Description
This on-site position serves as a Subject Matter Expert (SME) in clinical research and is responsible for the coordination and management of clinical studies at Intermountain Health.
Working in a patient-facing environment, this role collaborates closely with clinical investigators, physicians, department leadership, regulatory coordinators, sponsors, and other stakeholders to ensure the efficient execution of research studies, regulatory compliance, and high-quality participant care throughout the research process.
Work Schedule Monday–Friday, 8:00 a.m. – 5:00 p.m.
Essential Functions
- Support various research studies across the Intermountain system, working on complex or large projects with limited supervision, demonstrating high competency in clinical research.
- Provide support and mentorship to Clinical Research Coordinators I, reinforcing training and knowledge of study protocols and procedures.
- Educate and disseminate information about research projects, communicating with study teams and physicians about protocols and timelines.
- Utilise GCP guidelines for screening, assessing participant eligibility, conducting study procedures, data entry, and patient monitoring, and participate in oversight visits.
- Help facilitate strategies for study recruitment, participant retention, and study execution, performing ongoing quality assurance and evaluations at study completion as requested.
- Ensure compliance with best practices for transmitting patient information as required by study approvals and protocols, supporting study team and investigator adherence to GCP guidelines.
- Train Clinical Research Coordinator I on basic techniques of clinical research coordination, FDA Good Clinical Practices (GCP), and clinical research Standard Operating Procedures (SOPs), maintaining compliance with Intermountain policy, research sponsors, and Federal regulations.
- Collect, process, maintain, and ship lab samples, demonstrating laboratory competency and compliance with SOPs.
- Perform other duties as assigned (e.g., data entry, expense tracking, patient chart reviews).
- May be required to take on-call assignments, work weekends and overtime.
Skills
- Research Protocols
- Independent worker and self-starter
- Critical thinking and decision making
- Detail-oriented
- Personable
- Highly organised
- Documentation
- Verbal and written communication
- Patient information
- Clinical Information systems
Minimum Qualifications
- Experience in a role requiring the ability to demonstrate proficiency with Microsoft and database applications.
- Experience using laboratory protocol, systems, and documentation techniques.
- Demonstrated experience in a healthcare, academic or research-related setting or research-related setting working with patients.
Preferred Qualifications
- Bachelor's Degree in a clinical or life science field, business, or healthcare operations.
- Demonstrated professional experience in a clinical research role requiring use of laboratory protocol, systems and documentation techniques, detailed knowledge of human subject research regulations, strong demonstrated attention to detail and ability to adhere to policies and procedures.
- Experience in a healthcare or hospital setting.
- A multi-disciplinary knowledge of both health care and research.
- Expertise and/or experience in the clinical specialty or area of focus related to this research role (i.e., cardiology, pulmonary, oncology, women and newborn, etc.).
Physical Requirements
- Ongoing need for employee to see, read and understand information, labels, assess patient needs, operate monitors, identify equipment and supplies.
- Frequent interactions with patient care providers, patients, and visitors that require employee to verbally communicate as well as hear and understand spoken information, alarms, needs, and issues quickly and accurately.
- Manual dexterity of hands and fingers to manipulate complex and delicate equipment with precision and accuracy.
- Expected to bend, lift, and carry patient files, documents, equipment, and supplies.
- Remain sitting or standing for long periods of time while interacting with others or to perform work on a computer, telephone, or other equipment.