Clinical Research Coordinator - GI Division

TheClinicalResearchCoordinatorwilljointheGIDivisionandresponsibilitieswillincludecoordinationofclinicalresearchstudiesrelatedliverdiseaseandlivertransplantation.TheClinicalResearchCoordinatorwillperformindependentlyatthefullyoperationaljourneyleveloftheseriestoexecute,manage,andcoordinateresearchprotocols,asdirectedbythePrincipalInvestigators(PIs);maycoordinatethedatacollectionandoperationsofseveralconcurrentclinicalresearchstudiesundertheguidelinesofresearchprotocols,UCSFandregulatingagencypolicies. The incumbent will collaborate with two Principal Investigators in the GI Division-Drs. Lai and Price-on separate research studies Dutiesmayinclude,managementandcoordinatingthetasksofmultipleclinicalresearchstudies,actasintermediarybetweenservicesanddepartmentswhileoverseeingdataandspecimenmanagement;manageandreportonstudyresults;create,clean,update,andmanagedatabasesandcomprehensivedatasetsandreports;coordinatestaffworkschedules,assistwithtrainingofAssistantCRCs,andassistPIsupervisorwithoversightofotherresearchstaff;manageInvestigator'sprotocolsintheCommitteeonHumanResearchonlinesystem,aswellasrenewalsandmodificationsofprotocolapplicationsandtheimplementationofnewstudies;participateinthereviewandwritingofprotocolstoensureinstitutionalreviewboardapprovalwithinUniversitycompliance;helpassurecompliancewithallrelevantregulatoryagencies;overseestudydataintegrity;implementandmaintainperiodicqualitycontrolprocedures;interfacewithdepartmentstoobtainUCSFapprovalpriortostudyinitiation;maintainallregulatorydocuments;reportstudyprogresstoinvestigators;participateinanyinternalandexternalauditsorreviewsofstudyprotocols;andperformotherdutiesasassigned. Study Coordination and Data Collection Identify subjects, develop recruitment and retention strategies, and screen and enroll study subjects. Schedule subjects for study visits; meet with them to administer questionnaires, collect medical history and perform study procedures. Maintain rapport and relationships with subjects to ensure effective communication and retention; respond to their diverse needs, schedule follow-up appointments, and become their intermediary; discuss study outcomes with providers to ensure continuity of care. Obtain informed consent; review information with subjects; assess and advocate for patient safety throughout each protocol procedure. Oversee subject reimbursement; work to resolve discrepancies and issues. Work with staff to ensure procedures are completed, specimens properly stored, and required data collected at visits; and ensure correct shipping and labeling measures. Coordinate, communicate and network with other studies and technicians to ensure scheduling efficiency; communicate with any affiliated groups. Conduct reviews of medical charts and electronic records to extract medical information and other data for use in studies. Implement needs assessments and recommendations for enhancements on patient coordination, data collection, data management, protocol adherence and study collaboration. Set up approved studies in APEX, identify all study subjects in APEX to ensure research related expenses are billed to the study and that the patient's insurance is billed for standard of care expenses; Review APEX work queue on a daily basis, resolve incorrect patient billing issues; identify non-standard of care patient care costs and procedures related to the study, complete a monthly invoice form and provide it to the research finance analyst (RFA) for payment from the sponsor. Prepare check requests for participation in the study as well as for issuing reimbursement for travel, as stipulated in the consent form. Collect data during subject visits; enter data from visits, procedures, lab tests, and other subject- related participation into databases in a timely manner. Manage database structure for each protocol; update databases to improve data analysis and management; create new databases as needed. Create and maintain comprehensive data sets as requested by the CRC Supervisor and/or PI. Maintain data collection forms for effective data collection, entry, and analysis. Perform queries and analysis in databases. Work with Supervisor to maintain complete and accurate data in the study database; analyze the data as they become available. Oversee data integrity; initiate assessments of the adequacy of existing policies and procedures on subject recruitment, data collection, and data management. Update and maintain a procedure manual documenting all study-related procedures; help develop a plan to ensure consistency in data collection and data entry. Implement and maintain periodic quality control procedures Suggest modifications to the administrative infrastructure to accommodate increasing complexity of studies. Modify data collection instruments Help schedule staff time and coordinate staff schedules. Maintain subject tracking systems. Arrange the exchange of and transport of specimens with collaborating Investigators and staff. Oversee the incoming data interpreted from samples and ensure that it is utilized correctly for analysis and publications. Ensure integrity and security of samples. Enter all existing and new study protocols into the Committee on Human Research (CHR) online system; seek assistance on maintaining all protocols in the system by communicating with CHR