Project Manager/Research Coordinator 3 (Temporary)

University of Washington•San Diego, CA

23h

About The Position

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.

Requirements

Bachelor’s degree in a related field and four years of relevant experience. Equivalent education and/or experience may substitute for minimum qualifications except when there are legal requirements, such as a license, certification, and/or registration.
Strong interpersonal skills and flexibility to work with personnel at various levels in a cross-institutional research environment.
Demonstrated ability to lead the implementation of complex research protocols and maintain high standards of accuracy, timeliness and professionalism.
Demonstrated ability in ensuring security and confidentiality of study materials.
High level of competency, good judgment, discretion in carrying out tasks, troubleshooting problems and following through on projects to meet deadlines and study benchmarks.
Proven experience demonstrating a high degree of organizational skills with a high degree of attention to details
Proven reliability and flexibility to work independently and function as a lead in directing the work of a diverse team.
Prior experience in a laboratory or clinical research environment to facilitate interactions between laboratory staff, research coordinators and research staff.
Thorough knowledge of HIPAA, IRB and related institutional requirements for the conduct of research.
Experience working with the UW, VA and HMC setting.
Strong verbal and written communication skills.
Ability to commute between various sites: UWMC, NKC, HMC, etc
Basic biostatistical and epidemiological principles/methods, STATA or similar statistical software Certified.
Research Coordinator (CCRC), Association of Clinical Research Professionals.
Research Electronic Data Capture (Redcap) and Bio-repository database experience.
Familiarity and experience with kidney disease and related illnesses.

Nice To Haves

MPH, MS Epi, or related graduate degree.

Responsibilities

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.
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).
Independently prepare and present study updates to investigators, funders, advisory committees, and stakeholders.
Collaborate with the PI to prepare sponsor reports, e.g. RPPR, DSMB.
Oversee the preparation of recruitment reports locally and across sites, with Research Coordinators and others.
Maintain highly organized shared folders, calendars and other information management tools with a high degree of attention to detail.
Provide administrative leadership support for internal study team (e.g., host meetings, draft meeting minutes, and communicate action items).
Serve as primary point of contact for study team and other UW stakeholders.
Develop and maintain external communication and study support materials.
Contribute to KRI-wide communications efforts and external engagement.