Only the job description changed.
| Previous Job Description | Current Job Description | ||||
|---|---|---|---|---|---|
| n | 1 | Job Description: | n | 1 | Senior Clinical Research Coordinators independently coordinate and are accountable for the overall a |
| > | dministration of one or more clinical studies, typically requiring advanced-level knowledge and skil | ||||
| > | ls. They may provide leadership to lower-level clinical research coordinators and/or other support p | ||||
| > | ersonnel. | ||||
| 2 | Senior Clinical Research Coordinators independently coordinate and are accountable for the overall a | ||||
| > | dministration of one or more clinical studies, typically requiring advanced-level knowledge and skil | ||||
| > | ls. They may provide leadership to lower-level clinical research coordinators and/or other support p | ||||
| > | ersonnel. The position is responsible for, and critically important to the overall operational manag | ||||
| > | ement of clinical research activities. It has direct responsibility for implementing a diverse port | ||||
| > | folio 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 biorepository. Positions at this leve | ||||
| > | l may perform expert and efficient integration of multiple complex programmatic activities, applying | ||||
| > | a sophisticated medical knowledge base, substantial leadership skills, effectively working with a v | ||||
| > | ariety of people and organizations at UCSF (clinicians, investigators, clinical staff, administratio | ||||
| > | n, Committee on Human Research, human resources, contracts and grants) and elsewhere (industry spons | ||||
| > | ors, coordinating centers, FDA, NIH), exhiting an in-depth knowledge of specific programs. Reporting | ||||
| > | to a Principal Investigator (PI) or Director, the incumbent may have central responsibility for ens | ||||
| > | uring CHR approval and compliance, contract generation, negotiation and approval, subject recruitmen | ||||
| > | t, appropriate study testing, and adequate enrollment of multicenter clinical trials, longitudinal c | ||||
| > | ohort studies, local investigator-initiated studies, and biorepository efforts; exercise strong admi | ||||
| > | nistration and management leadership of clinical research, strong research coordination, and may lea | ||||
| > | d experienced personnel to ensure optimal systems for efficiency, compliance, safety, financial over | ||||
| > | sight, and contractual expertise in negotiations and execution, as well as create and implement qual | ||||
| > | ity | ||||
| 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), exhiting an in-depth knowledge of specific programs. | ||||
| 5 | Required Qualifications: - Bachelor’s degree in related area and sufficient experience and demonstra | 4 | |||
| > | ted skills to successfully perform the assigned duties and responsibilities and/or equivalent experi | ||||
| > | ence/training. - Demonstrated ability to develop recruitment strategies in complex environments and | ||||
| > | differing patient pools, independently identifying recruitment leads, implementing new strategies, a | ||||
| > | nd continually adjusting strategies to meet current recruitment goals. - In-depth knowledge of clini | ||||
| > | cal research contracts and grants, clinical trials, protocols, FDA regulations, and complex visit st | ||||
| > | ructures. - Project management skills to oversee the administrative operations of the clinical trial | ||||
| > | s program; knowledge of strategies for recruiting human subjects. - Exceptional analytical skills to | ||||
| > | evaluate the importance and urgency of problems; excellent demonstrated interpersonal, verbal and w | ||||
| > | ritten communication skills. - Ability to analyze complex and non-routine issues requiring innovativ | ||||
| > | e solutions. - Ability to operate effectively in a changing organizational and technological environ | ||||
| > | ment. - Ability to assess and respond to audit risk; ability to develop project plans/schedules and | ||||
| > | motivate team to meet deadlines. - Ability to interpret and apply policies and regulations. - Financ | ||||
| > | ial analysis skills; demonstrated skills in preparing and presenting financial and quantitative anal | ||||
| > | yses, including financial projections and budgets. - Significant project and clinical trial manageme | ||||
| > | nt experience or progressively responsible experience in a related position including regulatory and | ||||
| > | compliance responsibilities. - Experience using database software, such as MS Access or FileMaker P | ||||
| > | ro. - Ability to obtain certification by the Society of Clinical Research Associates or the Associat | ||||
| > | ion of Clinical Research Professionals within one year of date of hire. Preferred Qualification: - F | ||||
| > | luency in spreadsheet software; ability to develop complex spreadsheets independently; demonstrated | ||||
| > | skills in audit preparation, execution, and follow-up. - Experience in risk management regarding stu | ||||
| > | dy subjects, federal and non-federal sponsors and regulating bodies. - Experience with grant applica | ||||
| > | tion procedures, personnel documentation, contract generation and subcontracting, preferably at UCSF | ||||
| > | . - Certification by the Society of Clinical Research Associates or the Association of Clinical Rese | ||||
| > | arch Professionals | ||||
| 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 | ||||