Job Description

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 Clinical Research Supervisor, 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.

Responsibilities

of time (Nothing less than 5%)

Essential Function (Yes/No)

Key Responsibilities

(To be completed by Supervisor)

20

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.)

45

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.

5

Yes

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.

15

Yes

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.

10

Yes

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.

• Aid in training for external collaborators on data collection and entry.

5

Yes

Financial Management

This includes but is not limited to:

• 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, may 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.

• May provide input and assist PI in grant development, focusing on budget development.

Qualifications

Required Qualifications:

• BS/BA degree in a 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.

Required Licenses and/or Certifications:

• 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