POSITION PURPOSE

The Clinical Research Assistant works in collaboration with Clinical Research Coordinators and clinical research operations team to manage data collection, entry, submission and related queries, as well as general trial administrative oversight for all studies.

The Clinical Research Assistant works under the general supervision of the Clinical Research Coordinators and Supervisor of Clinical Research Operations.

ESSENTIAL FUNCTIONS

1. Create and modify eligibility, screening, and cycle visit flow sheets for all recruiting studies.

2. Request and send tissue, most importantly follow up with the hospitals and central lab regarding the result

3. Prepare patient binders for all newly enrolled patients (i.e. dividers, binder cover, etc.).

4. Prepare lab kits for all patients scheduled one day in advance.

5. Manage lab kit inventory and inventory of other trial supplies take initiative on following up with outstanding issues with outside entities.

6. Request and ensure that medical records are received and filed in patient chart. Follow up with medical records department of the hospital if not received

7. Assist to maintain and organize patient binders in preparation for monitor visits. File applicable patient documents in the appropriate binders.

8. Burn and mail out radiology scans to applicable parties per protocol requirements. Also ensure to transfer images into patient charts.

9. Enter data collected within 3-5 business days from date of visit for all studies and resolve queries within 48 hours. Also, make data corrections as required and requested by monitors.

10. Conduct EKGs for studies.

11. Assist in creating and modifying care plans for all research trials. Assist to collect and record data necessary for enrollment and study activity.

12. Manage data collection via chart abstraction and submit data in a timely fashion to required sources. This includes data collection for Medical History Log and the ConMed Logs.

13. Responsible for a detailed understanding of protocol schedule of events.

14. Prioritize tasks based on level of urgency, data lock timelines and scheduled visits. Work closely with CRCs to ensure that the tasks listed above have been completed in preparation for monitoring visits and/or patient visits.

15. Follow up on all tasks that have been assigned above to ensure that they are completed in a timely fashion. Take the lead on following up with and escalating matters that are outstanding and ask for assistance from the rest of the research team when needed.

EDUCATION CERTIFICATION

Certified Clinical Research Professional (CCRP) and Certified IRB Professional (CIP) preferred.

EXPERIENCE

Prior regulatory experience at institution –based or free standing cancer center with exposure to oncology clinical research program preferred.

REQUIREMENTS

High School diploma or some college degree certificate or diploma

Current Medical Assistant Certification/CPT1 or Bachelor’s degree in related field (science, healthcare, nursing).

Current CPR Certification

Strong interpersonal, organizational and communication skills are required