Sr Research Reg Coord - Cancer Inst
Baltimore-MD-21201-United States
Key Responsibilities:
Regulatory:
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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.
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Ensure all regulatory documentation is in order for study audits and monitoring by National Cooperative Groups (NCGs), pharmaceutical companies, and the FDA.
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Manage the preparation of Informed Patient Consent forms and revisions, ensuring timely IRB submission.
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Oversee documentation for the Administrative Research Review (ARR) and ensure regulatory compliance across clinical trials.
Operations:
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Manage the operational aspects of clinical trial protocols, including the implementation of clinical research agreements, study budgets, and investigator contracts.
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Coordinate pre-study, study initiation, and monitoring visits, working closely with physicians and study sponsors.
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Develop and manage data collection systems, ensuring accurate input and compliance with research group protocols.
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Collaborate with Clinical Research Nurses to collect and submit patient data to NCGs in compliance with protocol standards.
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Maintain and update the list of oncology clinical trials on the LifeBridge Health website and ensure ongoing site compliance.
Professional Development:
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Attend National Cooperative Group meetings and trainings to stay current on regulatory and research guidelines.
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Coordinate investigator and research staff training in Human Research Subjects Protection as per FDA regulations.
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Identify and pursue opportunities for professional growth and development within the clinical research field.
Reports & Quality Assurance:
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Compile and analyze statistical data to generate reports for administration, medical directors, investigators, and various committees.
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Provide statistical and clinical information to external groups supporting ongoing participation in national and local screening programs.
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Develop and maintain protocol reference materials for the medical staff and ensure deadlines for report submissions are met.
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Ensure all work meets the highest standards of quality and efficiency, addressing any potential problems proactively.
Financial Management:
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Manage study finances, including tracking expenditures, preparing clinical research budgets, and ensuring accurate reporting of study financials.
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Work with budget analysts and prepare invoices, ensuring proper coding of payments for finance.
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Ensure accuracy in patient compensation for trial participation and manage monthly financial reports.
Qualifications:
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Education: Bachelor's degree required (Master’s preferred).
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Experience: Minimum of 3-5 years in clinical research regulatory coordination, with significant experience in oncology trials.
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Certifications: Clinical Research Coordinator (CRC) or Clinical Research Associate (CRA) certification is preferred.
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Skills:
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Strong knowledge of IRB processes, regulatory guidelines, and clinical research protocols.
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Excellent communication and organizational skills, with an ability to manage multiple priorities.
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Proficient in database management, data collection systems, and EMR software.
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Understanding of financial management within clinical research settings.
PI276636019
