Sr. Clinical Research Coordinator - Breast Oncology Program

% 

of time  (Nothing less than 5%)

Essential Function (Yes/No)

Key Responsibilities

10

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.)

50

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

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.

5

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.

25

HR Management/Administration

• Assist with recruitment; train clinical research coordinators in collaboration with leadership. 
• Mentor clinical research coordinators and assistants, and help them successfully perform functions including recruitment, scheduling, visit management, subject characterization, and data entry. 
• Train in federal and local research laws and guidelines.
• Help manage personnel needs.

5

Yes

Financial Management:

• Monitor 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%