At Bon Secours Mercy Health, we are dedicated to continually improving health care quality, safety and cost effectiveness. Our hospitals, care sites and clinicians are recognized for clinical and operational excellence.

Bon Secours

About Us

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.

Job Details

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 within 5 business days of receipt of regulatory packet

• Submit new studies to central/commercialIRBs within 5 business days of receiving finalized ICFs (sponsor & local IRB approval) and approval from Clinical Research Coordinator, unless expedited submission is required or CRO is submitting on site’s behalf.

• Prepare local IRB application in advance with regulatory documents; submit new studies to BSR IRB within 3-5 business days of receipt of commercial IRB initial approval.

Clinical Research Document Management and IRB

• Maintain email archives of all research documents by study, sorting before 90-day expiration

• Maintain regulatory documents using the organizational system provided by Clinical Research Coordinator and/or Practice Administrator (print and file documents on a weekly basis; maintain originals in separate file)

• Archive old studies for Iron Mountain as needed (box up documents & label each box for inventory purposes)

• Organize and maintain research records room on first floor

• Print, obtain required signature(s) and file safety reports within 1 week of receipt.

• Maintain site delegation and training logs

• Forward continuing review notifications to Clinical Research Coordinator and Clinical Research Nurses to complete before submitting

• Maintain site personnel binder; ensure all documents are current, and notify research providers/staff if updates are needed (ie NIH training or license renewals, CV to be signed within 1 year, etc.).

• Assist research nurses with electronic submissions of SAEs if requested

• Forward all requests from monitors for submission of protocol deviations, 1572 modifications, Memos to File, protocol amendments, changes in research/site personnel, and/or requests for SOPs to Clinical Research Coordinator

Data Collection Studies

• Redact PHI from documents electronically and upload for data collection (ie Target studies)

• Assist with items needed for data collection studies for patients on treatment in the practice (ie, PCORI).

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 invoicable items

• Enter patient appointments in Outlook and Athena, make sure the two match, enter case policies

Monitoring Visits / Audits

• Keep an eye on 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

• Drop research charges by noon the next business day

Handle patient calls for patients billed in error and resolve with appropriate contacts by electronic means, for documentation and follow-up purposes (not in-person or by phone); send all SAE related bills to Practice Administrator for reconciliation with sponsor

This position does involve travel in the Richmond area on occasion, and occasional travel to our Hampton Roads clinical research site.

• Additional Job Description

Additional Job Description

Comply with FDA, JCAHO, OSHA, and other regulations and standards.

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

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