Protocol Project Manager - GI Program

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:,ActualValueFromSolar:null},{QuestionName:Job Summary,AnswerValue:JOB OVERVIEWu003cbr/u003eThe Protocol Project Manager (PPM) will work in the Gastrointestinal research program and serve as the main point of contact between the study team including faculty and clinical research coordinators (CRC), outside entities such as sponsors, and the Interventional Trials Resource (ITR), which is a centralized service unit in the Helen Diller Family Comprehensive Cancer Center (HDFCCC) offering clinical trial management services. The candidate will be accountable for clinical trial study start up, maintenance and close out. u003cbr/u003eu003cbr/u003eA successful applicant will thrive in a fast-paced environment, take initiative, and resolve problems and provide clarity in ambiguous situations. We are looking for a go-getter with excellent relationship building skills, and a team player who can also work independently. u003cbr/u003eu003cbr/u003eDuties Include:u003cbr/u003e• Complete pre-activation tasks such as feasibility surveys and assessment with study teamu003cbr/u003e• Coordinate protocol reviews and submissions to Disease Site Committee and Protocol Review Committeeu003cbr/u003e• Identify ancillary committee approval with study team required by a protocol and initiate the process for reviewu003cbr/u003e• Assist Principal Investigator (PI) with the development of concept sheets, investigational brochure or package insert for the Investigational Trials Resource (ITR) regulatory protocol editor for investigator initiated trialsu003cbr/u003e• Ensure timely processing of new protocols through the activation pipeline including Medicare coverage analysis and budget sign off, informed consent approval and Institutional Review Board (IRB) submission, contract execution, and billing set upu003cbr/u003e• Ensure policies mandated by the HDFCCC, federal government, any outside entity and study team are followed during trial activation pipeline, maintenance phase and close-outu003cbr/u003e• Coordinate and prepare for sponsor or collaborator visits such as site initiation, audit and monitor visitsu003cbr/u003e• Update clinical trial management databasesu003cbr/u003e• Assist study team to develop contingency action plansu003cbr/u003e• Flexibility to adapt to changing circumstancesu003cbr/u003e• Excellent organizational skills, multitasking and communication both written and spoken.u003cbr/u003eu003cbr/u003eHELEN DILLER FAMILY COMPREHENSIVE CANCER CENTERu003cbr/u003eThe UCSF Helen Diller Family Comprehensive Cancer Center (HDFCCC) is the only cancer center in the Bay Area to receive the prestigious designation of “comprehensive” from the National Cancer Institute (NCI). We combine basic science, clinical research, epidemiology, cancer control and patient care throughout UCSF. Currently, the HDFCCC conducts over 700 clinical trials across various departments.u003cbr/u003eu003cbr/u003eABOUT UCSF u003cbr/u003eThe University of California, San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. It is the only campus in the 10-campus UC system dedicated exclusively to the health sciences.,VerityZone:jobdescription,QuestionType:textarea,ActualValueFromSolar:null},{QuestionName:Organization,AnswerValue:Campus,VerityZone:location,QuestionType:select,ActualValueFromSolar:null},{QuestionName:Req Number,AnswerValue:55679BR,VerityZone:autoreq,QuestionType:text,ActualValueFromSolar:null},{QuestionName:Location,AnswerValue:Mission Bay,VerityZone:formtext8,QuestionType:single-select,ActualValueFromSolar:null},{QuestionName:Job Title,AnswerValue:Protocol Project Manager - GI Program,VerityZone:formtext10,QuestionType:text,ActualValueFromSolar:null},{QuestionName:Appointment Type,AnswerValue:Career,VerityZone:formtext12,QuestionType:radio,ActualValueFromSolar:null},{QuestionName:Percentage,AnswerValue:60%,VerityZone:formtext13,QuestionType:Text,ActualValueFromSolar:null},{QuestionName:Shift Length,AnswerValue:Other,VerityZone:formtext14,QuestionType:Radio,ActualValueFromSolar:null},{QuestionName:Shift,AnswerValue:Days,VerityZone:formtext15,QuestionType:Checkbox,ActualValueFromSolar:null},{QuestionName:Work Days,AnswerValue:Monday – Friday; 24 hours/week,VerityZone:formtext16,QuestionType:Text,ActualValueFromSolar:null},{QuestionName:Required Qualifications,AnswerValue:• HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilitiesu003cbru003e• Ability to obtain certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals within one year of date of hireu003cbru003e• In-depth knowledge of clinical research contracts and grants, clinical trials, protocols, Food u0026 Drug Administration (FDA) regulations, and complex visit