Responsible for all activities for oncology treatment, cancer control and diagnostic research protocols. Conducts follow-up and data management for subjects who have completed the active phase of their treatment protocols. Screen, educate, consent, enroll, and follow patients on cancer control protocols. Maintains records of subject enrollments and current files of all protocol documents. Maintain compliance with hospital and regulatory bodies’ guidelines for the conduct of clinical trials. 

Education:

• High school diploma required.

Licensure/Certification/Registry:

• LPN, CTR (Certified Tumor Registrar), or similar clinical licensure/certification highly preferred. Bachelor’s degree would also be considered in lieu of a clinical licensure/certification.
• Must possess valid IL drivers license and must be deemed as an acceptable driver in accordance with the MHS Fleet Safety Policy (five year MVR will be required). Must have availability of personal vehicle with proof of Insurance.

Experience:

• Five years experience in research, data management or related in a clinical and/or medical record setting required. Oncology research experience preferred.

Other Knowledge/Skills/Abilities:

• Excellent interpersonal skills, self-initiative and self-responsibility.
• Excellent verbal and written communication skills.
• Computer skills to work in research database and access websites containing clinical protocol documents.

1. Screen patients against research protocols and identify those who meet eligibility requirements. Recommend appropriate patients to respective physicians.

2. Educate patients on protocol information, including scheduling needs, testing requirements, etc.

3. Register patients to protocols ensuring eligibility requirements are met.

4. Order all pre-study evaluations per protocol time frames.

5. Attend patient evaluation visits to obtain protocol data. Obtain urine samples when necessary. Abstract and submit protocol data at appropriate intervals.

6. Obtain, review and submit records/materials required for protocol compliance including Pathology, Radiology, Medical Records and Radiation Therapy.

7. Maintain a record keeping system that documents patients registered on research studies, their protocol status, copies of the informed consent and data submitted, and narrative notes.

8. Contact clinical trials subjects to obtain survival information for follow-up trials and report in required format within designated time period.

9. Maintain current files for institutional review board approved studies.

10. Maintain a computerized database of clinical trial enrollments and activities.

11. Complete institutional review board education for compliance with regulatory guidelines.

12. Compile records of institutional review board education and compliance with use of investigational drugs for investigators enrolling subjects in clinical trials.

13. Follow federal, state and local guidelines to maintain compliance for human subject’s protection and reporting clinical trials data.

14. Performs other related work as required or requested.