- Knowledge of all regulatory requirements and institutional requirements when conducting the study protocol(s).
- Participant recruitment including pre-screening, new potential participant follow-up and collaboration with the Investigators.
- Coordinates research subject informed consent and entry into appropriate research studies ensuring that all inclusion and exclusion criteria are met.
- With the Investigator, conducts informed consent conversation with the potential participant and/or caregiver.
- Coordinates and/or performs a variety of procedures/tests including, but not limited to, laboratory tests/phlebotomy, vital signs, ECG/EKGs, imaging studies, evaluations, as well as other needs as outlined in the study protocol(s).
- Obtains medical history, medical records and all other procedures outlined in the study protocol(s) within the allowed timelines.
- Responds to patient inquiries via phone or in person in a timely manner.
- Processing and shipments of samples collected as outlined in the study protocol(s).
- Provides participant education, with the Investigators, research pharmacist, and other members of the research study team, such as study specific procedures, diary/study log, proper dosage/administration, and specific restrictions as outlined in the study protocol(s).
- Completes case report forms, data entry, and maintains source documentation for all study participants.
- Triages, tracks and reports adverse events and deviations to the Investigator as well as the sponsor and IRB in accordance to their requirements.
- Coordinates research monitor visits and responds to all data queries in a timely manner.
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Clinical Research Specialist - Phoenix, United States - CommonSpirit Health
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Description
Overview:
Hello humankindness
Located conveniently in the heart of Phoenix, Arizona, St. Joseph's Hospital and Medical Center is a 571-bed, not-for-profit hospital that provides a wide range of health, social and support services. Founded in 1895 by the Sisters of Mercy, St. Joseph's was the first hospital in the Phoenix area. More than 125 years later, St. Joseph's remains dedicated to its mission of caring for the poor and underserved.
We are extremely proud to be a nationally recognized center for quality quaternary care, medical education and research. St. Joseph's includes the internationally renowned Barrow Neurological Institute, Norton Thoracic Institute, Cancer Center at St. Joseph's, Ivy Brain Tumor Center, and St. Joseph's Level I Trauma Center (which is verified by the American College of Surgeons). The hospital is also a respected center for high-risk obstetrics, neuro-rehabilitation, orthopedics, and other medical services. St. Josephs is considered a sought-after destination hospital for treating the most complex cases from throughout the world. Every day, approximately 20 percent of the hospitals patients have traveled from outside of Arizona and the United States to seek treatment at St. Josephs.
U.S News & World Report routinely ranks St. Joseph's among the top hospitals in the United States for neurology and neurosurgery. In addition, St. Joseph's boasts the Creighton University School of Medicine at St. Joseph's, and a strategic alliance with Phoenix Children's Hospital.
St. Joseph's is consistently named an outstanding place to work and one of Arizona's healthiest employers. Come grow your career with one of Arizona's Most Admired Companies.
Look for us on Facebook and follow us on Twitter.
For the health of our community ... we are proud to be a tobacco-free campus.
Responsibilities:Barrow Neurological Institute is the most experienced pituitary center in the Southwest. We are serving patients from across the nation and constantly striving to help contribute to scientific understanding and therapeutic research in this field. This is an exciting and unique opportunity to be a part of the Barrow Neuroendocrine/ Pituitary Research Team.
Clinical Research Specialists hold a key role in supporting the Investigators/Study Doctors in the execution of research protocols. Responsibilities will vary based on the needs of the research as well as the participant needs in accordance with the Food and Drug Administration (FDA), Office for Human Research Protections (OHRP), Good Clinical Practices (GCP), Institutional Review Board (IRB), HIPAA regulations and institutional requirements, including but not limited to:
Requirements:
Minimum 2 years related experience required.
Competent in computer skills including the Microsoft Office products required.
Associates degree in related field or an equivalent combination of relevant education and/ or job-related experience in lieu of degree required.
Preferred:
Three (3) years clinical research experience preferred
Bachelor's Degree in related field preferred.