Clinical Research Assistant - Cra - Clinical Trial-Oncology

Thank you for considering a career at Bon Secours!
Bon Secours
As a faith-based and patient-focused organization, Bon Secours exists to enhance the health and well-being of all people in mind, body, and spirit through exceptional patient care. Success in this goal requires a culture of compassion, collaboration, excellence, and respect. Bon Secours seeks people that are committed to our values of compassion, human dignity, integrity, service, and stewardship to create an environment where associates want to work and help communities thrive.
Clinical Research Assistant - Clinical Trial-Oncology - St. Francis - Midlothian
Summary of Primary Function/General Purpose of Position:
Support Clinical Research team of Bon Secours Liver Institute of Virginia (PI/Sub-Inv/nurses/coordinators, etc.) in financial and administrative tasks needed to ensure the entire research operation functions properly with guidance and direction from Clinical Research Nurse Coordinators and/or Practice Administrator, with oversight from Principal Investigator. This position primarily supports Bon Secours Liver Institute of Richmond.
Essential Functions:
Epic
Assist Clinical Research nurses in enrolling patients in research studies, associating visits/ appointments/ admissions with research studies (utilizing both reporting workbench report and within the patient chart), and reviewing charges via the Research Billing Report to determine which are billed to Insurance and which are billed to the research study.
New Study Start-Up

• Submit all regulatory documents for new studies
• Submit new studies to central/commercial IRBs
• Prepare local IRB application in advance with regulatory documents; submit new studies to BSMH IRB for acknowledgement
• Complete BSMH Financial Disclosure/Conflict of Interest forms

Financial

• Handle patient calls for patients billed in error and resolve with appropriate contacts by electronic means, for documentation and follow-up purposes.
• Gather SAE-related bills for reimbursement by sponsor.
• Update invoiceable items log for participants enrolled in multiple ongoing clinical trials.
• Assist with journal entry requests for BSMH lab, pharmacy, pathology, and other services for participants enrolled in Clinical Research trials.
• Assist the research nurse coordinators with the research billing work queue in Epic
• Utilize Clinical Trials Management System (CTMS) (i.e., SignalPath) to assist with invoicing

Clinical Research Document Management and IRB

• Maintain archives of all correspondence and documents related to clinical trials electronically.
• Set up and maintain regulatory binders for each clinical trial.
• Archive closed study documents for storage off-site (i.e., Iron Mountain).
• Manage safety reports for each clinical trial.
• Maintain site delegation and training logs for each clinical trial; update site contact documentation and federal 1572s with IRBs, CROs, and sponsors for site personnel changes.
• Collect W9 forms and save electronically. Assist BSMH Accounting with 1099s as needed.
• Maintain site credentialing binder; ensure all documents are current, and notify research providers/associates if updates are needed (i.e. GCP training or license renewals, CVs) and update as personnel changes
• Assist research nurses with electronic submissions of SAEs as needed

Education:

• High School Degree or GED

Data Collection Studies

• Redact PHI from documents electronically and upload for data collection
• Assist with items needed for data collection / observational studies.

Patient registration, linking, and scheduling

• Upon notification from Clinical Research Nurses, register and link each patient to their research study in ConnectCare upon screening and/or enrollment
• Assist research nurses with the work queue in ConnectCare as needed
• Utilize ConnectCare to update invoiceable items
• Enter patient appointments Epic; link to research and ensure charges drop to research in accordance with contracts.

Monitoring Visits / Audits

• Utilize Outlook calendar, be aware of upcoming monitoring visits, and prepare in advance with regulatory documents filed in regulatory binder(s) for the study, and available for review.
• Assist in preparing for internal or other audits, including FDA.

Other Clinical Research activities
Other tasks assigned by Clinical Research Coordinators/Navigators, Clinical Research Nurses, Practice Administrator and Principal Investigator.
Bon Secours is an equal opportunity employer.
Many of our opportunities reward* your hard work with:

• Comprehensive, affordable medical, dental and vision plans
• Prescription drug coverage
• Flexible spending accounts
• Life insurance w/AD&D
• Employer contributions to retirement savings plan when eligible
• Paid time off
• Educational Assistance
• And much more

*Benefits offerings vary according to employment status
Scheduled Weekly Hours:
40
Work Shift:
Days (United States of America)
Department:
Clinical Research Richmond Oncology
All applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, sexual orientation, gender identity, age, genetic information, or protected veteran status, and will not be discriminated against on the basis of disability. If you'd like to view a copy of the affirmative action plan or policy statement for Mercy Health - Youngstown, Ohio or Bon Secours - Franklin, Virginia; Petersburg, Virginia; and Emporia, Virginia, which are Affirmative Action and Equal Opportunity Employers, please email recruitment@mercy.com. If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact The Talent Acquisition Team at recruitment@mercy.com.