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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. All of which has allowed the UW to be nationally recognized as a “Great College to Work For” for six consecutive years.
The Department of Medicine has been deeply dedicated to its mission of teaching, research, and patient care. More than fifty years later, these commitments remain our core commitments. We continue annually to increase the University's standing in procurement of competitive extramural research funds. Currently, we are third in the nation for departments of medicine for funding from the National Institutes of Health.
The clinic is also one of nine sites within the NIH Vaccine and Treatment Evaluation Units (VTEUs) that conduct clinical trials to evaluate vaccines and treatments for emerging and re-emerging infectious diseases and we anticipate a large portfolio of studies focused on COVID-19 treatment and prevention.
The Department of Medicine – Virology Research Clinic has an outstanding opportunity for a Clinical Research Program Manager. This individual will be responsible for the following areas:
Communication, Supervision, and Leadership
Lead research coordinator for up to 5 complex clinical trials and/or research studies.
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.
Compile study data for quarterly meetings with administrative oversight personnel in the Virology Division at the Fred Hutchinson Cancer Research Center and on a weekly and monthly basis for meetings with study principal investigators.
Identify and responsible for implementing process improvements to enhance functioning of study team
Participate in budget preparation, including determining study staff effort on a protocol by- protocol basis.
Create and maintain study source documentation and ensure timely completion of data entry by study staff. Create and maintain study databases.
Responsible for development and on-going maintenance of study-specific research materials such as Standard Operating Procedures (SOPs)
Responsible for administration of study procedures according to protocol, regulatory and sponsor specifications.
Develop and write study protocols, protocol amendments and evaluate proposed protocols, both industry-sponsored and investigator-initiated.
Responsible for manuscript preparation
Participate in aspects of grant preparation and renewal process, including writing portions of grants and providing yearly enrollment reports
Facilitate and serve as a resource with collaborating researchers from both internal and external entities/institutions; coordinate Material Transfer Agreements
Attend scientific meetings
Manage regulatory compliance with current institutional, governmental and industry regulations for all studies conducted at the clinic.
Prepare and review initial IRB applications, consent forms, and data collection forms
Oversee preparation of study renewals and modifications, including responsible for compilation of screening and enrollment data for annual status reports.
Maintain study regulatory database, including records of study funding and Company website database
Orchestrate submissions of documents to FDA for IND applications
Oversee and participate in industry and federal audits pertaining to regulatory compliance and studies completed at the clinic
Communication, Supervision, and Leadership:
Act as primary liaison between investigators, sponsors, and federal agencies regarding study conduct and regulatory compliance. Attend institutional meetings relevant to the Virology Research Clinic
Coordinate all communication with the IRB.
Advise investigators, trainees, and clinical staff in all regulatory matters and in the conduct of clinical study procedures to ensure proper execution of study protocols
Assign work to study coordinators including but not limited to IRB applications, modifications, study renewals, and on-going study tasks such as data entry and study document creation. Review work when task complete.
Serves as a critical resources to managers and investigators at the Virology Research
Clinic for matters relating to the implementation of policies and procedures in clinical research studies.
As a UW employee, you will enjoy generous benefits and work/life programs. REQUIREMENTS:
BA in Biological Sciences or related field plus three years of related experience in a research clinic or equivalent education/experience
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 industry 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.
Previous computer experience including database management and/or development, using Word, Excel, PowerPoint, Endnote, Adobe Illustrator, and Access.
Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.
MPH is highly desired.
Five years experience with clinical activities required by the research projects.
Two years of clinical trials research or clinical data collection experience.
Experience with protocol development and clinical monitoring procedures required.
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 a Herpes setting preferred.
Experience in drafting Herpes study protocols
Experience with Human Subjects research
Experience with Institutional Review Board applications and modifications
CONDITIONS OF EMPLOYMENT
Recurring stringent deadlines require working beyond the normal work week to meet proposal submission and other project deadlines.
Must be able to communicate clinical information in English to clinicians, nursing, support staff and patients.
Visual verification of small print (as small as font size 9) between two to three references (labels, list, and requisitions) is required.
Will work with patients who have infectious diseases.
Will work in a clinical setting with specimens containing bloodbourne pathogens and biohazardous materials on a regular basis.
Must be comfortable talking about sexual history and various sexual practices to patients
Potential for exposure to bloodborne pathogens through needlestick or biohazard spill.
May spend long periods of time working on a computer/keyboard.
May have to lift up to 40 pounds
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.
Committed to attracting and retaining a diverse staff, the Company 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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