Protocol Project Manager

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:,ActualValueFromSolar:null},{QuestionName:Job Summary,AnswerValue:JOB OVERVIEWu003cbr/u003eThe Protocol Project Manager (PPM) will work in the Pediatric Oncology Program and serve as the main point of contact between Principal Investigators and Sponsors, during study activation. The individual will be accountable for clinical trial study start up, regulatory maintenance and close out.u003cbr/u003eu003cbr/u003eThe successful individual 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 team.u003cbr/u003e• Coordinate protocol reviews and submissions to Disease Site Committee and Protocol Review Committee.u003cbr/u003e• Identify ancillary committee approval with study team required by a protocol and initiate the process for review.u003cbr/u003e• Assist Principal Investigator (PI) with the development of concept sheets, IRB applications, investigational brochure or package insert for investigator initiated trials.u003cbr/u003e• Facilitate start-up at external sties for multi-site investigator initiated studiesu003cbr/u003e• Ensure timely processing of new protocols through the activation pipeline including Medicare coverage analysis and budget sign off, informed consent approval and IRB submission, contract execution, and billing set up.u003cbr/u003e• Ensure policies mandated by the Helen Diller Family Comprehensive Cancer Center (HDFCCC), federal government, any outside entity and study team are followed during trial activation pipeline, maintenance phase and close-out.u003cbr/u003e• Coordinate and prepare for sponsor or collaborator visits such as site initiation, audit and monitor visits.u003cbr/u003e• Update clinical trial management databases.u003cbr/u003e• Assist study team to develop contingency action plans.u003cbr/u003e• Flexibility to adapt to changing circumstances.u003cbr/u003e• Excellent organizational skills, multitasking and communication both written and spoken.u003cbr/u003eu003cbr/u003eu003cbu003e Note: Physical/health screening required. u003c/bu003eu003cbr/u003eu003cbr/u003eHELEN DILLER FAMILY COMPREHENSIVE CANCER CENTERu003cbr/u003eThe UCSF Helen Diller Family Comprehensive Cancer Center (HDFCCC) is a national leader in oncology research. The HDFCCC clinical research program is a fast paced program with a broad portfolio of clinical trials. The mission of the UCSF HDFCCC clinical research program is to provide patients and their families with streamlined access to cutting-edge cancer therapies, In addition to providing compassionate, patient-centered care, our team of clinicians and researchers is dedicated to improving outcomes for all patients.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:55410BR,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,VerityZone:formtext10,QuestionType:text,ActualValueFromSolar:null},{QuestionName:Appointment Type,AnswerValue:Career,VerityZone:formtext12,QuestionType:radio,ActualValueFromSolar:null},{QuestionName:Percentage,AnswerValue:100%,VerityZone:formtext13,QuestionType:Text,ActualValueFromSolar:null},{QuestionName:Shift Length,AnswerValue:8 Hours ,VerityZone:formtext14,QuestionType:Radio,ActualValueFromSolar:null},{QuestionName:Shift,AnswerValue:Days,VerityZone:formtext15,QuestionType:Checkbox,ActualValueFromSolar:null},{QuestionName:Work Days,AnswerValue:Monday – Friday; 8 hours/day,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 responsibilities. u003cbru003e• Individual who are selected for this position without the Society of Clinical Research Associates ( SOCRA) or the Associate of Clinical Research Professionals ACRP) shall be required to obtain the certification within one year of starting this job at UCSFu003cbru003e• Working knowledge of Microsoft Office applications such as Word, PowerPoint, Project and Excel.u003cbru003e• Project management skills to oversee the administrative operations of the clinical trials program; knowledge of strategies for recruiting human subjects. u003cbru003e• Significant project and clinical trial management experience or progressively responsible experience in a related position including regulatory and compliance responsibilities. u003cbru003e• Experience with clinical trials regulatory affairs, or related clinical trials experience such clinical research coordinator experience.u003cbru003e• Working knowledge of clinical trial design, clinical study operations, or regulatory approval process. u003cbru003e• 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 goals.u003cbru003e• Exceptional analytical skills to evaluate the importance and urgency of problems; excellent demonstrated interpersonal, verbal and written communication skills. u003cbru003e• Demonstrated ability to work within a team environment with faculty and staff at all levels. u003cbru003e• Experience working with medical providers and personnel.u003cbru003e• Ability to interpret and apply policies and regulations. u003cbru003e• Ability to analyze complex and non-routine issues requiring innovative solutions. u003cbru003e• Ability to operate effectively in a changing organizational and technological environment. u003cbru003e• Ability to assess and respond to audit risk; ability to develop project plans/schedules and motivate team to meet deadlines.,VerityZone:formtext3,QuestionType:textarea,ActualValueFromSolar:null},{QuestionName:Preferred Qualifications,AnswerValue:• Bachelor’s degree, preferably in the biological sciences or a related field.u003cbru003e• In-depth knowledge of clinical research contracts and grants, clinical trials, protocols, FDA regulations, and complex visit structures.u003cbru003e• 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 budgets.u003cbru003e• Fluency in spreadsheet software; ability to develop complex spreadsheets independently; demonstrated skills in audit preparation, execution, and follow-up. u003cbru003e• Experience in risk management regarding study subjects, federal and non-federal sponsors and regulating bodies. u003cbru003e• Experience with grant application procedures, personnel documentation, contract generation and subcontracting, preferably at the location.u003cbru003e• Experience with oncology clinical trials, or related therapies in drug clinical trials.u003cbru003e• Exposure to, or on the job use of, medical terminology. u003cbru003e• Experience preparing submissions for IRB, IND safety reporting, or continuing reviews. u003cbru003e• Experience with clinical trials management software such as OnCore.,VerityZone:formtext4,QuestionType:textarea,ActualValueFromSolar:null},{QuestionName:License/Certification,AnswerValue:• Individual who are selected for this position without the Society of Clinical Research Associates ( SOCRA) or the Associate of Clinical Research Professionals ACRP) shall be required to obtain the certification within one year of starting this job at UCSF,VerityZone:formtext5,QuestionType:textarea,ActualValueFromSolar:null},{QuestionName:Position Type,AnswerValue:Full 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:3042,isGQResponsive:true,isActive:true,isSocialReferralJobRestricted:false,localeId:1033,AutoOptionalReqId:55410BR,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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