Summary

Key Responsibilities:

Regulatory:

Prepare and submit regulatory documents for initial and annual IRB review (local and central), including protocol revisions, amendments, Serious Adverse Event (SAE) reports, and Investigational Drug Safety Reports.

Ensure all regulatory documentation is in order for study audits and monitoring by National Cooperative Groups (NCGs), pharmaceutical companies, and the FDA.

Manage the preparation of Informed Patient Consent forms and revisions, ensuring timely IRB submission.

Oversee documentation for the Administrative Research Review (ARR) and ensure regulatory compliance across clinical trials.

Operations:

Manage the operational aspects of clinical trial protocols, including the implementation of clinical research agreements, study budgets, and investigator contracts.

Coordinate pre-study, study initiation, and monitoring visits, working closely with physicians and study sponsors.

Develop and manage data collection systems, ensuring accurate input and compliance with research group protocols.

Collaborate with Clinical Research Nurses to collect and submit patient data to NCGs in compliance with protocol standards.

Maintain and update the list of oncology clinical trials on the LifeBridge Health website and ensure ongoing site compliance.

Professional Development:

Attend National Cooperative Group meetings and trainings to stay current on regulatory and research guidelines.

Coordinate investigator and research staff training in Human Research Subjects Protection as per FDA regulations.

Identify and pursue opportunities for professional growth and development within the clinical research field.

Reports & Quality Assurance:

Compile and analyze statistical data to generate reports for administration, medical directors, investigators, and various committees.

Provide statistical and clinical information to external groups supporting ongoing participation in national and local screening programs.

Develop and maintain protocol reference materials for the medical staff and ensure deadlines for report submissions are met.

Ensure all work meets the highest standards of quality and efficiency, addressing any potential problems proactively.

Financial Management:

Manage study finances, including tracking expenditures, preparing clinical research budgets, and ensuring accurate reporting of study financials.

Work with budget analysts and prepare invoices, ensuring proper coding of payments for finance.

Ensure accuracy in patient compensation for trial participation and manage monthly financial reports.

Qualifications:

Education: Bachelor's degree required (Master’s preferred).

Experience: Minimum of 3-5 years in clinical research regulatory coordination, with significant experience in oncology trials.

Certifications: Clinical Research Coordinator (CRC) or Clinical Research Associate (CRA) certification is preferred.

Skills:

Strong knowledge of IRB processes, regulatory guidelines, and clinical research protocols.

Excellent communication and organizational skills, with an ability to manage multiple priorities.

Proficient in database management, data collection systems, and EMR software.

Understanding of financial management within clinical research settings.

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.