Sr. Clinical Research Coordinator - Dermatology

University of California, San Francisco

San Francisco (CA)

On-site

USD 120,000 - 170,000

Full time

13 hours ago

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Job summary

UCSF Health, AG seeks a Senior Clinical Research Coordinator to independently coordinate administrative operations for one or more clinical studies.

The role requires leadership, advanced knowledge of trials, FDA regulations, and effective collaboration with investigators, staff, sponsors, and regulatory bodies to ensure compliance and enrollment goals.

Qualifications

Bachelor's degree in related area and relevant experience
Strong ability to recruit in complex environments
Deep knowledge of contracts, grants, clinical trials, protocols, FDA regulations
Proven project management for trials administration
Excellent analytical and communication skills
Ability to manage audits and risk
Ability to interpret policies and apply regulations
Financial analysis skills for budgets and projections
Extensive clinical trial management experience
Experience with database software like MS Access or FileMaker Pro

Responsibilities

Coordinate and manage administrative operations of clinical trials
Lead and mentor other coordinators and staff
Ensure CHR approval, contracts, recruitment, and enrollment
Oversee safety, compliance, budgets, and regulatory needs
Collaborate with clinicians, sponsors, and HR on trials

Skills

Recruitment strategies

Contract & grants knowledge

Project management

Analytical thinking

Interpersonal communication

Audit risk assessment

Policy interpretation

Financial analysis

Team leadership

Database familiarity

Education

Bachelor's degree in related area

Tools

MS Access

FileMaker Pro

Job description

Job Summary

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.

Job Description

Job Summary

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.

Department Overview: Overview

The Department of Dermatology, School of Medicine, is responsible for a broad range of patient care, teaching, research and public service responsibilities.The Department provides medical students, residents, and post-doctoral fellows in the School of Medicine, with programs in research, patient care, teaching and public service.The Department is comprised of four distinct clinical sub-units located at the Ambulatory Care Center, San Francisco General Hospital, Mount Zion, Mission Bay and the Veteran’s Administration Medical Center and consists of 38 full-time faculty, 40 researchers, 40 staff, 13 residents and 6 clinical fellows.These operations are administered through various sites, interdependent sub-units, which are coordinated through a centralized Administrative Core.

Qualifications

Required Qualifications:

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.

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
Attention to detail; strong interpersonal skills; excellent, effective verbal and written communication skills to coordinate with subjects, team members, other departments and outside institutions; and the ability to multi-task in a fast-paced environment while working with a diverse subject population.
Ability to work well independently, complete projects in a timely manner, and prioritize multiple projects to ensure the completion of essential tasks by deadlines.
Fluency in the usage of Committee of Human Research (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 with electronic medical records.
Knowledge of UCSF and departmental policies for dealing with reimbursement, guidelines for research, confidentiality and HIPPA regulations, following the UCSF mission statement and purpose for research, and a clear understanding of policies and procedures on patient safety and confidentiality (electronic and hard copy medical records, patient charts, communication, etc.); knowledge of medical terminology, research policies and guidelines, guidelines for packing/shipping infectious substances, database building/analysis, and data management within some of the following:Access, Stata, SASS/ SPSS, and Teleform programming platforms.
Experience applying the following regulations and guidelines: