Clinical Research Manager

Job Description

CLINICAL RESEARCH MANAGER

Req #: 188424 Department: RHEUMATOLOGY Job Location: Harborview Medical Center, Seattle Campus, South Lake Union, UW Medical Center - Northwest Posting Date: 03/19/2021 Closing Info: Open Until Filled Salary: Salary is commensurate with education and experience Shift: First Shift Notes: The University of Washington is following physical distancing directives from state and local governments as part of the collective effort to combat the spread of COVID-19. Click here for updates
“Onsite work” in the interim will vary for units and for specific positions and will be discussed with candidates during the interview process. As a UW employee, you have a unique opportunity to change lives on our campuses, in our state and around the world. UW employees offer their boundless energy, creative problem solving skills and dedication to build stronger minds and a healthier world.
UW faculty and staff also enjoy outstanding benefits, professional growth opportunities and unique resources in an environment noted for diversity, intellectual excitement, artistic pursuits and natural beauty.
Position Purpose:
The University of Washington, Division of Rheumatology has an excellent position for a Clinical Research Manager (CRM) in the Clinical Trials Research Unit.
The purpose of this position is to promote the clinical research objectives of the in the Division of Rheumatology. This position works with Division of Rheumatology faculty to facilitate pharmaceutical-sponsored and investigator-initiated clinical trials.
Position Complexities:
This position is responsible for independently implementing multiple clinical research projects to test the hypotheses in human subjects and facilitate correlative work.
This position is constantly required to integrate information from multiple sources to ensure that all research proposals meet the requirements of the University, FDA, NIH, and the study sponsors.
This position develops procedures that ensure that all research meets or exceeds these requirements while expeditiously furthering the research objectives of the Rheumatology research units. There are multiple resources available within the University system (e.g. Grant & Contract Accounting, Institutional Review Board, Clinical Research Budget & Billing, Office of Sponsored Programs) to help in this process, but ultimately, the work must be done independently and in the resourceful manner to expedite the Division's research objectives.
The Clinical Research Manager will work with the research team to collect and abstract clinical data from medical records and research charts, work closely with the physicians and research staff in providing administrative and technical support for research projects, and will follow complex instructions for processing laboratory samples (including blood, urine, and tissue samples) for tracking, storage, or shipping.
In addition, the CRM will participate in pharmaceutical meetings to determine UW eligibility for upcoming clinical trials. In this capacity, the CRM will represent the Division, providing potential sponsors with the necessary information to determine site selection and funding.
Position Dimensions and Impact to the University:
The mission statement of the University of Washington Medical Center states that the Medical Center serves as a research resource, providing an environment in which clinical research may be conducted. This position is essential to that mission. This position provides significant contributions to research development, implementation and analysis for the Division of Rheumatology. It is responsible for overseeing the management of clinical trials, the Division's clinical data collection, the Division's regulatory compliance with work with human subjects. Furthermore, at any one time this position will support up to 10 active research protocols.
Position Responsibilities:
This position must be able to work independently on multiple research projects without benefit of written policies or procedures. This position requires daily interaction with physicians, other health care personnel (e.g. nurses, patient care coordinators, patient service representatives, medical assistants), pharmaceutical company sponsors and any other groups integral to the successful completion of the research project.
Research Patent Management

Create and manage patient study records, including management of study binders, source documentation, and incoming paperwork. This includes generation, completion, and review of patient specific documentation.

Communicate as needed with external patents and external physicians who are interested in referring patients to UWMC for Rheumatology clinical trials.

Manage complex study appointments, ordering tests & procedures to facilitate protocol adherence, billing compliance, and ensure accurate and reliable data collection. Participate in consenting of patients with providers and independently depending on protocol requirements. Escort patients to study appointments. Educate patents about trial requirements and visit schedule. Conduct telephone and face to face interviews with patients to collect research data per protocol.

Understand clinical trial budget and billing plan for patients enrolled on clinical trials. Work with internal partners to ensure clinical trials are performed in accordance with institutional requirements for billing compliance. Assist in financial audits as necessary.

Communicate with investigators and staff when financial milestones have been met.

Collate and maintain clinical information from multiple sources into research charts, study binders, etc.

Independently track and maintain research subject schedules based on complex protocol-specific requirements.

Assist with retrieval and return of oral investigational agents to IDS pharmacy.

Review patient records to identify eligible participants

Manage patient referrals and recruiting for clinical trials
Research Operations Management

Responsible for budget development for Sponsor and investigator-initiated studies

Works with investigators to ensure clinical research budgets are financially sound, accurate, and compliant

Conducts budget negotiation with Industry sponsors for clinical trials

Work with investigators to develop and modify research proposals, and protocol feasibility based on funding constraints

Serve as single point of contact and responsible person external partners in budget and regulatory reporting.

Responsible for strategic development to increase research participation, meet recruitment goals, and provides collaboration to elevate the research profile within the Division.

