CLINICAL RESEARCH MANAGER

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.

The Department of Neurology has an outstanding opportunity for a Clinical Research Manager to join their team.

DUTIES AND RESPONSIBILITIES

Clinical Research Development and Management: 30%

Be the department expert for all grants, contracts, and finance issues that are related to clinical research.

Triage and manage the day-to-day operations

The study start-up process, including budget development and negotiations, scientific review committee submission, IRB submission, and other relevant regulatory submissions

Working with process partners to ensure all protocol requirements are met

Overseeing implementation of research protocols, study close-out process, record retention and compliance requirements

Assisting faculty with data analysis and financial decision

Maintain direct communication with faculty and staff members within and external to the Department of Neurology, UW departments, funding sponsors, and research collaborators in support of individual studies and the entire research program.

Involve physician leadership and administrative leadership as appropriate to identify and ameliorate issues with clinical trial implementation.

Use problem-solving and interpersonal skills to assist with organized process improvement efforts and identify study issues and solutions.

Interface with the University Office of Sponsored Programs (OSP), Grants and Contracts Accounting (GCA), and funding agencies (federal, foundations, and pharma).

Ensure compliance with sponsor, federal, state, and university guidelines and regulations as well as meeting reporting requirements issued by sponsors.

Communicate with individuals or entities external to UW Neurology who are interested in referring patients to UW Neurology clinical trials
Staff Supervision and Training: 30%

Supervision of clinical research staff, including research coordinators, data coordinators, regulatory coordinators, and research assistants

Responsible for recruitment, selection, training, merit and compensation review, performance management, regulatory compliance (FLSA, FMLA, EEO, and ADA), and staff development.

Develop and maintain research procedures for the Department with the goal of standardization, increased efficiency, and compliance with institutional guidelines.

Assist in ordering tests and procedures to facilitate protocol adherence, billing compliance, and to ensure accurate and reliable data collection.

Assist in monitoring patients and interacting with clinical providers to ensure patient safety and protocol adherence.

In partnership with the Associate Director, provide training to faculty, and staff in the pre-and post-award process.

Provide ongoing training and written materials to PIs, administrative and research staff regarding policies, procedures, regulations, and identified problem areas. In addition, share the updates with the group as needed.

Develop and maintain close relationships with both internal and external partners

Serve as backup to the clinical research staff
Revenue Cycle and Financial Risk Management: 30%

Direct all clinical trials-related activities including overseeing and managing the technical, legal, financial, and administrative components for the clinical research group.

Ensure grant and contract operational and deliverable requirements are met.

Work closely with the post-award team to provide frequent revenues projections vs expenditures, based on research study accrual and contract terms, to the PIs and/or clinical research staff. Specifically, analyze funding to ensure faculty and staff will be adequately funded.

Perform comprehensive and independent review of all funding information related to individual research studies, including but not limited to study budgets, protocols, consent forms, contracts, and other supporting documentation.

Coordinate the submission of the eGC1s with the Administrative Business Center (ABC) team in accordance with OSP requirements and deadlines.

Provide strategic, intellectual, and technical assistance to faculty and staff on clinical research revenue cycle policies, compliance, and regulatory matters.

In partnership with the Associate Director of Research, meet with the Vice-Chair of Research for the Department of Neurology regularly to review trial activities.
Other Duties as Assigned: 10%
MINIMUM REQUIREMENTS

Bachelor's degree in Business, Finance, Public Health, or other related fields.

4 years of experience
Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.
ADDITIONAL REQUIREMENTS

At least 2 years of experience directly managing and supervising staff successfully

Experience with Investigator-initiated and cooperative group trials

Creative and solution-focused problem-solving skills

Excellent written and oral communication, ability to effectively communicate with diverse audiences and patient populations

Excellent organizational skills and attention to detail

Demonstrated track record of prioritizing competing demands to successfully meet deadlines and project milestones

Knowledge of clinical trials budgeting

Experience with writing policy reports or similar documents intended for public consumption

Ability and willingness to work well in a fast-paced and dynamic environment, absorb new information quickly, and contribute meaningfully to the development and execution of projects
DESIRED QUALIFICATIONS

Master's degree in business, public health or other related field

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
Application Process: The application process 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 access 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 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.
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 [redacted] or [redacted].
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.