| n | Job Description: | n | Senior Clinical Research Coordinators with the Genitourinary Medical Oncology (GU Med Onc) program i |
| | | ndependently coordinate and are accountable for the overall administration of one or more clinical s |
| | | tudies, typically requiring advanced-level knowledge and skills. They may provide leadership to lowe |
| | | r-level clinical research coordinators and/or other support personnel. |
| Senior Clinical Research Coordinators with the Genitourinary Medical Oncology (GU Med Onc) program i | | |
| ndependently coordinate and are accountable for the overall administration of one or more clinical s | | |
| tudies, typically requiring advanced-level knowledge and skills. They may provide leadership to low | | |
| er-level clinical research coordinators and/or other support personnel. This Senior Clinical Researc | | |
| h Coordinator will support GU Med Onc in study activation, study amendment submissions, and the acti | | |
| vation and oversight of investigator initiated trials (IITs) with subsites. The position is responsi | | |
| ble for, and critically important to the overall operational management of clinical research activit | | |
| ies. It has direct responsibility for implementing a diverse portfolio of research activities for o | | |
| ne or more studies which may include multicenter clinical trials (both NIH and industry-sponsored), | | |
| local investigator-initiated clinical trials, and/or programmatic clinical research activities, such | | |
| as a clinical database and biorepository. Positions at this level may perform expert and efficient | | |
| integration of multiple complex programmatic activities, applying a sophisticated medical knowledge | | |
| base, substantial leadership skills, effectively working with a variety of people and organizations | | |
| at UCSF (clinicians, investigators, clinical staff, administration, Committee on Human Research, hu | | |
| man resources, contracts and grants) and elsewhere (industry sponsors, coordinating centers, FDA, NI | | |
| H), exhibiting an in-depth knowledge of specific programs. Reporting to a Principal Investigator (PI | | |
| ) or Director, the incumbent may have central responsibility for ensuring CHR approval and complianc | | |
| e, contract generation, negotiation and approval, subject recruitment, appropriate study testing, an | | |
| d adequate enrollment of multicenter clinical trials, longitudinal cohort studies, local investigato | | |
| r-initiated studies, and biorepository efforts; exercise strong administration and management leader | | |
| ship of clinical research, strong research coordination, and may lead experienced personnel to ensur | | |
| e optimal systems for efficiency, compliance, safety, financial oversight, and contractual expertise | | |
| in negotiations and execution, as well as create and implement quality improvement processes. This | | |
| is a position of leadership whose main purpose is to ensure that clinical research commitments are m | | |
| et and that the programs maintain a reputation for excellence in all activities. Department Overview | | |
| : The 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 Institu | | |
| te. We combine basic science, clinical research, epidemiology, cancer control and patient care throu | | |
| ghout the University of California, San Francisco. Currently, the HDFCCC conducts over 700 clinical | | |
| trials across various departments. | | |
| | | |
| t | Qualifications: | t | This Senior Clinical Research Coordinator will support GU Med Onc in study activation, study amendm |
| | | ent submissions, and the activation and oversight of investigator initiated trials (IITs) with subsi |
| | | tes. |
| Required Qualifications: • BS/BA degree in a related area and/or equivalent experience/training. Suf | | |
| ficient experience and demonstrated skills to successfully perform the assigned duties and responsib | | |
| ilities; and/or equivalent experience/training. • Demonstrated ability to develop recruitment strate | | |
| gies in complex environments and differing patient pools, independently identifying recruitment lead | | |
| s, implementing new strategies, and continually adjusting strategies to meet current recruitment goa | | |
| ls. • In-depth knowledge of clinical research contracts and grants, clinical trials, protocols, FDA | | |
| regulations, and complex visit structures. • Project management skills to oversee the administrative | | |
| operations of the clinical trials program; knowledge of strategies for recruiting human subjects. • | | |
| Exceptional analytical skills to evaluate the importance and urgency of problems; excellent demonst | | |
| rated interpersonal, verbal and written communication skills. • Ability to analyze complex and non-r | | |
| outine issues requiring innovative solutions. • Ability to operate effectively in a changing organiz | | |
| ational and technological environment. • Ability to assess and respond to audit risk; ability to dev | | |
| elop project plans/schedules and motivate team to meet deadlines. • Ability to interpret and apply p | | |
| olicies and regulations. • Financial analysis skills; demonstrated skills in preparing and presentin | | |
| g financial and quantitative analyses, including financial projections and budgets. • Significant pr | | |
| oject and clinical trial management experience or progressively responsible experience in a related | | |
| position including regulatory and compliance responsibilities. • Experience using database software, | | |
| such as MS Access or FileMaker Pro. • Ability to obtain certification by the Society of Clinical Re | | |
| search Associates or the Association of Clinical Research Professionals within one year of date of h | | |
| ire. Preferred Qualifications: • Fluency in spreadsheet software; ability to develop complex spreads | | |
| heets independently; demonstrated skills in audit preparation, execution, and follow-up. • Experienc | | |
| e in risk management regarding study subjects, federal and non-federal sponsors and regulating bodie | | |
| s. • Experience with grant application procedures, personnel documentation, contract generation and | | |
| subcontracting, preferably at UCSF. • Certification by the Society of Clinical Research Associates o | | |
| r the Association of Clinical Research Professionals. | | |
| | | The position is responsible for, and critically important to the overall operational management of |
| | | clinical research activities. It has direct responsibility for implementing a diverse portfolio of r |
| | | esearch activities for one or more studies which may include multicenter clinical trials (both NIH a |
| | | nd industry-sponsored), local investigator-initiated clinical trials, and/or programmatic clinical r |
| | | esearch activities, such as a clinical database and biorepository. Positions at this level may perfo |
| | | rm expert and efficient integration of multiple complex programmatic activities, applying a sophisti |
| | | cated medical knowledge base, substantial leadership skills, effectively working with a variety of p |
| | | eople and organizations at UCSF (clinicians, investigators, clinical staff, administration, Committe |
| | | e on Human Research, human resources, contracts and grants) and elsewhere (industry sponsors, coordi |
| | | nating centers, FDA, NIH), exhibiting an in-depth knowledge of specific programs. |
| | | |
| | | Reporting to a Principal Investigator (PI) or Director, the incumbent may have central responsibili |
| | | ty for ensuring CHR approval and compliance, contract generation, negotiation and approval, subject |
| | | recruitment, appropriate study testing, and adequate enrollment of multicenter clinical trials, long |
| | | itudinal cohort studies, local investigator-initiated studies, and biorepository efforts; exercise s |
| | | trong administration and management leadership of clinical research, strong research coordination, a |
| | | nd may lead experienced personnel to ensure optimal systems for efficiency, compliance, safety, fina |
| | | ncial oversight, and contractual expertise in negotiations and execution, as well as create and impl |
| | | ement quality improvement processes. This is a position of leadership whose main purpose is to ensur |
| | | e that clinical research commitments are met and that the programs maintain a reputation for excelle |
| | | nce in all activities. |
| | | |
| | | Department Overview: |
| | | |
| | | The 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 Institut |
| | | e. We combine basic science, clinical research, epidemiology, cancer control and patient care throug |
| | | hout the University of California, San Francisco. Currently, the HDFCCC conducts over 700 clinical t |
| | | rials across various departments. |