Clinical Research Program Manager

Req : 239246 Department: GENERAL INTERNAL MEDICINE Posting Date: 09/24/2024 Closing Info:

Closes On 10/07/2024 Salary: $5,957 - $7,000 per month Limited Recruitment: Open to Department employees only Shift: First Shift Notes:

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. (https://hr.uw.edu/benefits/wp-content/uploads/sites/3/2018/02/benefits-professional-staff-librarians-academic-staff-20230701_a11y.pdf) 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 Division of General Internal Medicine has an outstanding opportunity for a Clinical Research Program Manager to join their team. The University of Washington’s Division of General Internal Medicine (GIM) is considered to be among the top Divisions of General Internal Medicine in the nation.

The Division has a workforce of over 550, with 460 faculty members who are known for their outstanding research, teaching and patient care. The Division conducts its activities at the UW Medical Center (UWMC-Montlake and Northwest), Harborview Medical Center (HMC), and the VA Puget Sound Health Care System (VAPSHCS) and VA Boise, with research sites located at multiple sites across Seattle. GIM has faculty in seven academic primary care clinics as well as in neighborhood clinics located across the Puget Sound, and manages inpatients at four Seattle area hospitals.

GIM is the largest division in the Department of Medicine and includes both clinical and research functions with a total annual budget of over $110m. Faculty and staff are spread over 10 sites around Seattle and the Puget Sound as well as in Boise, Idaho. The Division of General Internal Medicine in the Department of Medicine – Tsui Research Program, has an outstanding opportunity for a Clinical Research Program Manager.

This individual will be responsible for the following areas: Research Study Management Regulatory Compliance Communication, Training, Supervision, Employee Assessment, and Leadership POSITION PURPOSE The individual in this position will be responsible for overseeing research, data, and administrative efforts for multiple research studies and programs within the Tsui Research Group in General Internal Medicine. The Research Manager will work closely with the Principal Investigator (PI) Dr.

Tsui and a small team in a highly collaborative environment. This position involves the management of many different projects with external and internal collaborators and varying funding sources, with the primary projects being NIH-sponsored research projects/programs. Under the direction of the PI, this position is responsible for the administrative aspects of running the research programs including monitoring research timelines, reporting on progress, assuring research compliance, tracking budgets and working with grants management specialists on post-award funding administration, onboarding and supervising staff and student volunteers involved in specific studies and projects.

The ideal candidate will be a skilled communicator with a strong project and staff management background as well as experience in clinical research including the recruitment and consenting of participants as well as the implementation of research activities (studies visits, survey administration and specimen collection). This individual will supervise a team of program and research staff at the coordinator and assistant level. For NIH-funded research, the Research Manager will assist with submission of annual progress reports and keeping publications adherent to NIH requirements. Additionally, this position will directly oversee some activities of data reporting and feedback which will involve managing IRB submissions and renewals, reporting on ClinicalTrials.gov, datashare agreements, creating and maintaining RedCap surveys, storing data, assisting in developing data reports, and working with internal and external stakeholders who are essential to team science and research programs. DUTIES AND RESPONSIBILITIES Research Study Management

• 50% Oversee study planning, implementation, monitoring and close-out. Create and maintain project timelines, prioritize study tasks, develop data quality procedures, problem-solve with staff on issues pertaining to active protocols and recruitment.
  
  Compile study recruitment data on a weekly/monthly basis for meetings with study principal investigator and team. Identify and implement process improvements to enhance efficient functioning of study team, including full-time and part-time staff, trainees, volunteers and external collaborators. Participate in budget oversight and communications with grants management specialists to ensure that invoicing is occurring on a timely basis and study expenditures are staying within budget Create and maintain study source documentation and ensure timely completion of data entry by study staff.
  
  Create and maintain study databases. Ensure that research is adhering to expectations for data stewardship and expectations for data sharing are satisfied. Responsible for development and on-going maintenance of study-specific research materials such as Standard Operating Procedures (SOPs) and protocols.
  
  Responsible for administration of study procedures according to protocol, regulatory and sponsor specifications. Plan and participate in monitoring visits by Sponsor. Review and respond to Sponsor findings during monitoring visits and design and implement corrective actions as needed. Support PI and trainees in activities related to new grant applications/research proposals including study design, literature review, data visualization, tracking/formatting of documents, creation of analytic plans and submission of IRB applications.Regulatory Compliance

• 20% Manage regulatory compliance with current institutional, governmental and industry regulations for all studies conducted by the Tsui Research Group. Prepare and review initial IRB applications, consent forms, and data collection forms Oversee preparation of study renewals and modifications, including responsibility for compilation of screening and enrollment data for annual status reports to IRB and NIH. Maintain study regulatory database, including records of study funding and CT.gov database Oversee and participate in local and federal audits or requests for data reporting pertaining to regulatory compliance and studies completed at the clinic

Communication, Supervision, and Leadership

• 30% Act as primary liaison between investigators, sponsors, including federal agencies regarding study conduct and regulatory compliance. Attend institutional meetings relevant to the Tsui Research Program.
  
  Coordinate all communication with the IRB and Sponsors. Advise co-investigators, trainees, and staff in regulatory matters and in the conduct of clinical study procedures to ensure proper execution of study protocols. Assign work to study coordinators and other study personnel including but not limited to IRB applications, modifications, study renewals, and on-going study tasks such as data entry and study document creation, SOPs.
  
  Review work when task complete. Serves as a critical resource to other personnel and mentees in the Tsui Research program at the for matters relating to the implementation of policies and procedures in clinical research studies. Oversee work hours/attendance and assess the performance of other study personnel, provide guidance and/or corrective actions as needed.
  
  Develop job descriptions, assess and rank applicants, conduct interviews, and conduct hiring/onboarding to ensure efficiency in new hires MINIMUM REQUIREMENTS Bachelor’s Degree in a field related to the biological sciences and three years of related experience in research or equivalent education/experience Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration. ADDITIONAL REQUIREMENTS Knowledge of research data collection requirements and specialized clinical intervention/measurement/assessment skills as required by the projects. A thorough understanding of regulatory policies governing NIH clinical research practices, HIPAA requirements for clinical research, and knowledgeable about patient safety and quality control requirements.
  
  Excellent written and verbal communication skills, organizational skills and interpersonal skills. Ability to work independently, and to provide leadership in a team setting. Previous experience in a clinical/hospital setting.
  
  Good organizational and communication skills. Must demonstrate a strong attention to detail and ability to follow-through with tasks. Previous computer experience including database management and/or development, using Word, Excel, PowerPoint, Endnote, Adobe Illustrator, RedCap and Access.
  
  DESIRED QUALIFICATIONS Master's degree and 1-2 years experience in: Medical terminology and knowledge of substance use disorders is highly desired. Experience with clinical trials research or human subjects data collection experience.
  
  Demonstrated experience in working through the development, implementation, and closeout phases of research projects. Prior supervisory, staff training and leadership experience. Ability to work independently.
  
  Previous work experience in an Addictions Research setting preferred. Experience with Institutional Review Board applications and modifications. Experience with submission of NIH progress reports.
  
  Ability to troubleshoot technology issues. 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. University of Washington is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to, among other things, race, religion, color, national origin, sexual orientation, gender identity, sex, age, protected veteran or disabled status, or genetic information.