Research Coordinator

The Research Coordinator will work closely with the Site Principal Investigator to oversee the operational, regulatory, and administrative aspects of the HOPE CKD study. The coordinator will be responsible for ensuring compliance with institutional policies, sponsor requirements, and applicable federal and local regulations, including submission of study materials to the Single Institutional Review Board (University of Pennsylvania), execution of data use agreements, maintenance of regulatory documentation, and adherence to local regulatory requirements.

• Independently manage and oversee research study operations to ensure compliance with study protocols, regulatory requirements, institutional policies, and sponsor expectations.
• Exercise professional judgment in planning, coordinating, and monitoring all phases of study implementation, including participant recruitment, enrollment activities, retention strategies, and study completion.
• Analyze participant eligibility data and collaborate with investigators to facilitate enrollment decisions and recruitment planning.
• Develop, implement, and maintain study tracking systems to monitor enrollment goals, protocol adherence, project milestones, and overall study performance.
• Serve as the operational lead for day-to-day study activities, identifying risks, resolving operational issues, and recommending process improvements to ensure successful study execution.
• Interpret and apply research protocols, sponsor requirements, and regulatory guidelines to ensure compliance across all study activities.
• Oversee study data management activities, ensuring accuracy, completeness, integrity, and compliance with approved research protocols and data governance standards.
• Conduct quality assurance reviews, data validation activities, and protocol compliance assessments; investigate discrepancies and implement corrective actions as appropriate.
• Coordinate participant randomization procedures and ensure proper implementation of study interventions in accordance with protocol requirements.
• Prepare and present study progress reports, enrollment analyses, compliance updates, and operational summaries for investigators, sponsors, and research leadership.
• Maintain oversight of regulatory documentation and essential study records, ensuring readiness for audits, monitoring visits, and regulatory reviews.
• Serve as the primary liaison between the research site, coordinating center, study sponsors, investigators, and other stakeholders, facilitating effective communication and issue resolution.
• Lead study-related meetings, establish project priorities, monitor deliverables, and coordinate follow-up actions necessary to achieve research objectives.
• Collaborate with investigators and research leadership in the development, preparation, and submission of grant applications, competing renewals, progress reports, and sponsored research proposals.
• Gather, analyze, and organize scientific, operational, and financial information required for grant submissions, contracts, and sponsored research activities.
• Coordinate the preparation of supporting documentation, institutional approvals, and required attachments associated with grant and contract proposals.
• Evaluate study resource requirements and provide recommendations to investigators and departmental leadership regarding staffing, operational support, and project needs.
• Partner with departmental administration and principal investigators to monitor project expenditures, budget utilization, and financial performance of sponsored research activities.
• Contribute to the development of scientific abstracts, presentations, manuscripts, and other scholarly products by coordinating research documentation, data reporting, and publication activities.
• Participate in multi-site and collaborative research initiatives, providing subject matter expertise and operational guidance to support study objectives.
• Identify opportunities to enhance study efficiency, participant engagement, data quality, and regulatory compliance through continuous process improvement initiatives.
• Perform other professional research administration and project management responsibilities in support of departmental and organizational goals.

• Bachelor's degree in Public Health, Biological Sciences, Health Sciences, Nursing, Psychology, Social Sciences, or a related scientific discipline.
• Three (3) to five (5) years of progressively responsible experience coordinating or managing clinical research, research administration, or sponsored research programs.
• Demonstrated knowledge of human subjects research, research methodology, regulatory compliance requirements, Good Clinical Practice (GCP), and data management principles.
• Experience interpreting research protocols and exercising independent judgment in coordinating complex research activities.
• Proven ability to manage multiple projects, analyze information, resolve problems, and communicate effectively with investigators, sponsors, regulatory agencies, and research participants.

PI286001417