Senior Clinical Research Coordinator

University of Washington•Seattle, WA

1d•Onsite

About The Position

The Division of Cardiology has an outstanding opportunity for a Senior Clinical Research Coordinator. About this Opportunity Reporting to the Research Manager, this position is responsible for the coordination of human subjects research and clinical trials, requiring in-depth knowledge of protocol requirements and good clinical practice as set forth by federal regulations. The Senior Clinical Research Coordinator will serve as the primary expert for assigned protocols, and will manage study operations and facilitate the daily research activities of the investigators and assigned protocols with an emphasis on the enrollment and follow up of study subjects. This position will be responsible for managing the completion of all data and source documentation including adverse event and safety data. The Senior Clinical Research Coordinator will collaborate to complete IRB submissions and maintain regulatory and compliance files, and source documents. This position will contribute to the development of study budgets, assist with feasibility reviews, and contribute to the development of new processes, procedures, tools, and training to enhance clinical research activities and operations. Position Complexities Reporting to the Clinical Research Manager, this position will utilize operational knowledge of the University of Washington, a firm understanding of the clinical research process, and an ability to integrate this knowledge with research priorities to implement program goals. The Clinical Trials Unit supports a diverse portfolio of clinical research studies with a broad reach of diseases and patient populations, a portfolio of early to late phase clinical trials, and both drug and device interventional studies. Position Dimensions and Impact to the University The CTU provides investigator support on all aspects of heart and vascular disease for investigator initiated, government, and industry sponsored clinical research studies. The CTU supports and manages Human Subjects, regulatory, and financial oversight to ensure efficient execution of studies with the highest quality data.

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.

Nice To Haves

Current certification as a Clinical Research Coordinator or similar through ACRP, SOCRA, or similar accreditation.
Prior experience with interventional clinical trials.
Prior experience working on industry sponsor and FDA regulated clinical trials is preferred.
Experience working on device trials and/or in cardiology is preferred.
Excellent written and verbal communication skills demonstrating diplomatic and tactful professionalism, proven organizational skills and ability to manage multiple complex, high volume projects simultaneously
Demonstrated experience as a self-starter with an ability to work independently, with limited guidance, and in novelty.
Demonstrated problem-solving skills, adaptability, proactiveness, and with a strong emphasis on process improvement.
Experience with training and mentoring new and junior clinical research staff, building collaborative partnerships, and providing effective support and guidance to research support staff and clinical service lines.

Responsibilities

Responsible for all aspects of multiple clinical trials, including patient recruitment and management, and study data collection and management, on a portfolio of complex and high volume projects requiring substantial knowledge of safety reporting requirements, and will be expected to demonstrate a strong ability to enroll into and manage a portfolio of high enrolling clinical trials.
Conduct pre-screening, initial and follow up review activities for study participants, including assessments of subject response to therapy, evaluations of safety events and study assessment data, identification of abnormal values, and assessment and documentation of subject status and protocol compliance.
Maintain oversight and support in the development and implementation of research protocols carried out by various providers within the UW system requiring collaboration with physicians, clinical service line staff, and other research staff.
Responsible for tracking and reporting study invoiceables and activities, reviewing complex procedure billing and invoices for accuracy, and must have a solid understanding of research billing and budgeting compliance processes and requirements.
Serve as protocol and project expert for assigned studies, and serve as a content expert for clinical research operations of assigned study sites, research within clinical indications, Cardiology, and UW clinical service lines.
Implement research protocols, integrating research and clinical requirements to ensure patient safety and protocol compliance.
Communicate research requirements effectively with providers, and clinical service lines involved with patient care.
Oversee the accurate completion and management of all source documents, protocol required documentation, CRF’s, and study, regulatory and compliance documents, including informed consent forms, and submissions to eligibility review boards.
Work independently to obtain, abstract, and code complex clinical information from multiple sources (medical records, research records, etc) for research participants in order to enter data into study specific data capture systems, and to document, assess, and report adverse events to study investigators, sponsors, data safety committees, IRB’s, and other regulatory authorities when applicable.
Work with monitors and sponsors to facilitate study site visits, and under minimal guidance, to develop and implement corrective action plans to ensure protocol adherence and data integrity.
Enter study data on paper or electronic case report forms (eCRF’s) and exercise independent judgement to resolve queries and be able to discern when to escalate issues needing additional intervention or follow up.
Serve as the primary point of contact to communicate with outside physicians and potential patients to provide information on clinical trials and how to refer potential patients.
Reviews clinic census and provider referrals to identify and screen patients for clinical trial eligibility.
Responsible for professional, effective and timely communication with the Industry and sponsor/CRO project offices, core laboratories, clinical sites (NW, UWMC, HMC) and patients is an essential part of this position.
The studies involve enrolling eligible participants in each study, and is expected to facilitate and support complex screening processes, and work with investigators, clinical service lines, and sponsors to meet enrollment metrics and ensure protocol compliance.
Have a good working knowledge of each protocol, solid understanding of UW and clinical processes, clinical trial operations, and a demonstrated ability to independently assess problems and identify solutions.
This position will support, guide, and help train and onboard new and junior research coordinators and other clinical research support staff and clinical service line partners.
This position will assist in the development of new processes, procedures, and tools to enhance clinical research activities and operations.
This position will help develop and establish processes, and support general oversight of quality control assurance on the work of new and junior staff.
This position will utilize knowledge of topics in clinical research, cardiology, UW operations, clinical service lines, and protocols to identify, develop, and implement standardized tools and processes, and to provide feasibility and implementation recommendations for complex and novel clinical research projects.