Clinical Research Assistant - Clinical Trial-Oncology - St Francis - Midlothian

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Scheduled Weekly Hours:

Work Shift:

Bon Secours

As a faithbased and patientfocused organization Bon Secours exists to enhance the health and wellbeing 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 TrialOncology St. Francis Midlothian

Summary of Primary Function/General Purpose of Position:

Support clinical research team of Bon Secours Liver Institute of Virginia (PI/SubInv/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 StartUp

• Submit all regulatory documents for new studies
• Submit new studies tocentral/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 followup purposes.
• Gather SAErelated 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 offsite (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 MercyHealth 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.

Department:

It is our policy to abide by all Federal and State laws as well as the requirements of 41 CFR 601.4(a) 60300.5(a) and 60741.5(a). Accordingly 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 youd 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 Employer please email . 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 .