Fred Hutchinson Cancer Research Center

Clinical Research Monitoring Coordinator

Job Description:

New Opportunity in our Clinical Trials Support Office!

Monitor studies within the Cancer Consortium (Fred Hutchinson Cancer Research Center, University of Washington Medical Center, and Children’s Hospital Regional and Medical Center) as specified in the Data and Safety Monitoring Plan. Supports additional Clinical Trials Support Office projects.

SCOPE OF RESPONSIBILITIES:

The incumbent will work under the direction of the Clinical Research Monitoring Coordinator and the Clinical Trial Support Office Manager within the Research Trials Office performing responsibilities with a high level of independence.

JOB DUTIES:

1. Conduct monitoring visits to assure adherence to FDA and ICH guidelines, Good Clinical Practice (GCPs), Good Manufacturing Practice (GMP), SOPs, and study protocols.
2. Conduct monitoring visits to verify patient safety, the integrity of clinical data with respect to accuracy, accountability, documentation, and methods or procedures through review of CRFs/other data collection instruments, source documents, medical records, and regulatory documents.
3. Conduct monitoring visit to verify receipt, storage, preparation, and use or dispensing documents for investigational agents or devices.
4. Communicate to study staff all discrepancies noted and work with the study staff to assure that corrections and/or additions are made. Assist with the development of corrective action plans and the remediation of any deficiencies. Provides follow-up to ensure that corrective actions are successful.
5. Provide comprehensive monitoring visit reports to the Investigators and their staff, the Protocol Data and Safety Monitoring Committee (PDMC), and the Regulatory Affairs Manager.
6. Participates in the development of internal procedures and guidelines designed to support continuous improvement within the monitoring function.
7. Supports the Consortium investigators in the preparation and conduct of audits by FDA and other regulatory agencies.
8. Provide feedback to the Clinical Trials Support Office (CTSO) for identification of trends and ongoing training needs within the Consortium research community.
9. Maintain thorough knowledge in the field and regulatory requirements through attending related project meetings and symposia, reading related literature, and maintaining professional associations.
10. Work collaboratively with others from monitoring team.
11. Support the Clinical Research Monitoring Coordinator as required.
12. Perform other responsibilities as required.

The ideal candidate will possess the following qualifications:

BS/BA, minimum of five years of clinical monitoring required. Certification as a CRA is highly desirable. Must be knowledgeable in oncology or bone marrow transplant, FDA/ICH guidelines, Good Clinical Practices, clinical monitoring process and medical terminology. Excellent verbal and written communication skills and attention to detail are mandatory in order to effectively conduct audits and communicate results. Sound judgment and diplomacy when communicating sensitive information is key to this position. Must possess a high level of professionalism while interacting with all levels of staff. Excellent problem solving ability, flexibility, ability to work independently, develop strong professional relationships, good organizational skills, and proficiency in MS office are also key attributes for this position.

Requisition Number: #CB-015363

Job Type: 75-100% Time Position (30-40 hrs/week)

Job Category: Clinical/Admin

Compensation: Salary DOE+ excellent benefits

OPENING DATE: February 13, 2004

CLOSING DATE: Open Until Filled

You may also Fax or Mail your information as well, and of course you may apply in person. The address for this position is:

Office hours: Monday - Friday, 8:30 - 5:00.

TTY: (206) 667-6861 - for deaf and hard of hearing callers.

The Fred Hutchinson Cancer Research Center and The Seattle Cancer Care Alliance are equal opportunity employers, committed to workforce diversity.

Fred Hutchinson Cancer Research Center
Reference Job Code: CB-015363
Human Resources
823 Yale Ave N. (J1-105)
Seattle, WA 98109
Phone: (206) 667-4700
Fax: (206) 667-4051

Fred Hutchinson Cancer Research Center is an Equal Opportunity Employer

Submitted: 03/24/2004