SR Clinical Research Coordinator

Job Summary

Senior Clinical Research Coordinators with the Cutaneous Oncology program 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 the overall operational management of clinical research activities, implementing a diverse portfolio of research activities for one or more studies that may include multicenter clinical trials, local investigator‑initiated trials, and programmatic activities such as a clinical database and biorepository.

• 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).

• 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.

• 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.

• 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 PIs.
• Manage audits.
• Help institute and maintain a Quality Improvement Process.

• Oversee budgets, invoices, and reimbursements.
• Ensure billing is appropriate…