Clinical Research Manager

University of Washington Shoreline, WA
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The Department of Radiation Oncology has an outstanding opportunity for a full-time Clinical Research Manager. The purpose of this position to manage and operate the Radiation Oncology Clinical Research Program. This position reports to the Clinical Science Director also known as the Director, Administration and Finance. Functional areas include oversight of the process of clinical trial protocol development (faculty will write the protocols), study start up, protocol implementation, data analysis and study close out, as well as research staff supervision. Clinical research studies in the department include cooperative group trials, investigator-initiated and collaboration with industry-initiated protocols.

The Research Manager will also assist with the following: in collaboration with the Director, implement initiatives in support of the Department's strategic plan; identify problems with clinical trial start-up and management; assist with organized improvement efforts; and use problem solving and interpersonal skills to resolve bottlenecks.

The Research Manager will also develop and maintain research procedures for the Department with the goal of standardization, increased efficiency and ensuring compliance with Institutional guidelines. The Research Manager will coordinate the triage and priority process among the multiple and varied disease specialties within the Department.

The vision of the Department is to achieve and maintain national and regional leadership in radiation oncology discovery through clinical trials and outcomes reporting. The Research Manager assures that the programmatic strategic plan aligns with and supports the Department.

Duties & Responsibilities:

Research Development and Management: (45%)

Implement clinical trial initiatives in support of the strategic plan surrounding overall research in the sub-specialities of Radiation Oncology. Oversee and delegate appropriately day-to-day operations of investigator-initiated cooperative group trials, and collaborate with other departments on industry-initiated research studies, including:

Assisting faculty with clinical trial protocol development (faculty will write protocols, but there will need to be management of the "menu" of trials for appropriate balance)

Overseeing the study start up process, including budget development and negotiations, scientific review committee submission, IRB submission, and other relevant regulatory submissions.

Overseeing implementation of research protocols, work with process partners to ensure all protocol requirements are met

Overseeing and assisting faculty with data analysis

Overseeing study close-out process

Develop and maintain close relationships with both internal and external partners.

Develop and maintain research procedures for the Program with the goal of standardization, increased efficiency and ensuring compliance with Institutional guidelines.

Fiscal Management: (20%)

Communicate budget guidelines and restrictions to research staff to ensure overall fiscal compliance.

Oversee research billing by research staff is in accordance with current budget and UW procedures.

Recommend budget changes in accordance to clinical trial needs.

Collaborate with Assistant Director, Finance, Grants, and Contracts to develop budgets, ensure accurate billing, and financial record keeping

Collaborate with department Director and Assistant Director, to identify and implement strategies to mitigate areas of financial risk.

Staff Supervision: (35%)

Supervision of 7-10 clinical research staff, students, and administrative staff as necessary. Perform all aspects of supervision including hiring, training, and performance evaluation.

Manage successful research clinical trials and meet all regulatory and compliance guidelines

Assess protocol feasibility and advise Department leadership

Collaborate with internal and external partners

Maintain direct communication with faculty members, UW departments, funding sponsors, and research collaborators in support of the overall research plan.

Help identify problems with clinical trial start-up and management. Assist with organized improvement efforts and use problem solving and interpersonal skills to resolve bottlenecks. Assist with tracking measurement statistics, and communicate results to department leadership.

Minimum Requirements:

Bachelor's Degree in Science or related field or equivalent experience plus five years of progressive clinical research responsibilities

4 to 5 years' experience in clinical research including clinical trial management in a medical setting

Experience with Investigator-initiated and cooperative group trials

Certification as a Clinical Research Professional, SOCRA, CCRC, CCRP

Thorough knowledge of IRB and HIPAA regulatory requirements for the conduct of research, some knowledge of IACUC and FDA requirements

Experience working within the UW/FHCRC/SCCA desired

At least one year supervisory experience

Strong leadership, collaborative, interpersonal and communication skills

Excellent organizational skills and attention to detail

Demonstrated ability to make sound decisions and employ effective problem solving technique including strong analytical skills

Knowledge of clinical trials budgeting

Ability to prioritize competing demands to successfully meet deadlines and project milestones

Equivalent education/experience will substitute for all minimum qualifications

Desired Qualifications:

Experience in oncology clinical trials

Prior experience with UW clinical trial pricing processess, UW CRBB DBT for detailed clinical trials and other UW and SCCA study start-up forms desired

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.