RESEARCH IMPLEMENTATION MANAGER

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RESEARCH IMPLEMENTATION MANAGER
Req #:
223089
Department:
DEPARTMENT OF MEDICINE: ONCOLOGY
Job Location:
Seattle - Other
Posting Date:
05/30/2023 
Closing Info:
Closes On   06/06/2023
Salary:
$7,083 - $9,167 per month 
Other Compensation:
Shift:
First Shift 
Benefits:
As a UW employee, you will enjoy generous benefits and work/life programs.  For detailed information on Benefits for this position, click here.
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. 


Department of Medicine: Oncology has an outstanding opportunity for Research Implementation Manager.
This position is responsible for clinical trial study start up in the Hematologic Malignancies clinical research program in the Division of Medical Oncology. This position will accelerate clinical trial study start up by developing and optimizing new and ongoing study start-up processes. This position works with minimal supervision and negotiates optimal pricing and payment terms with sponsors; coordinating the submission of a wide range of study start-up documents including pricing requests to various UW, SCCA, and FHCRC departments, developing study budgets, negotiating study budgets. This position requires the ability to understand clinical research coordination, revenue cycle development, budgeting, compliance, and regulations.


Medical Oncology is a Division within the Department of Medicine.  The Divisions primary mission is to improve cancer care by moving discoveries made in the laboratory to a clinical setting and finding new and innovative ways to use existing therapies.  Our vision is to be national leaders in oncology translational medicine.


The Division of Medical Oncology is primarily located in the Seattle Cancer Care Alliance (SCCA), on the Fred Hutchinson Cancer Research Center campus, but also has faculty and staff located at **MEMBERS ONLY**SIGN UP NOW***. (UW) Medical Center, Harborview Medical Center, the VA Puget Sound Health Care System, and South Lake Union.  This position interacts closely with multiple process partners, including SCCA, UW, and FHCRC clinical and administrative departments, and multiple regulatory committees.


The research projects managed by this position are complex. This position requires the ability to integrate information from multiple sources to ensure that all research proposals meet the requirements of the University, the Food and Drug Administration, the National Institutes of Health, and the study sponsor. This position is required to use independent judgment and knowledge of the academic clinical trial business to effectively facilitate the workflow and promote a collaborative work environment.


The position will maintain dynamic communication with the study investigators, research staff, University departments, SCCA departments, and the FHCRC departments, other development partners. There are multiple resources available within the University system to help in this process, but ultimately, the work must be done with limited assistance and in a resourceful manner to expedite opening a clinical trial. This position interacts with representatives from pharmaceutical companies, health care providers and colleagues in a manner that well-represents the **MEMBERS ONLY**SIGN UP NOW***..


The mission statement of the **MEMBERS ONLY**SIGN UP NOW***. 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 is key to the success of the Hematologic Malignancies Clinical Research Program as timely study start-up is of direct benefit to those we serve. This position will require a strong partnership with faculty and staff within and external to the programs.


This position must be able to work independently on multiple research projects with minimal written policies or procedures.  This position requires daily interaction with pharmaceutical sponsors, physicians, Hematologic Malignancies team members, and other partners. Up to 10 projects will be in progress simultaneously, with the expectation of additional projects in the future.


RESPONSIBILITIES:
Manage clinical trial start-up processes (85%)
Establish and maintain methods to initiate study start-up budget planning.

Use knowledge of clinical research, medical terminology, and clinical processes to translate complex oncology protocol requirements into clinical trial budgets and facilitate submissions to relevant compliance offices.

Forecast, track and report study start-up timelines.

Prepare and submit eGC1s in accordance with OSP requirements and deadlines

Ensure SFI compliance is completed and required approvals are received by OSP deadlines

Create Advanced Budget Numbers

Independently negotiate successful clinical trial budgets and payment terms with study sponsors.

