Clinical Research Coordinator

Intermountain Health

2d • Onsite

About The Position

The Clinical Research Coordinator (Phase 1 & CAR T Studies) is a specialized healthcare research professional responsible for managing the day-to-day operations of high-complexity, early-phase oncology trials, specifically focusing on Phase I drug trials and CAR T-cell therapy studies. This on-site position serves as a Subject Matter Expert (SME) in conducting clinical research studies of Intermountain Healthcare and is responsible for mastery in the coordination of clinical studies by working closely with clinical investigators, physicians, department leadership(s), regulatory coordinators, and sponsors. Works in a patient-facing environment with research participants. Work Schedule Core business hours: Monday–Friday, 8:00 a.m. – 5:00 p.m. Essential Functions Research Support: Support various research studies across the Intermountain system, working on complex or large projects with limited supervision, demonstrating high competency in clinical research. Mentorship: Provide support and mentorship to Clinical Research Coordinators I, reinforcing training and knowledge of study protocols and procedures. Education: Educate and disseminate information about research projects, communicating with study teams and physicians about protocols and timelines. Compliance: Utilize GCP guidelines for screening, assessing participant eligibility, conducting study procedures, data entry, and patient monitoring, and participate in oversight visits. Recruitment: Helps facilitate strategies for study recruitment, participant retention, and study execution, performing ongoing quality assurance and evaluations at study completion as requested. Information Management: 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. Training: Complies with and trains clinical research coordinator 1 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. Laboratory Operations: Collect, process, maintain, and ship lab samples, demonstrating laboratory competency and compliance with SOPs. Performs 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.

Requirements

• 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, academics or research related setting or research related setting working with patients.
• Three (3) years of 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.
• Demonstrated experience working in a collaborative team environment.
• Experience using word processing, spreadsheet, database, internet and e-mail and scheduling applications.
• Experience in a role requiring effective organizational skills; effective follow-through, and commitment to excellence, effective professional communication skills; Ability to communicate with others in a clear, understandable, and professional manner as well as strong interpersonal skills: Ability to work with personnel at all levels to gather information, communicate compliance requirements and handle complex issues within an often-sensitive political environment.

Nice To Haves

• Bachelor's Degree or higher from an accredited institution.
• Prior experience in a clinical research setting.
• Expertise or prior experience in the clinical area applicable to this research role (ie cardiology, pulmonary, oncology, women and newborn, etc.
• Bachelor's Degree in a clinical or life science field, business, or healthcare operations. A Degree must be obtained through an accredited institution. Education is verified.
• 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.
• Expertise and/or experience in the clinical specialty or area of focus related to this research role (ie cardiology, pulmonary, oncology, women and newborn, etc.)

Responsibilities

• 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.
• Utilize GCP guidelines for screening, assessing participant eligibility, conducting study procedures, data entry, and patient monitoring, and participate in oversight visits.
• Helps 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.
• Complies with and trains clinical research coordinator 1 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.
• Performs 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.

Benefits

• generous benefits package that covers a wide range of programs to foster a sustainable culture of wellness that encompasses living healthy, happy, secure, connected, and engaged.
• PEAK program supports caregivers in the pursuit of their education goals and career aspirations by providing up-front tuition coverage paid directly to the academic institution. The program offers 100+ learning options to choose from, including undergraduate studies, high school diplomas, and professional skills and certificates. Caregivers are eligible to participate in PEAK on day 1 of employment.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees