancer Center on the Central Coast. The need to meet the demand for quality, technologically-advanced care for a growing community led Marian to open its doors to a new state-of-the-art, 191-bed facility in the spring of 2012. The new facility houses the largest and most comprehensive perinatology/neonatology program on the Central Coast providing the most compassionate, quality care to the littlest of patients. Marian is a Dignity Health member of the Central Coast, which also includes Arroyo Grande Community Hospital in Arroyo Grande, CA and French Hospital Medical Center in San Luis Obispo, CA, St. John’s Regional Medical Center in Oxnard, CA and St. John’s Pleasant Valley in Camarillo, CA. Dignity Health of the Central Coast is an integrated network of top quality hospitals, physicians from the most prestigious medical schools, and comprehensive outpatient services including primary care offices, premier ambulatory surgery centers, technologically-advanced laboratories and imaging centers and a full service home health agency; all recognized for quality, safety and service. Each hospital is supported by an active philanthropic Foundation to help meet the growing health care needs of our communities. Learn more at http://www.dignityhealth.org/marianregional/
Dignity Health Home Health promotes the mission and values of Dignity Health, a vibrant, national health care system known for service, chosen for clinical excellence, standing in partnership with patients, employees and physicians. We seek to improve the health of all communities served. With three locations along the beautiful Central Coast of California, we provide quality care to patients in the home setting from San Luis Obispo County to Northern Santa Barbara County. We have offices in Atascadero, Santa Maria and Lompoc, meeting care needs of the diverse communities. Dignity Health Home Health is a Medicare Certified, State licensed agency that earned deemed-status accreditation by The Joint Commission. Our community based palliative care program was recently certified by the Joint Commission. We proudly serve patients in various stages of life on their health journey.
The Clinical Research Coordinator (CRC) works with the Dignity Health Research Institute Market Clinical Research Manager (MCRM), Principal Investigators, co- and sub-investigators, clinical and ancillary departments, IRBs, and industry or government sponsors of research to plan, coordinate, implement and complete clinical trials and other research projects managed by the Dignity Health Research Institute. The incumbent independently manages all aspects of multiple clinical trials or other research projects as assigned, including but not limited to: research participant recruitment, screening and enrollment; completion of protocol required visits and procedures; collection and reporting of data; coordination of and participation in sponsor monitoring visits or federal audits; query resolution; adverse event reporting, source documentation and research record development and maintenance; study drug accountability; specimen collection, processing and shipment. The incumbent ensures compliance of the research program and its studies with all applicable federal and state regulations, as well as Dignity Health policy.
This positon is responsible for maintaining quality standards for responsive service and professional documentation in compliance with Dignity Health policies and procedures, and federal and state laws and regulations, all which is consistent with the Mission and Values of Dignity Health. This is an exempt position that may require occasional overnight travel and weekend assignments.
- Minimum 3 years of experience conducting clinical trials required
- Worked as primary research coordinator for at least 5 drug or device trials
- Minimum 3 years of experience interacting with patients in a healthcare setting required.
- Thorough knowledge and understanding of research regulatory requirements involving human subjects research, including FDA, OHRP and GCP requirements required.
- Experience in implementation of research protocols and clinical trials processes required.
- Experience in preparing and maintaining regulatory documents and other IRB-related study documentation required.
- Experience using electronic data capture software required; Clinical Trial Management Systems (CTMS) preferred.
- Experience with Microsoft Office software required.
- Knowledge of medical terminology required.
- Lab processing experience required.
- Bachelor’s degree in a science or health-related field or a combination of education and/or additional job related experience in lieu of the degree.
- Current certification (CCRP or CCRC) by the Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP) required.
- Current certificate of Human Subjects Protection and Good Clinical Practice training required.
- Understanding of ethical principles, culture and values of medical research.
- Critical thinking skills, decisive judgment and the ability to work with minimal supervision.
- Demonstrated ability to work independently yet collaboratively with all members of the research community including physicians/principal investigators, research team members, IRBs, hospital and clinic personnel, and sponsors of research.
- Demonstrated ability to perform all research coordination duties for multiple clinical trials simultaneously.
- Knowledge base to provide education to patients, families, and other staff regarding clinical and patient care issues, including patients who may have a terminal disease.
- Excellent interpersonal and communication skills, both verbal and written, required.
- Highly motivated and flexible, with the ability to adjust to rapidly changing priorities and new projects.
- Strong attention to detail and ability to multi-task, organize and prioritize multiple projects.
- Ability to formulate logical and objective conclusions and make recommendations for effective solutions.