Clinical Research Coordinator I

This position may be filled at the coordinator level 1 or level 2, based on experience/qualifications:

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 America’s 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 System’s 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 co