Developed and co-edit the UW Research in Rheumatology newsletter to improve patient engagement and make UW’s contribution to scientific advancement more accessible to the public.
Protocol Management and Regulatory Compliance

Design, create, complete, and revise research instruments (case & control consent forms) as necessary to ensure quality data that correlates with research objectives.

Understand and ensure compliance with all IRB Protocols within the Division (currently seven active IRB Approved Protocols)

Support all research faculty and fellows in the Division with IRB compliance. This includes annual renewals, new protocols, modifications, and study closeout.

Write and manage IRB protocols

Developed and manage the umbrella Rheumatic Disease Biorepository IRB to improve and simplify compliance for translational researchers

Provide consult services to investigators to support protocol and research proposal development

Collaborate with investigators to write investigator-initiated protocols

Serve as a sub- investigator on 1572 FDA agreements

Produce and manage submissions to the FDA for Investigational New Drugs (IND) and IND waivers
Data Coordination, Abstraction and Analysis

Work independently to obtain, abstract, and code complex clinical information from multiple sources (medical records, research records, etc.) for research subjects. Code and record said information into various study-specific data-capture systems (both electronic and paper-based).

Resolve and answer data queries with minimal errors.

Make independent judgments about the relevance of the clinical data to the research for complicated auto-immune research subjects.

Principally responsible for maintaining computer spreadsheets and databases for research studies.

Understanding research study flow, work with clinic staff support services and research team members to set-up research subject appointments at required intervals.

With study team, draft scheduling request orders to meet study protocol needs.

Independently develop study-specific or program data acquisition forms.

Work professionally with sponsor representatives to review and correct data recorded in the case report forms. Exercise independent judgment on query resolutions.

Work with Principal Investigator to consent patients for open research studies.

Create and manage data capture tools to support investigator-initiated research projects
Clinical Trial Management System (CTMS) Data Entry

Enter completed patient visits, protocol deviations and additional data points into CTMS system.

Collaborate with members of research team to ensure data entry is up to date and accurately reflects activities relating to research.

Develop CTMS files for individual studies

Manage Sponsor and internal/external partner PAYEE invoicing and payment tracking for services

Manage and track Sponsor and internal/external partner PAYER invoicing and payment tracking for services
Research Specimen Tracking and Coordination

Independently maintain and track laboratory sample supplies, complete requisition forms, and
assemble kits for upcoming research subject visits for assigned clinical trials.

Independently track and process research subject blood, urine, and tissue samples following study
specific guidelines for storage and/or shipping.

Assist Investigators and study team with preparation and analysis of study data for publication and grant preparation.

Provide oversight, guidance, and management of Biorepository specimen collection and banking

Serve as PI Proxy/Gatekeeper to review specimen/data requests from the Biorepository

Serve as PI Proxy/Gatekeeper to approve specimen/data requests from the Biorepository
Research Billing

Assist Administrator in insuring proper billing of research charges.

Responsible for all aspects of ensuring proper billing of research charges

Additional duties as deemed qualified
As a UW employee, you will enjoy generous benefits and work/life programs. For a complete description of our benefits for this position, please visit our website, click here.
REQUIREMENTS

Bachelor’s degree in sciences, public health, or related discipline and two years of related experience.
Additional Requirements:

Demonstrated understanding of medical terminology

Strong computer skills and experience with data entry and databases

Strong attention to detail and ability to organize work

Ability to communicate effectively both verbally and in writing, and to work effectively with colleagues, research subjects, and study sponsor representatives

Demonstrated ability to work independently and to carry out complex tasks
Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.
DESIRED

Knowledge of Rheumatology practice and terminology

Prior experience in basic processing laboratory samples

Competency in Microsoft Office software

Competency in Allegro CTMS software

Knowledge of HIPAA regulations

Knowledge of GCP (Good Clinical Practice)
CONDITIONS OF EMPLOYMENT
Application Process:
The application process for UW positions may include completion of a variety of online assessments to obtain additional information that will be used in the evaluation process. These assessments may include Workforce Authorization, Cover Letter and/or others. Any assessments that you need to complete will appear on your screen as soon as you select “Apply to this position”. Once you begin an assessment, it must be completed at that time; if you do not complete the assessment you will be prompted to do so the next time you access your “My Jobs” page. If you select to take it later, it will appear on your "My Jobs" page to take when you are ready. Please note that your application will not be reviewed, and you will not be considered for this position until all required assessments have been completed.

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 .

Committed to attracting and retaining a diverse staff, the University of Washington will honor your experiences, perspectives and unique identity. Together, our community strives to create and maintain working and learning environments that are inclusive, equitable and welcoming.

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The University of Washington is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, national origin, age, protected veteran or disabled status, or genetic information.

To request disability accommodation in the application process, contact the Disability Services Office at 206-543-6450 or [email protected] .

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