The Senior Clinical Research Coordinators (Sr. CRC) with the Clinical Research Network Office independently coordinate and are accountable for the overall administration and conduct of one or more clinical studies, typically requiring advanced-level knowledge and skills. They may provide leadership to lower-level clinical research coordinators and/or other support personnel. The position is responsible for, and critically important to the overall operational management and conduct of clinical re... more details
The Senior Clinical Research Coordinators (Sr. CRC) with the Clinical Research Network Office independently coordinate and are accountable for the overall administration and conduct of one or more clinical studies, typically requiring advanced-level knowledge and skills. They may provide leadership to lower-level clinical research coordinators and/or other support personnel.
The position is responsible for, and critically important to the overall operational management and conduct of clinical research activities. It has direct responsibility 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 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, Institutional Review Board (IRB), human resources, contracts and grants) and elsewhere (industry sponsors, coordinating centers, FDA, NIH), exhibiting an in-depth knowledge of specific programs.
Reporting to the Clinical Research Manager (CRM), the incumbent may assist with completing pre-activation tasks such as feasibility surveys and assessment with study team, coordinate protocol reviews and submissions to Disease Site Committee and Protocol Review Committee. 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. A central responsibility for assisting with and ensuring IRB approval and compliance, subject recruitment, appropriate study testing, study coordination, data entry and management, and adequate enrollment of multicenter clinical trials, longitudinal cohort studies, local investigator-initiated studies, and biorepository efforts; exercise strong administration, organizational, multitasking, communication, both written and spoken, management leadership of clinical research and strong research coordination.
This is a position of leadership whose main purpose is to ensure that clinical research commitments are met and that the programs maintain a reputation for excellence in all activities.
Note: This position requires a physical/health screening.
The final salary and offer components are subject to additional approvals based on UC policy.
To see the salary range for this position (we recommend that you make a note of the job code and use that to look up): TCS Non-Academic Titles Search (https://tcs.ucop.edu/non-academic-titles)
Please note: An offer will take into consideration the experience of the final candidate AND the current salary level of individuals working at UCSF in a similar role.
For roles covered by a bargaining unit agreement, there will be specific rules about where a new hire would be placed on the range.
To learn more about the benefits of working at UCSF, including total compensation, please visit: https://ucnet.universityofcalifornia.edu/compensation-and-benefits/index.html
Experience in clinical research or demonstrated research or training experience that translates into a clinical research settingPrior experience with various computer programs (Microsoft Office; internet-based databases) and using specialized software such as OnCore.
Fluency in spreadsheet software; ability to develop complex spreadsheets independently; demonstrated skills in audit preparation, execution, and follow-up.
Experience in risk management regarding study subjects, federal and non-federal sponsors and regulating bodies.
Experience with grant application procedures, personnel documentation, contract generation and subcontracting, preferably at UCSF.
Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals
Fluency in the usage of Committee of Human Research Preferred (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 applying the following regulations and guidelines: Good Clinical Practice Guidelines, Health Information and Accountability Act (HIPAA), The Protection of Human Research Subjects, CHR regulations for recruitment and consent of research subjects, Effective Cash Handling Procedures, Environmental Health and Safety Training, Fire Safety Training
Working knowledge of federal, state, and local research regulations and guidelines, and research practice methods in a laboratory or clinical setting
Ability to apply it to the assessment, interpretation, and processing of medical data
Prior analytical and writing skills in a science/research environment
Knowledge of clinical research in oncology.
Knowledge and experience in managing oncology clinical trials
Bachelor’s degree in related area and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities and/or equivalent experience/training.
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.
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 demonstrated interpersonal, verbal and written communication skills.
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 interpret and apply policies and regulations.
Financial analysis skills; demonstrated skills in preparing and presenting financial and quantitative analyses, including financial projections and budgets.
Significant project 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.
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