Research Associate

Case Western Reserve University•Cleveland, OH

3d•Onsite

About The Position

Working under the general direction of the Principal Investigator (PI), the Research Associate serves as the project manager for an NIH-funded clinical research study and coordinates the day-to-day operational, scientific, and regulatory activities of the project. The incumbent collaborates closely with the PI to ensure the successful implementation of study protocols, participant recruitment and retention, regulatory compliance, personnel coordination, data quality, and study operations. The Research Associate provides operational leadership for the project and supports the Principal Investigator with administrative oversight and day to day management of the research program. As the project matures and operational needs evolve, the incumbent may assume increasing responsibility for selected administrative and project management functions under the Principal Investigator's direction.

Requirements

Demonstrated knowledge of federally funded clinical research operations, including human subjects, research regulations, Good Clinical Practice (GCP), Institutional Review Board requirements, and NIH-sponsored research protocols.
Willingness to learn and work with artificial intelligence (AI) tools and technologies.
Demonstrated ability to collaborate effectively with multidisciplinary research teams while supporting the educational mission of the FPB School of Nursing.
Ability to coordinate multiple concurrent research activities while exercising sound judgment, maintaining attention to detail, and meeting competing deadlines in a fast-paced clinical environment.
Ability to meet consistent attendance.
Strong organizational, analytical, and project management skills with the ability to coordinate study operations, monitor progress toward project milestones, and identify operational issues requiring resolution.
Ability to interact with colleagues, supervisors, and customers face-to-face. Demonstrated ability to communicate professionally and effectively both verbally and in writing with faculty investigators, research staff, students, healthcare professionals, study participants, and external collaborators.
Ability to establish and maintain effective working relationships while providing day-to-day operational guidance, training, mentoring, and workflow coordination for research personnel under the direction of the Principal Investigator.
Working knowledge of research data management systems and research technologies, including REDCap, Epic, Microsoft Office Suite, ClinicalTrials.gov, and other electronic research management systems.
Ability to interpret and apply University, sponsor, hospital, IRB, HIPAA, and federal regulatory policies and procedures governing human subjects research.
Demonstrated ability to maintain confidentiality and exercise discretion when handling protected health information (PHI), research data, personnel information, and other sensitive materials.
Ability to prepare, review, and maintain regulatory documentation, research reports, grant-related documentation, and study records with a high degree of accuracy and attention to detail.
Commitment to professionalism, collaboration, continuous improvement, and ethical conduct in support of the FPB School of Nursing, the mission of CWRU, sponsored research activities, and applicable institutional policies.

Nice To Haves

Experience coordinating federally funded clinical research, human subjects protection, regulatory compliance, participant recruitment, and research operations is preferred.
Demonstrated experience with IRB processes, REDCap, ClinicalTrials.gov, NIH reporting requirements, Good Clinical Practice (GCP), CITI certification, and research protocol implementation is preferred.
Experience coordinating research personnel or student employees is preferred.

Responsibilities

Coordinate the day-to-day operational activities of the NIH-funded clinical trial. Collaborate with the Principal Investigator to ensure study activities are conducted in accordance with the approved IRB protocol, NIH Notice of Award, sponsor requirements, and applicable university and hospital policies. Coordinate participant recruitment, enrollment, retention, intervention delivery, longitudinal follow-up, and data collection activities while identifying and assisting in the resolution of operational barriers affecting study implementation (25%)
Coordinate regulatory and compliance activities for the research study, including preparation and submission of IRB applications, amendments, continuing reviews, reportable events, and maintenance of regulatory documentation. Maintain NIH regulatory binders, monitor personnel training requirements (including CITI and Good Clinical Practice), coordinate ClinicalTrials.gov reporting, prepare monthly CROMS reports, and support development and maintenance of study standard operating procedures. (22%)
Assist the Principal Investigator with recruitment, interviewing, onboarding, orientation, training, supervision, scheduling and performance feedback for research personnel, graduate assistants and student employees. Provide day-to-day work direction and operational support to research staff while the Principal Investigator retains final authority over personnel actions and employment decisions. As operational responsibilities expand, the Research Associate may assume additional leadership responsibilities as delegated by the Principal Investigator (22%)
Monitor grant expenditures, assist with budget tracking, purchase coordination, inventory management, fiscal projections, and project planning. Collaborate with the Principal Investigator and School finance staff to support responsible stewardship of grant resources. Final approval authority for budgetary and purchasing decisions remains with the Principal Investigator and the School’s administrative and finance offices. (15%)
Prepare and contribute to NIH progress reports, regulatory reports, manuscripts, presentations, and grant-related documentation. Collaborate with the Principal Investigator and research team to support publication efforts, dissemination of research findings, and development of future grant proposals and externally funded research initiatives. (11%)
Maintain required research credentials and currency. Maintain CITI human-subjects certification, Good Clinical Practice training, and University Hospitals credentialing as required, and stay current with applicable University, IRB, and sponsor policies. (3%)
Perform other duties as assigned. (2%)