Job Information
Bon Secours Mercy Health Research Associate (RA) - Bon Secours Liver Institute of VA in Richmond, Virginia
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
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.
Research Associate (RA) - Bon Secours Liver Institute of Richmond
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
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