Senior Clinical Research Coordinator

Job Description

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 andvasculardiseasefor investigator initiated government and industrysponsoredclinicalresearch studies. The CTU supports and manages Human Subjectsregulatory and financial oversight to ensure efficient execution of studies with the highest quality data.

DUTIES AND RESPONSIBILITIES

Project Management (50%)

• 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.
• Ability and comfort with working at a high level independently consistently and accurately and in compliance with GCP and federal and state regulations and to follow research protocols is an expectation of this position. This position requires demonstrated ability to multitask and manage multiple high complexity projects have a strong attention to detail and exceptional communication skills with peers investigators clinic staff sponsors patients and other collaborators and stakeholders.
• Effectively work in a collaborative manner with research team members clinical service lines sponsors and other partners to ensure that projects are executed successfully study recruitment goals are met and projects and processes are implemented and executed successfully and completely within the required timeframes to meet research objectives.

Study Data Collection and Patient Management (30%)

• 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 CRFs 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 IRBs 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 (eCRFs) 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.

Administration and Communication Management (15%)

• 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.

Additional Duties (5%)

• This position will be expected to demonstrate substantial competency as a Research Coordinator and ability to perform tasks independently consistently and accurately and demonstrate a high level of expertise to apply skills and abilities to support the coordination of complex high volume clinical trials.
• 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.

MINIMUM REQUIREMENTS

• Bachelors 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.

DESIRED QUALIFICATIONS

• 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.

CONDITIONS OF EMPLOYMENT

• On-site work across multiple sites in and around Seattle WA is expected with occasional telework permitted. This position will be responsible for implementing and coordinating a portfolio of clinical trials across several sites with UW-Northwest being the primary research base and UW-Montlake and Harborview being additional work sites.

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Compensation Benefits and Position Details

Pay Range Minimum:

Pay Range Maximum:

Other Compensation:

Benefits:

Temporary or Regular

FTE (Full-Time Equivalent):

Union/Bargaining Unit:

About the UW

Working at the University of Washington provides a unique opportunity to change lives on our campuses in our state and around the world.

UW employees bring their boundless energy creative problem-solving skills and dedication to building stronger minds and a healthier return they enjoy outstanding benefits opportunities for professional growth and the chance to work in an environment known for its diversity intellectual excitement artistic pursuits and natural beauty.

Our Commitment

The University of Washington is committed to fostering an inclusive respectful and welcoming community for all. As an equal opportunity employer the University considers applicants for employment without regard to race color creed religion national origin citizenship sex pregnancy age marital status sexual orientation gender identity or expression genetic information disability or veteran status consistent with UW Executive Order No. 81.

To request disability accommodation in the application process contact the Disability Services Office at or .

Applicants considered for this position will be required to disclose if they are the subject of any substantiated findings or current investigations related to sexual misconduct at their current employment and past employment. Disclosure is required under Washington state law.