Summary

Under limited supervision, the Research Program Coordinator role coordinates the RIAO Research Program, including clinical trial regulatory affairs and clinical trial and research data coordination.

Essential Functions include:

Prepares regulatory documents and monitors regulatory activities for assigned clinical trials. Prepares protocol for initial and annual IRB (Institutional Review Board); submits protocol revisions and amendments for IRB review; submits Serious Adverse Events reports and Investigational Drug Safety Reports to the IRB; maintains IRB correspondence documentation for study sponsor and cooperative group audits. Prepares regulatory documentation binders for study monitoring and audits by National Cooperative Groups (NCG)/Pharmaceutical companies/FDA; assists in preparation of patient charts for audits and monitoring visits. Prepares initial Informed Patient Consent forms for study participation; prepares form revisions when requested by study sponsor and submits for IRB review. Manages the day to day regulatory/protocol maintenance operations of the assigned clinical trials. Assists with the implementation of the clinical research agreement, study budget and investigator contract, review and submission; responsible for annual protocol/research agreement renewal coordination. Assists physicians with obtaining protocols of interest; prepares and submits site assessment documentation and regulatory package to study sponsors; coordinates and facilitates pre-study, study initiation and study monitoring visits. Develops data collection system to provide necessary patient and physician communication, report generation and statistical output; manages and augments system as necessary; inputs information into the database and verifies accuracy. Assists Clinical Research Nurses with patient data collection and submits research data to the NCG according to the protocol regulations; assures compliance with standards set by research groups for continued participation

QUALIFICATIONS/REQUIREMENTS

Basic professional knowledge; working knowledge of theory and practice within a specialized field

Education/Knowledge: Preferred- Bachelor's Degree

Health Science/Public Health or related field.

Experience: 1-3 years related exp

Additional Information

Who We Are:

LifeBridge Health is a dynamic, purpose-driven health system redefining care delivery across the mid-Atlantic and beyond, anchored by our mission to “improve the health of people in the communities we serve.” Join us to advance health access, elevate patient experiences, and contribute to a system that values bold ideas and community-centered care.

What We Offer:

Impact: Join a team that values innovation and outcomes, delivering life-saving care to our youngest and most vulnerable patients.

Growth: Opportunities for professional development, including tuition reimbursement and developing foundational skills for neonatal critical care leadership and advanced certification.

Support: A culture of collaboration with resources like unit-based practice councils and advanced clinical education support — improving both workflow efficiency and patient outcomes and allowing you to work at the top of your license.

Benefits: Competitive compensation (additional compensation such as overtime, shift differentials, premium pay, and bonuses may apply depending on job), comprehensive health plans, free parking, and wellness programs.

Why LifeBridge Health?

With over 14,000 employees, 130 care locations, and two million annual patient encounters, we combine strategic growth, innovation, and deep community commitment to deliver exceptional care anchored by five leading centers in the Baltimore region: Sinai Hospital of Baltimore, Grace Medical Center, Northwest Hospital, Carroll Hospital, and Levindale Hebrew Geriatric Center and Hospital.

Our organization thrives on a culture of CARE BRAVELY—where compassion, courage, and urgency drive every decision, empowering teams to shape the future of healthcare.

LifeBridge Health complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, sex or sexual orientation and gender identity/expression. LifeBridge Health does not exclude people or treat them differently because of race, color, national origin, age, disability, sex or sexual orientation and gender identity/expression.