Senior Clinical Research Coordinator

UCSF Health; San Francisco (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

UCSF Health is seeking a Senior Clinical Research Coordinator (limited 18-month appointment) to independently manage the administrative operations of one or more clinical studies. You will lead junior staff, coordinate multicenter NIH and industry trials, and drive recruitment strategies to meet complex goals.

The role requires extensive knowledge of FDA regulations, contracts, and budgeting, with strong analytical and communication skills to adapt in a dynamic research environment and ensure

Qualifications

• BS/BA or equivalent experience with ability to perform duties.
• Experience and skills to independently manage assigned tasks.
• Ability to develop recruitment strategies in complex environments and adjust to meet goals.
• In-depth knowledge of clinical research contracts, trials, FDA regulations, and visit structures.
• Project management to oversee administrative operations of trials.
• Strong analytical, written, and verbal communication skills.
• Ability to operate in changing organizational and technological environments.
• Ability to assess audit risk and develop project plans to meet deadlines.
• Understanding of policies and regulations and financial analyses.
• Experience with trial management and regulatory/compliance responsibilities.

Responsibilities

• Coordinate and manage the administrative operations of one or more clinical studies.
• Provide leadership to junior coordinators and support personnel.
• Implement a diverse portfolio of research activities, including multicenter trials.
• Develop recruitment strategies and monitor progress against goals.

Skills

Recruitment strategies

Project management

Analytical skills

Interpersonal communication

Audit risk awareness

Policy interpretation

Financial analysis

Budgeting

Team leadership

Problem solving

Education

BS/BA in related field

CRP/ACRP certification within 1 year

Tools

REDCap

Medidata RAVE

Electronic Data Capture (EDC)

Job description

Job Description

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.

License/Certification

• 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.