UCSF

Public health sciences university in San Francisco

Senior Clinical Research Coordinator - Dermatology

Clinical Research OperationsConfirmed live in the last 24 hours

Full-timeSan Francisco, CA, USA$48.78 - $78.50In-person

About the Job

Requirements

A bachelor's degree in a related area, sufficient experience, and demonstrated skills to perform the assigned duties, or equivalent experience and training.
Demonstrated ability to develop recruitment strategies in complex environments and differing patient pools, identify recruitment leads independently, implement new strategies, and continually adjust strategies to meet 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 clinical trials program administration and knowledge of human-subject recruitment strategies.
Analytical skills to evaluate the importance and urgency of problems, plus 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, develop project plans and schedules, and motivate a team to meet deadlines.
Ability to interpret and apply policies and regulations.
Financial analysis skills, including preparing and presenting financial and quantitative analyses, financial projections, and budgets.
Significant project and clinical trial management experience, or progressively responsible experience in a related position that includes regulatory and compliance responsibilities.
Experience using database software such as Microsoft Access or FileMaker Pro.

Responsibilities

Develop project plans, interview key sponsors, and deliver project results.
Provide periodic status reports to project executives and coordinate documentation and archiving of project deliverables.
Design and perform ad hoc performance analysis of projects and project staff.
Build flexible pricing and cost models to test recommended solutions against different outcomes and scenarios in clinical trials and research projects.
Review business processes and operations, and design and implement workflows and controls.
Develop project-related presentation materials for studies.
Monitor operating risks to clinics, physicians, staff, and the University, including inappropriate marketing and poor hiring practices.
Determine groups’ interest in trial participation and assess their ability to execute protocols safely and properly, including infrastructure, staffing, and funding needs.
Negotiate pre-trial agreements and budgets; work with Research Services Analysts and Industry Contracts to execute agreements; set up ancillary departments; train staff; assign tasks; create documentation; and ensure compliance with local and federal research laws.
Provide ongoing staff training, ensure continued compliance, coordinate amendment updates, maintain study files, ensure audit readiness, recruit patients, and track enrollment.
Lead staff in study close-out, discuss subjects’ options, and ensure study-file documentation and storage meet legal requirements.
Maintain systems that ensure compliance with regulatory requirements for safe clinical research and keep all Committee on Human Research documents up to date.
Oversee new Committee on Human Research applications, arrange renewals of existing protocols, respond to requests for revisions, and coordinate protocol changes with sponsors.
Ensure protocol violations are reported to sponsors and adverse events are reported to the Committee on Human Research promptly.
Respond to requests and reviews from sponsors, study monitors, the FDA, and other entities, including complex study-performance audits.
Manage infrastructure for longitudinal cohort studies before and during execution, including databases, space allocation, equipment procurement, and specimen/sample storage and transportation; work with leadership to ensure proper execution.
Manage activities for cohorts and clinical trials across study areas and disciplines.
Collaborate with universities, clinical entities, and industry to use collected data to understand disease progression and predictors.
May contribute to or lead scientific presentations and publications based on collected study data and contribute to new grant proposals.
Protect the University from non-compliance and potential litigation by ensuring contract compliance, adherence to local and federal laws, and compliance with hiring and supervision laws; implement safeguards and regulatory compliance to support audit prevention and success.
Train and educate employees and advise leadership and principal investigators as a regulatory authority and advisor.
Manage audits and help institute and maintain a quality improvement process.
Assist the department with recruiting and training clinical research coordinators in collaboration with leadership.
Guide clinical research coordinators and assistants in recruitment, scheduling, visit management, subject characterization, and data entry.
Train others in federal and local research laws and guidelines, and help manage personnel needs as required.
Oversee budgets, invoices, and reimbursements; ensure billing is accurate and appropriate to avoid improper billing of Medicare, private insurance, or patients.
Guide subjects through financial processes for private and federally funded trials and explain their relationship to insurance reimbursement, ensuring accurate payments and that subjects are not held responsible for trial costs.
Review budget reports monthly; work with the principal investigator to create and maintain annual study budgets, monitor ledger items, and ensure future budget projections match remaining funds.
Ensure research funding is used in accordance with funding-agency protocols.
Assist the principal investigator with grant development, focusing on budget development.

Desired Qualifications

Fluency in spreadsheet software, ability to develop complex spreadsheets independently, and demonstrated skills in audit preparation, execution, and follow-up.
Experience in risk management involving study subjects, federal and non-federal sponsors, and regulatory 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 coordinate with subjects, team members, other departments, and outside institutions; attention to detail; and ability to multi-task in a fast-paced environment with a diverse subject population.
Ability to work independently, complete projects promptly, and prioritize multiple projects to complete essential tasks by deadlines.
Fluency using the Committee on Human Research online iMEDris system to submit, renew, and modify protocols.
Understanding of the patient population to build rapport and determine realistic and appropriate participation.
Experience with electronic medical records.
Knowledge of UCSF and departmental policies for reimbursement, research guidelines, confidentiality, and HIPAA; understanding of UCSF’s research mission and patient-safety and confidentiality procedures for electronic and paper medical records, patient charts, and communications; knowledge of medical terminology, research policies and guidelines, infectious-substance packing and shipping, database building and analysis, and data management using tools such as Access, Stata, SAS, SPSS, and TeleForm programming platforms.
Experience applying Good Clinical Practice Guidelines; the Health Insurance Portability and Accountability Act (HIPAA); the Protection of Human Research Subjects; Committee on Human Research regulations for recruitment and consent; effective cash-handling procedures; Environmental Health and Safety Training; and Fire Safety Training.