Coordinate and communicate with UW and SCCA offices involved in the review and negotiation of clinical trial budgets and contracts, including UW Clinical Research Budget and Billing office, the UW Office of Sponsored Programs, and the Seattle Cancer Care Alliance Clinical Operations-Research Services

Guide regulatory staff for timing of necessary submissions (Scientific Review Committee, UW Human Subjects Division, Radiation Safety, FDA submissions, and IRB submissions), in order to meet projected start-up deadlines

Assist Hematologic Malignancies Managers with developing start-up tools and metrics

Develop and track study start-up pieces and report progress to Hematologic Malignancies Managers, faculty, and study team members.

Communicate with Hematologic Malignancies Research Coordinators and fiscal staff budget billing designations to ensure billing compliance.


Budget and Contract Amendments (15%)
Process budget and contract amendments.

Independently negotiate successful clinical trial budget amendments and payment terms with study sponsors.

Create new eGC1s, if required, in accordance with OSP policies.


Perform other duties as assigned.


MINIMUM REQUIREMENTS:
Bachelor's degree in business, science or health-related field

Minimum of three years-experience with budget development, clinical research coordination, or related project management or health care experience


Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.
ADDITIONAL REQUIREMENTS:
Ability to work effectively and efficiently in a group environment

Exceptional organizational and customer service skills

Strong written and oral presentation skills

Ability to communicate effectively with all levels of faculty, management and clinical research staff

Ability to convey complex policy, financial and scientific/technical information in a manner that is understandable to a wide audience

Ability to teach and mentor others in group settings, in one-on-one sessions, and remotely

Ability to prioritize and organize work independently

Demonstrated skill in using Microsoft Office Suite

Applicants selected for this position who have not already completed the training for clinical research involving human subjects will be required to complete it within 90 days of hire.


DESIRED:
Experience in an academic medical center

Experience as a research study coordinator

Experience in oncology clinical research

Familiarity with interpreting regulatory and contractual documents, identifying and resolving ambiguities, negotiating pricing and payment terms, and interpreting complex implications of research protocols.

Knowledge of the Medicare Clinical Trials Policy and other federal, state and institutional clinical research regulation

Strong working knowledge Microsoft Office Suite.

Experience with the Study Review and Management Portal (sRAMP)


WORKING CONDITIONS:
Fast-paced office environment, with a high volume of often-complex projects. The work is deadline driven and requires rapid and frequent communications, not only between individuals, but also by computer and/or telephone for much of the day. Projects may require travel between affiliate locations to facilitate budgeting communication. Work week regularly exceeds 40 hours per week.

The position is located in a clinical and research environment that is located at the Seattle Cancer Care Alliance on the Fred Hutchinson Cancer Research Center. Travel to/from campus buildings is required.

Position requires the ability to lift study binders and materials as needed as they may be stored away from immediate desk.

This position requires a flexible work schedule. Stringent deadlines from sponsor organizations/companies to meet deadlines may require overtime including occasional evening and weekend overtime.




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 Work 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.
Committed to attracting and retaining a diverse staff, the **MEMBERS ONLY**SIGN UP NOW***. 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.
The **MEMBERS ONLY**SIGN UP NOW***. 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, **** 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
COVID-19 VACCINATION REQUIREMENT
Employees of the **MEMBERS ONLY**SIGN UP NOW***. are required to be fully vaccinated against COVID-19 unless a medical or religious exemption is approved. Being fully vaccinated means that an individual is at least two weeks past their final dose of an authorized COVID-19 vaccine regimen. As a condition of employment, newly hired employees will be required to provide proof of their COVID-19 vaccination. View the Final candidate guide to COVID-19 vaccination requirement webpage
for information about the medical or religious exemption process for final candidates.
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Categories
Healthcare
Management
Customer Service
Biotechnology / Science
Administrative / Clerical
Posted:
2023-06-01
Expires:
2023-07-01
**MEMBERS ONLY**SIGN UP NOW***.

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