Clinical Research Compliance Specialist

University of Florida•Gainesville, FL

5h•$68,000 - $75,000•Onsite

About The Position

The UF Health Cancer Institute is the 72nd NCI designated cancer center and the only one at a public university in the State of Florida. As a matrix cancer center, we span all of the University of Florida's 16 colleges, pulling together a world-class, multi-disciplinary membership of over 350 faculty and 150 staff to address the challenges of the cancer burden faced by the population we serve as we work together to find a cure. As a Clinical Research Compliance Specialist at the UF Health Cancer Institute (UFHCI), you will be responsible for monitoring and auditing clinical trials data to ensure data integrity, protocol compliance, and key regulatory requirements are being followed. Strong understanding of clinical trials coordination, Good Clinical Practice, and the ability to collaborate across multidisciplinary clinical research teams are necessary for success in this role. In your new role you will be responsible for the following: Auditing/monitoring assigned clinical trials and sites, evaluating for compliance with GCP, protocol/regulatory requirements, best practices, and established UFHCI SOPs, documenting and reporting findings, and assisting with the resolution of compliance issues. Preparing for and participating in NCI and Sponsor audits according to established schedules, time-lines, and the request of governing agencies. Working with the rest of the Compliance Team and the Compliance Manager to develop and improve the overall QA program for clinical research at the UFHCI including proposing new procedures, amending and drafting policies, creating tracking systems, and other related tasks. Liaising with study teams, clinical partners, investigators, sponsors, and other relevant parties to provide insight, guidance, education, and to build/improv relationships between the UFHCI and its compliance partners. This is an senior-level position, ideal for candidates with experience in coordinating clinical trials and human subjects research compliance. Employees in these roles operate as part of our collaborative research enterprise and are fundamental to the progress of cancer research being conducted at the University of Florida. A complete job description will be provided to candidates selected for interview.

Requirements

Bachelor's degree in an appropriate area and three years of relevant experience; or an equivalent combination of education and experience.
Bachelor's degree in Nursing, Health Care, Basic Sciences, or related field.
Extensive experience with databases and/or subject data.
Working knowledge of cooperative group clinical trials (with preference for ETCTN and/or NCTN).
Extensive experience with databases and/or subject data.
Proven ability to handle confidential information with discretion, be adaptable to various competing demands, and demonstrate the highest level of customer/client service and response.
Demonstrated ability to establish and maintain effective working relationships with stakeholders and critical staff, both internally and externally, through a variety of communication mediums and venues.
Project manager mindset and basic skills including: delegation, scheduling, communication, critical thinking, task and quality management, risk management, and flexibility.
Proficiency with Microsoft Office suite.
Professional clinical research and/or oncology certification (through SOCRA, ACRP, etc.) are required at the earliest of 12 months from hire or eligibility.

Nice To Haves

Master’s degree in Health Care, Basic Sciences, or related field.
Six to eight years of relevant experience and/or training in research and/or oncology preferred.
Licensure as a registered professional nurse in accordance with Chapter 464 Florida Statutes or eligibility to practice nursing in accordance with Section 210 Florida Administrative Code.
Prior experience in an NCI-designated Cancer Center as a Study Coordinator, Monitor, or Auditor.
Strong interpersonal skills, as well as the ability to work with a broad range of people including investigators, physicians, clinic and hospital staff, sponsors, partners at other institutions, UFHCI staff, and others.
Highly resourceful team-player, with the ability to also be extremely effective, independent, interact professionally, and utilize effective writing and organizational skills.
Forward-thinking mentality, actively seeking opportunities and proposing creative solutions with strong decision-making capability.
Demonstrated understanding and effective use of Emotional Intelligence strategies and skills.
Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment.

Responsibilities

Auditing/monitoring assigned clinical trials and sites, evaluating for compliance with GCP, protocol/regulatory requirements, best practices, and established UFHCI SOPs, documenting and reporting findings, and assisting with the resolution of compliance issues.
Preparing for and participating in NCI and Sponsor audits according to established schedules, time-lines, and the request of governing agencies.
Working with the rest of the Compliance Team and the Compliance Manager to develop and improve the overall QA program for clinical research at the UFHCI including proposing new procedures, amending and drafting policies, creating tracking systems, and other related tasks.
Liaising with study teams, clinical partners, investigators, sponsors, and other relevant parties to provide insight, guidance, education, and to build/improv relationships between the UFHCI and its compliance partners.