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 II for St. Charles Health System is responsible for conducting clinical trials in compliance with FDA regulation, ICH Guidelines and applicable industry standards. The Clinical Research Coordinator 2 will oversee ten or more 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: High School Diploma or GED.

Preferred: Bachelor of Science degree in related field preferred or equivalent research experience.

LICENSURE/CERTIFICATION/REGISTRATION

Required: Association of Clinical Research Professional (ACRP) Certified as a Clinical Research Coordinator; or must obtain within two years of full time employment. Current American Heart Association (AHA) Basic Life Support for Healthcare Provider certification.

Preferred: N/A

EXPERIENCE:

Required: Minimum 2 years research experience.

Preferred: Experience as a Clinical Research Coordinator. Experience dealing with multidisciplinary teams. Basic Clinical task knowledge.

PERSONAL PROTECTIVE EQUIPMENT

Must be able to wear appropriate Personal Protective Equipment (PPE) required to perform the job safely.

Job Type: Full-time

Pay: $23.78 - $32.82 per hour

Benefits:

• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Retirement plan
• Tuition reimbursement
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

COVID-19 considerations:
Measures to Minimize Risk to COVID-19: Even though we are seeing patients that have tested positive for COVID-19; St. Charles Health System has gone to great lengths to minimize your risk of exposure and help you feel comfortable during your visit.

Ability to commute/relocate:

• Bend, OR 97701: Reliably commute or planning to relocate before starting work (Required)

Education:

• High school or equivalent (Required)

Experience:

• Clinical research: 1 year (Required)
• Research: 1 year (Required)
• Clinical trials: 1 year (Preferred)

Work Location: One location

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