Analysts. Design and enhance case report forms and data collection forms as needed; provide manuscript feedback; continue to develop and maintain systems for assuring protocol adherence and data quality. Participate in the review and writing of protocols and related procedures to ensure institutional review board approval within University compliance. Renew, modify, and submit CHR applications and protocols; ensure that protocol applications are submitted in a timely manner; serve as a liaison between CHR and study Investigators. Provide quality assurance checks to note if protocols or UCSF CHR applications need to be modified; evaluate protocols on an ongoing basis and implement improvements as needed. Assure studies are carried out according to Code of Federal Regulations, Good Clinical Practice, and UCSF regulations. Initiate and follow-up on CHR submissions and modifications; track approval status. Interface with departments to obtain UCSF approval prior to study initiation. Maintain regulatory documents; monitor timelines for data submission; document adverse events and submit to appropriate departments. Use sound judgment to maintain patient confidentiality when communicating with agencies, healthcare providers, other studies, and outside departments. Participate in and cooperate with any internal and external audits or reviews of study protocols; prepare necessary documentation. Data management and reporting of results Quality control procedures Study Implementation Specimen Management/ Maintenance Protocol Submissions and Adherence Regulatory responsibilities Required Qualifications HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities; and/or equivalent experience/training Attention to detail; strong interpersonal skills; excellent, effective verbal and written communication skills to coordinate with subjects, team members, other departments and outside institutions; and the ability to multi-task in a fast-paced environment while working with a diverse subject population Ability to work well independently, complete projects in a timely manner, and prioritize multiple projects to ensure the completion of essential tasks by deadlines Preferred Qualifications BA/BS degree in physical or biological sciences and one year of clinical research experience, or a combination of experience and education Fluency in the usage of Committee of Human Research (CHR) online iMEDris system for submission, renewal, and modification of protocols through this system Understanding of patient population to create rapport and a relationship, while also giving insight to what is realistic and appropriate for patient participation Experience with electronic medical records Knowledge of UCSF and departmental policies for dealing with reimbursement, guidelines for research, confidentiality and HIPPA regulations, following the UCSF mission statement and purpose for research, and a clear understanding of policies and procedures on patient safety and confidentiality (electronic and hard copy medical records, patient charts, communication, etc.) Knowledge of medical terminology, research policies and guidelines, guidelines for packing/shipping infectious substances, database building/analysis, and data management within some of the following: Access, Stata, SASS/ SPSS, and Teleform programming platforms Experience applying the following regulations and guidelines: GoodClinicalPracticeGuidelines HealthInformationandAccountabilityAct(HIPAA) TheProtectionofHumanResearchSubjects CHRregulationsforrecruitmentandconsentofresearchsubjects EffectiveCashHandlingProcedures EnvironmentalHealthandSafetyTraining FireSafetyTraining About UCSF The 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. We bring together the world's leading experts in nearly every area of health. We are home to five Nobel laureates who have advanced the understanding of cancer, neurodegenerative diseases, aging and stem cells. Pride Values UCSF is a diverse community made of people with many skills and talents. We seek candidates whose work experience or community service has prepared them to contribute to our commitment to professionalism, respect, integrity, diversity and excellence - also known as our PRIDE values. In addition to our PRIDE values, UCSF is committed to equity - both in how we deliver care as well as our workforce. We are committed to building a broadly diverse community, nurturing a culture that is welcoming and supportive, and engaging diverse ideas for the provision of culturally competent education, discovery, and patient care. Additional information about UCSF is available here. Equal Employment Opportunity The University of California is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected status under state or federal law. Salary Information The final salary and offer components are subject to additional approvals based on UC policy. Your placement within the salary range is dependent on a number of factors including your work experience and internal equity within this position classification at UCSF. For positions that are represented by a labor union, placement within the salary range will be guided by the rules in the collective bargaining agreement. To learn more about the benefits of working at UCSF, including total compensation, please visit: #J-18808-Ljbffr University of California - San Francisco