Project Manager​/Research Coordinator ; Temporary

Position: Project Manager/Research Coordinator 3 (Temporary)
Job Description

The Kidney Research Institute (KRI) has an excellent opportunity for a temporary Project Manager/Research Coordinator 3 to provide expert level lead support for multi-funded and multi-site clinical research studies involving human subjects with kidney disease and related conditions.

This position requires working directly with KRI investigators, KRI staff, and collaborators outside of the University of Washington on a wide range of scientific research projects related to kidney disease. The Kidney Research Institute functions as the research arm within the Nephrology Division of the UW Department of Medicine with a goal of conducting innovative clinical research to improve the health and quality of life of persons with renal disease and related conditions.

The Project Manager will have a vital role in the progression of research at the KRI.

DUTIES AND RESPONSIBILITIES

Project Management:

* Independently coordinate and oversee multiple data collection efforts for multiple complex research projects which may include other collaborating agencies or institutions.

* Oversee and coordinate the transmission of samples and data between collaborators/institutions.

* Develop and prepare annual reports, center reports, grant submission components, JIT materials for principal investigators, industry sponsors and institutional review board to ensure that each project is moving toward timely completion.

* Serve as the primary liaison between the project team and funding agencies or significant parties and for complex regulatory or compliance matters.

* Ensure timely execution of research activities in alignment with project milestones, timelines, and research objectives.

* Implement investigative research protocols and monitor adherence to protocol; troubleshoot and resolve problems such as deviation from protocol requirement.

* Establish, manage, and improve study workflows and quality standards.

* Provide leadership, training, and supervision for research staff as needed.

* Coordinate with KRI managers and other study site personnel for multi-site studies, and coordinate calls/meetings related to studies.

* Lead short- and long-term study planning collaborating with PI and study team to track timelines and progress towards milestones, deliverables and other study tasks).

* Support study team with various research activities as needed.

Manage Regulatory and Start-Up

Activities:

* Provide expert level regulatory and compliance support, and ensure compliance with IRB requirements.

* Lead preparation of human subject applications, consent forms, and modifications in compliance with Institutional Review Board (IRB) requirements.

* Ensure adherence to research protocols and verify accuracy of research study data.

* Responsible for adverse events collection and reporting to IRB, FDA, other fed agencies, sponsors, clinical trials.gov.

* Oversee and ensure compliance with IRB and VA R&D regulations and trainings for all research staff.

* Lead audit preparation and facilitation (internal or sponsor initiated).

* Design/write case report forms - promote consistent data capture and successful statistical analysis; develop research protocols and procedures; develop data dictionaries, merge data sets.

* Contribute to the development of procedures for the design of measurement instruments and scoring systems.

* Authoring technically detailed scientific documentation and study materials appropriate for a general audience and clinical/technical audience.

* Manage all areas of the study start‑up process.

* Collaborate with sponsor/external party to satisfy all site activation requirements.

* Obtain approvals for study-related procedures such as laboratory, imaging, research space, etc.

* Conduct and create process improvement of study protocols and materials.

* Review and resolve complex billing issues; oversee CPT coding accuracy.

* Collaborate with UW Clinical Trials Office (CTO) to develop, negotiate, and finalize budgets and billing procedures.

* Managing studies in OnCore Clinical Trials Management System (CTMS).

Communication and Reporting:

* Independently prepare and present study updates to investigators, funders, advisory…