Clinical Research Coordinator I

St. Charles Health System; United States; Remote; USD 60,000 - 80,000; Full time

Job summary

A leading healthcare provider in the United States seeks a Clinical Research Coordinator I to oversee clinical trials. The role involves ensuring compliance with regulations, obtaining informed consent, and managing research schedules. Applicants should have a Bachelor's degree and be willing to obtain specific certifications. This position offers a competitive salary with comprehensive benefits, including medical and dental coverage.

Benefits

Competitive Salary

Comprehensive benefits including Medical, Dental, Vision

403b with up to 6% match on Retirement Contributions

Generous Earned Time Off

Growth Opportunities within Healthcare

Qualifications

• Requires a Bachelor of Science degree or equivalent education and research experience.
• ACRP or SOCRA certification required within 2 years; current BLS for Healthcare Provider certification.

Responsibilities

• Conduct clinical trials in compliance with FDA regulation.
• Obtain informed consent and perform study procedures.
• Manage treatment and follow-up schedules and maintain research records.

Education

Bachelor of Science degree

Bachelor of Science degree in related field

Job description

Overview

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 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 organization’s 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: 40

Caregiver Type: Regular

Shift: First Shift (United States of America)

Is Exempt Position? No

Job Family: COORDINATOR CLERICAL

Scheduled Days of the Week: Monday-Friday

Shift Start & End Time: Variable