Job Description

Primary Function/General Purpose Of Position

To implement and manage aspects of all active clinical research programs and to assist in other activities as assigned by investigator providers related to these programs with responsibilities to include, but not limited to: interacting with BSHSI legal, finance, compliance, and other departments as appropriate to help start up new clinical trials. Handle consents and agreements, capture patient data and enter it into confidential data management systems provided by industry sponsors, handle regulatory (IRB) submissions for new clinical trials, submit Serious Adverse Event (SAE) information to IRBs, handle amendments, manage safety reports and submit to IRBs as appropriate, track annual review dates and submit continuing reviews, and assist with departmental needs as requested in a back-up capacity.

Requirements And Qualifications

• Bachelor’s degree in a health science, life science, or related field
• Minimum of 2 years of experience in regulatory affairs or clinical research
• Familiarity with regulatory and ethical requirements related to human subjects research (e.g., IRB, FDA, ICH-GCP)
• Strong attention to detail and organizational skills
• Excellent written and verbal communication.
• Ability to manage multiple priorities and meet deadlines
• Critical thinking and problem-solving abilities.
• Proficiency in Microsoft Office and familiarity with regulatory databases

Preferred Requirements And Qualifications

• Master’s degree or regulatory certification (e.g., SOCRA, ACRP)
• Experience working in an academic medical center or large research institution
• Knowledge of electronic regulatory systems and clinical trial management systems (e.g., OnCore, REDCap)

As a Bon Secours Mercy Health associate, you're part of a Mission that matters. We support your well-being—personally and professionally. Our benefits are built to grow with you and meet your unique needs, every step of the way.

What We Offer

• Competitive pay, incentives, referral bonuses and 403(b) with employer contributions (when eligible)
• Medical, dental, vision, prescription coverage, HSA/FSA options, life insurance, mental health resources and discounts
• Paid time off, parental and FMLA leave, short- and long-term disability, backup care for children and elders
• Tuition assistance, professional development and continuing education support

Benefits may vary based on the market and 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 Bon secours Mercy Health – Youngstown, Ohio or Bon Secours – Franklin, Virginia; Petersburg, Virginia; and Emporia, Virginia, which are Affirmative Action and Equal Opportunity Employers, please email ***email_hidden***. 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 ***email_hidden***

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