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AI Summary
The Senior Clinical Research Coordinator independently manages the administration and operational activities of clinical studies, including multicenter trials and investigator-initiated research. They are responsible for implementing recruitment strategies, ensuring regulatory compliance, and providing leadership to support personnel.
Please note: This is a limited appointment with 18 months duration. Senior Clinical Research Coordinators independently coordinate and are accountable for the overall administration 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 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.
Required Qualifications
- BS/BA degree in a related area and/or equivalent experience/training. Sufficient experience and demonstrated skills to perform the assigned duties and responsibilities.
- Sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities.
- 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 REDCap or Medidata RAVE or other electronic data capture system.
- 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.
Preferred Qualifications
- 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.
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