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.

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.

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:

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

Key Responsibilities

% of time(Nothing less than 5%)	Essential Function (Yes/No)	Key Responsibilities (To be completed by Supervisor)
30	Yes	Research Operations Management: Develop project plans, interview key sponsors, and deliver tangible project results Provide periodic status reports to project executives and coordinate documentation and archiving of project deliverables Design and perform ad-hoc performance analysis of the projects and the project staff Build flexible pricing and cost models to test recommended solutions against a range of outcomes/scenarios within the clinic trials and research projects Perform business process review, operational reviews and design and implement workflow and controls Develop project-related presentation material for study Monitor key operating potential for risk to clinics, physicians, staff, and the University (e.g., inappropriate marketing, poor hiring practices, etc.)
40	YES	Clinical Trials Management: Determine interest of groups in trial participation, assess ability to execute protocol safely and properly (analysis of infrastructure, staff, funding needs), negotiate pre-trial agreement and budget, work with Research Services Analyst and Industry Contracts to execute agreement, set up ancillary departments, train staff, assign tasks, create documentation, and ensure local and federal research law compliance. Provide ongoing staff training, ensure continued compliance, coordinate amendment updates, maintain study files, ensure audit readiness, recruit patients, and track enrollment; lead staff to ensure proper close-out of studies, discuss subjects’ options, and ensure that documentation and storage of study files meets legal requirements. Ensure optimal systems are in place to ensure compliance with regulatory requirements for the safe conduct of clinical research. Ensure all CHR documents are up to date. Oversee preparation of new CHR applications; arrange paperwork for renewal of existing protocols; respond to CHR requests for revisions; and coordinate protocol changes with study sponsors. Ensure reporting of protocol violations to study sponsors and reporting of adverse events to the CHR in a timely manner. Respond to requests and reviews of studies from sponsors, study monitors, FDA, and other entities, including complex audits of study performance.
10		Longitudinal Cohort Studies: Manage infrastructure before and during study execution, including database management, space allocation, equipment procurement, and specimen/sample storage and transportation; work with leadership to ensure proper execution of studies. Manage activities for cohorts in various areas of studies and disciplines; and for clinical trials in various disciplines. Collaborate with other Universities, clinical entities, and industry using collected data to understand disease progression and predictors. May contribute to or lead scientific presentations and publications based on study data collected. May contribute to the development of new grant proposals.
10		Risk Management: Protect the University from non-compliance and potential litigation by ensuring contract compliance, meeting local and federal laws, and ensuring compliance with hiring and supervision laws; implement safeguards and proper compliance with federal and local regulations to ensure audit prevention and success. Act as regulatory authority and advisor by training and educating employees and advising leadership and PI’s. Manage audits. Help institute and maintain a Quality Improvement Process.
5		HR Management/Administration Assist department with recruit and train clinical research coordinators in collaboration with leadership. Provide guidance to clinical research coordinators and assistants, and help them successfully perform functions including recruitment, scheduling, visit management, subject characterization, and data entry. Train others in federal and local research laws and guidelines. Help manage personnel needs as needed.
5		Financial Management: Oversee budgets, invoices, and reimbursements. Ensure billing is appropriate and accurate to avoid improper billing of Medicare, private insurance, or patients. Guide subjects through financial process (private vs. federal trials and their relationship to insurance reimbursement) to ensure accurate payments are made and subject not held responsible Review budget reports on a monthly basis. Along with the PI, create and maintain the annual study budget, monitoring all items posted on ledgers, and ensuring that future budget projections are consistent with remaining funds. Responsible for ensuring that the use of research funding is in compliance with funding agency protocols. Assist PI in grant development, focusing on budget development.
100%		(To update total %, enter the amount of time in whole numbers (without the % symbol - e.g., 15, 20) then highlight the total sum (e.g., 1%) at the bottom of the column and press F9. The total sum should add up to 100%.)

Budgeted Job Salary Range: 48.78-78.50

About the Company

UCSF

Public health sciences university in San Francisco

UC San Francisco is a public research university in San Francisco focused solely on health sciences, combining professional education with biomedical research and patient care. Its schools of dentistry, medicine, nursing and pharmacy train clinicians and scientists, while teams investigate cancer, immunology, genomics and neuroscience. UCSF Medical Center and Benioff Children's Hospitals connect clinical care with faculty research and training, and university clinics serve patients across Northern California. Founded in 1864, UCSF is the University of California campus dedicated to graduate and professional education and biomedical research, based in San Francisco.

Company size: 10,001+
Company stage: Not listed
Total funding: Not listed
Headquarters: Not listed
Founded: 1864

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