Great Falls, Montana
Posted: 01-Oct-25
Location: Remote, Oregon
Categories:
Internal Number: R1020921
Level 1 Pay range: $25.18 - $37.77 per hour.
Level 2 Pay range: $27.20 - $40.79 per hour.
About St. Charles Health System:
St. Charles Health System is a leading healthcare provider in Central Oregon, offering a comprehensive range of services to meet the needs of our community. We are committed to providing high-quality, compassionate care to all patients, regardless of their ability to pay. Our values of compassion, excellence, integrity, teamwork, and stewardship guide our work and shape our culture.
What We Offer:
Competitive Salary
Comprehensive benefits including Medical, Dental, Vision for you and your immediate family
403b with up to 6% match on Retirement Contributions
Generous Earned Time Off
Growth Opportunities within Healthcare
ST. CHARLES HEALTH SYSTEM
JOB DESCRIPTION
TITLE: Clinical Research Coordinator I
REPORTS TO POSITION: Research Manager
DEPARTMENT: Research
DATE LAST REVIEWED: November 15, 2024
OUR VISION: Creating Americas healthiest community, together
OUR MISSION: In the spirit of love and compassion, better health, better care, better value
OUR VALUES: Accountability, Caring and Teamwork
DEPARTMENTAL SUMMARY: St. Charles Research Department conducts clinical trials for promising new treatments and therapies in a wide variety of medical fields, including cancer treatment and prevention, cardiovascular disease and supportive care.
POSITION OVERVIEW: The Clinical Research Coordinator I is responsible for conducting clinical trials in compliance with FDA regulation, ICH Guidelines and applicable industry standards. The Clinical Research Coordinator 1 will oversee up to ten clinical trials as the main research coordinator.
This position does not directly manage other caregivers, however may be asked to review and provide feedback on the work of other caregivers.
ESSENTIAL FUNCTIONS AND DUTIES:
Maintains surveillance system to identify potential subjects for study eligibility, prescreen patients, and assists physicians in determining eligibility.
Obtains informed consent according to GCP and ICH guidelines.
Performs study procedures and assessments following protocol specific guidelines.
Assures research is conducted in an ethical and safe manner according to FDA, ICH and St. Charles Health System guidelines.
Adheres to St. Charles Health Systems compliance plan.
Attends IRB meetings as requested by the IRB.
Supports the processing of study alerts, protocol revisions, amendments, accrual suspension notices, informed consent modifications, product information and advertisement, and related memoranda.
Supports the modification of template informed consent forms for local application in compliance with federal guidelines for patients in lay language at appropriate reading level
Prepares for and participates in required sponsor and regulatory audits.
Attend Investigator meetings as required to assure seamless study start-up.
Assists with subject education and informed consent process, including tissue and genetics consent when indicated. Surveys for re-consent and obtains from eligible subjects.
Educates patients regarding protocol diagnostic tests and assists with appointments.
Process tissue/blood specimens and prepare it for shipment.
Manages treatment and follow-up schedules to assure protocol compliance.
Attends subject clinic visits and interacts with subjects and staff as appropriate to assist in protocol adherence.
Track study drug usage per protocol and oversee study drug supply.
Maintains subject research records including long-term follow up and reporting.
Participates in institutional research activities (committee meetings, Tumor Boards, Grand Rounds, other conferences, etc.) that are relevant to the Position.
Keeps current with new developments in research methodologies.
Participates in quality assurance program for St. Charles Health System and affiliated research partners.
Supports the vision, mission and values of the organization in all respects.
Supports Value Improvement Practice (VIP- Lean) principles of continuous improvement with energy and enthusiasm, functioning as a champion of change.
Provides and maintains a safe environment for caregivers, patients and guests.
Conducts all activities with the highest standards of professionalism and confidentiality. Complies with all applicable laws, regulations, policies and procedures, supporting the organizations corporate integrity efforts by acting in an ethical and appropriate manner, reporting known or suspected violation of applicable rules, and cooperating fully with all organizational investigations and proceedings.
Delivers customer service and/or patient care in a manner that promotes goodwill, is timely, efficient and accurate
May perform additional duties of similar complexity within the organization, as required or assigned.
EDUCATION:
Required: Bachelor of Science degree, or combination of college level education and Research experience to perform the full scope of position duties.
Preferred: Bachelor of Science degree in related field.
LICENSURE/CERTIFICATION/REGISTRATION
Required: Association of Clinical Research Professional (ACRP) or Society of Clinical research Associates (SOCRA) certification or must obtain within 2 years of full time employment. Current American Heart Association (AHA) Basic Life Support for Healthcare Provider certification.
Preferred: N/A
EXPERIENCE:
Required: None Required.
Preferred: Experience as a Clinical Research Coordinator. Experience dealing with multidisciplinary teams. Basic Clinical task knowledge.
ADDITIONAL POSITION INFORMATION: N/A
Schedule Weekly Hours:
40Caregiver Type:
RegularShift:
First Shift (United States of America)Is Exempt Position?
NoJob Family:
COORDINATOR CLERICALScheduled Days of the Week:
Monday-FridayShift Start & End Time:
Variable