Fort Wayne, IN, 46802, USA
10 days ago
Research Project Leader II
Position Summary Parkview Health System is seeking a skilled and experienced Research Project Leader II to join our Health Services and Informatics Research Group. This role is responsible for leading and coordinating multiple research studies simultaneously, ensuring compliance with all regulatory requirements, and maintaining study timelines and deliverables. The ideal candidate will have a strong background in health research, project management, and team leadership. Key Responsibilities + Lead the planning, coordination, and execution of multiple health services and informatics research studies. + Develop study tools such as tracking forms, questionnaires, and source documents. + Oversee subject recruitment, screening, informed consent, training, enrollment, and study close-out. + Independently resolve complex issues and keep project teams aligned with goals and deadlines. + Collaborate with internal and external stakeholders, including clinical staff and community partners. + Ensure full compliance with IRB protocols and all applicable research regulations. + Assist with data collection, validation, and quantitative/qualitative analysis. + Contribute to grant proposals, literature reviews, white papers, presentations, and manuscripts. + Schedule and lead project meetings; monitor progress and ensure milestones are achieved. + Mentor new staff and students, and delegate responsibilities effectively. + Serve as a liaison between participants, research teams, and clinical/community partners. + Represent the research group in system-wide and community-based meetings. Education Requirements + Master’s degree required, or a BSN must be obtained within 3 years of employment (if applicable). + Nurses with ASN hired/rehired before 12/1/17 are grandfathered. + Completion of Parkview General Orientation and research-specific orientation required. + CITI training must be completed within 2 months of hire. Licensure & Certification + ACRP-CP or CAPM certification preferred within one year of hire. + If degree is in nursing, current RN licensure is required. Experience + Minimum 2 years of research experience required. + 3 or more years preferred. Preferred Qualifications + Strong data analysis and information literacy skills. + Knowledge of medical informatics and clinical research processes. + Proficient in Microsoft Office Suite. + Skilled in project timeline management, strategic planning, and staff mentoring. + Familiarity with IRB processes, research ethics, GCP, and human subjects protection. Regulatory Compliance Must remain compliant with the following: + FDA Code of Federal Regulations + HHS regulations + ICH Guidelines + Good Clinical Practice (GCP) standards
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