Sr. Clinical Research Coordinator - Breast Oncology Program

University of California, San Francisco; San Francisco (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

University of California, San Francisco is seeking a Senior Clinical Research Coordinator in the Breast Oncology Program. The role coordinates and oversees the administration of one or more clinical studies, requiring advanced knowledge and leadership of other coordinators and staff.

Reporting to a PI or Director, the position ensures CHR approval and compliance, manages contracts and budgets, and drives enrollment for multicenter trials and investigator-initiated studies within a dynamic

Qualifications

• Bachelor’s degree or equivalent experience in related field.
• Ability to develop recruitment strategies in complex environments.
• In-depth knowledge of clinical research contracts, FDA regulations, and visit structures.
• Project management skills to oversee administrative operations of trials.
• Excellent analytical, interpersonal, verbal and written communication skills.
• Ability to analyze complex issues and provide innovative solutions.
• Ability to operate in a changing organizational/technological environment.
• Ability to assess audit risk and develop project plans to meet deadlines.
• Ability to interpret policies and regulations.
• Financial analysis, budgeting, and projections experience.
• Significant trial management experience or regulatory/compliance responsibilities.
• Experience using database software (MS Access or FileMaker Pro).

Responsibilities

• Coordinate and oversee administration of one or more clinical studies.
• Provide leadership to junior coordinators and support personnel.
• Ensure CHR approval and compliance, contract generation and negotiations.
• Recruit subjects and ensure adequate enrollment for multicenter trials.
• Manage financial oversight and budgeting for studies.
• Collaborate with investigators, clinical staff, HR, contracts and grants, and sponsors.

Skills

Recruitment strategies

Clinical research contracts knowledge

Project management

Analytical skills

Interpersonal and writtenCommunication

Problem solving

Adaptability

Audit risk assessment

Policy interpretation

Financial analysis & budgeting

Trial coordination experience

Database skills (MS Access/FileMaker)

Education

Bachelor’s degree or equivalent experience

Tools

MS Access

FileMaker Pro

Microsoft Excel

Job description

Job Description

Senior Clinical Research Coordinators with the Breast Oncology Program 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.

Senior Clinical Research Coordinators with the Breast Oncology Program 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. 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, human resources, contracts and grants) and elsewhere (industry sponsors, coordinating centers, FDA, NIH), 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 compliance, contract generation, negotiation and approval, subject recruitment, appropriate study testing, and adequate enrollment of multicenter clinical trials, longitudinal cohort studies, local investigator-initiated studies, and biorepository efforts; exercise strong administration and management leadership of clinical research, strong research coordination, and may lead experienced personnel to ensure 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 met and that the programs maintain a reputation for excellence in all activities.

Qualifications

• Bachelor’s degree in related area; 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

Preferred Qualifications

• Two years of experience with breast cancer clinical trial coordination
• 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
• 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