structuresu003cbru003e• Significant project and clinical trial management experience or progressively responsible experience in a related position including regulatory and compliance responsibilitiesu003cbru003e• Experience with clinical trials regulatory affairs, or related clinical trials experience such clinical research coordinator experienceu003cbru003e• Experience working with medical providers and personnelu003cbru003e• Working knowledge of clinical trial design, clinical study operations, or regulatory approval processu003cbru003e• Working knowledge of Microsoft Office applications such as Word, PowerPoint, Project and Excelu003cbru003e• Project management skills to oversee the administrative operations of the clinical trials program; knowledge of strategies for recruiting human subjectsu003cbru003e• Demonstrated ability to develop recruitment strategies in complex environments and differing patient pools, independently identifying recruitment leads, implementing new strategies, and continually adjusting strategies to meet current recruitment goalsu003cbru003e• Exceptional analytical skills to evaluate the importance and urgency of problems; excellent demonstrated interpersonal, verbal and written communication skillsu003cbru003e• Ability to analyze complex and non-routine issues requiring innovative solutionsu003cbru003e• Ability to assess and respond to audit risk; ability to develop project plans/schedules and motivate team to meet deadlinesu003cbru003e• Ability to interpret and apply policies and regulationsu003cbru003e• Ability to operate effectively in a changing organizational and technological environmentu003cbru003e• Demonstrated ability to work within a team environment with faculty and staff at all levelsu003cbru003eu003cbru003eu003cbu003eNote: Physical/health screening required. u003c/bu003e,VerityZone:formtext3,QuestionType:textarea,ActualValueFromSolar:null},{QuestionName:Preferred Qualifications,AnswerValue:• Bachelor’s degree, preferably in the biological sciences or a related fieldu003cbru003e• Licensure for management, healthcare and/or clinical trials coordination (i.e. PMP, CCRP, SoCRA)u003cbru003e• Financial analysis skills; demonstrated skills in preparing and presenting financial and quantitative analyses, including financial projections and budgetsu003cbru003e• Fluency in spreadsheet software; ability to develop complex spreadsheets independently; demonstrated skills in audit preparation, execution, and follow-upu003cbru003e• Experience in risk management regarding study subjects, federal and non-federal sponsors and regulating bodiesu003cbru003e• Experience with grant application procedures, personnel documentation, contract generation and subcontracting, preferably at the locationu003cbru003e• Experience with oncology clinical trials, or related therapies in drug clinical trialsu003cbru003e• Exposure to, or on the job use of, medical terminologyu003cbru003e• Experience preparing submissions for IRB, investigational drug applications (IND) safety reporting, or continuing reviewsu003cbru003e• Experience with clinical trials management software such as OnCore,VerityZone:formtext4,QuestionType:textarea,ActualValueFromSolar:null},{QuestionName:License/Certification,AnswerValue:• Ability to obtain certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals within one year of date of hire,VerityZone:formtext5,QuestionType:textarea,ActualValueFromSolar:null},{QuestionName:Position Type,AnswerValue:Part Time,VerityZone:formtext6,QuestionType:radio,ActualValueFromSolar:null},{QuestionName:Department Name,AnswerValue:Helen Diller Family Comprehensive Cancer Center,VerityZone:formtext17,QuestionType:text,ActualValueFromSolar:null},{QuestionName:Equal Employment Opportunity,AnswerValue:The University of California San Francisco is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.,VerityZone:formtext22,QuestionType:textarea,ActualValueFromSolar:null}],GQId:3103,isGQResponsive:true,isActive:true,isSocialReferralJobRestricted:false,localeId:1033,AutoOptionalReqId:55679BR,Title:Clinical Research Coordinator, Sr.,JobSiteId:5226,Link:****{Responsive_AdvancedCSS: \,Responsive_BackgroundColor: #ffffff,Responsive_BackgroundImage: ****#353a3f,Responsive_BaseFontFamily: \u0027Helvetica Neueu0027, Helvetica, Arial, sans-serif,Responsive_BaseFontSize: 16px,Responsive_ButtonBackgroundColor: #F48024,Responsive_CompiledCSS: /* remember to define focus styles! */input,select,.control,.ui-selectmenu-button,textarea,.pseudocheckbox,.pseudoradio,.controlWrapper,.textAreaWrapper,.lightBorder,.themed .ui-selectmenu-button,.ui-state-default { border-color: #353a3f;}.baseFontColor { color: #353a3f;}.baseColorPalette { background-color: #ffffff; 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