Only the job description changed.
| Previous Job Description | Current Job Description | ||||
|---|---|---|---|---|---|
| n | 1 | Job Description: | n | 1 | Senior Clinical Research Coordinators with the Pediatric Oncology program independently coordinate a |
| > | nd are accountable for the overall administration of one or more clinical studies, typically requiri | ||||
| > | ng advanced-level knowledge and skills. They may provide leadership to lower-level clinical research | ||||
| > | coordinators and/or other support personnel. | ||||
| 2 | Senior Clinical Research Coordinators with the Pediatric Oncology program independently coordinate a | ||||
| > | nd are accountable for the overall administration of one or more clinical studies, typically requiri | ||||
| > | ng advanced-level knowledge and skills. They may provide leadership to lower-level clinical researc | ||||
| > | h coordinators and/or other support personnel. The position is responsible for, and critically impor | ||||
| > | tant to the overall operational management of clinical research activities. It has direct responsib | ||||
| > | ility for implementing a diverse portfolio of research activities for one 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 b | ||||
| > | iorepository. Positions at this level may perform expert and efficient integration of multiple comp | ||||
| > | lex programmatic activities, applying a sophisticated medical knowledge base, substantial leadership | ||||
| > | skills, effectively working with a variety of people and organizations at UCSF (clinicians, investi | ||||
| > | gators, clinical staff, administration, Committee on Human Research, human resources, contracts and | ||||
| > | grants) and elsewhere (industry sponsors, coordinating centers, FDA, NIH), exhibiting an in-depth kn | ||||
| > | owledge of specific programs. Reporting to a Principal Investigator (PI) or Director, the incumbent | ||||
| > | may have central responsibility for ensuring CHR approval and compliance, contract generation, negot | ||||
| > | iation and approval, subject recruitment, appropriate study testing, and adequate enrollment of mult | ||||
| > | icenter clinical trials, longitudinal cohort studies, local investigator-initiated studies, and bior | ||||
| > | epository efforts; exercise strong administration and management leadership of clinical research, st | ||||
| > | rong research coordination, and may lead experienced personnel to ensure optimal systems for efficie | ||||
| > | ncy, compliance, safety, financial oversight, and contractual expertise in negotiations and executio | ||||
| > | n, as well as create and implement quality improvement processes. This is a position of leadership w | ||||
| > | hose main purpose is to ensure that clinical research commitments are met and that the programs main | ||||
| > | tain a reputation for excellence in all activities. Department Overview: The UCSF Helen Diller Famil | ||||
| > | y Comprehensive Cancer Center (HDFCCC) is the only cancer center in the Bay Area to receive the pres | ||||
| > | tigious designation of “comprehensive” from the National Cancer Institute. We combine basic science, | ||||
| > | clinical research, epidemiology, cancer control and patient care throughout the University of Calif | ||||
| > | ornia, San Francisco. Currently, the HDFCCC conducts over 700 clinical trials across various departm | ||||
| > | ents | ||||
| 3 | 2 | ||||
| t | 4 | Qualifications: | t | 3 | 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. | ||||
| 5 | Required Qualifications: - BS/BA degree in a related area; or equivalent experience/training - Signi | 4 | |||
| > | ficant project and clinical trial management experience or progressively responsible experience in a | ||||
| > | related position including regulatory and compliance responsibilities - Experience using database s | ||||
| > | oftware, such as MS Access or FileMaker Pro - In-depth knowledge of clinical research contracts and | ||||
| > | grants, clinical trials, protocols, FDA regulations, and complex visit structures - Financial analys | ||||
| > | is skills; demonstrated skills in preparing and presenting financial and quantitative analyses, incl | ||||
| > | uding financial projections and budgets - Demonstrated ability to develop recruitment strategies in | ||||
| > | complex environments and differing patient pools, independently identifying recruitment leads, imple | ||||
| > | menting new strategies, and continually adjusting strategies to meet current recruitment goals - Pro | ||||
| > | ject management skills to oversee the administrative operations of the clinical trials program; know | ||||
| > | ledge of strategies for recruiting human subjects - Exceptional analytical skills to evaluate the im | ||||
| > | portance and urgency of problems; excellent demonstrated interpersonal, verbal, and written communic | ||||
| > | ation skills - 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 - Ability to analyze | ||||
| > | complex and non-routine issues requiring innovative solutions - Ability to operate effectively in a | ||||
| > | changing organizational and technological environment - Ability to assess and respond to audit risk | ||||
| > | ; ability to develop project plans/schedules and motivate team to meet deadlines - Ability to interp | ||||
| > | ret and apply policies and regulations Preferred Qualifications: - Fluency in spreadsheet software; | ||||
| > | ability to develop complex spreadsheets independently; demonstrated skills in audit preparation, exe | ||||
| > | cution, and follow-up - Experience in risk management regarding study subjects, federal and non-fede | ||||
| > | ral sponsors, and regulating bodies - Experience with grant application procedures, personnel docume | ||||
| > | ntation, contract generation, and subcontracting, preferably at UCSF - Certification by the Society | ||||
| > | of Clinical Research Associates or the Association of Clinical Research Professionals License/Certif | ||||
| > | ication: - Ability to obtain certification by the Society of Clinical Research Associates or the Ass | ||||
| > | ociation of Clinical Research Professionals within one year of date of hire. | ||||
| 5 | 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. | ||||
| 6 | |||||
| 7 | Department Overview: | ||||
| 8 | |||||
| 9 | 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 | ||||