Date Posted:

2025-05-08

Country:

United States of America

Location:

Sarasota Cattlemen Office

WHY JOIN FCS

At Florida Cancer Specialists & Research Institute, we believe our people are our strength and we invest in them. In addition to having a positive impact on the people and communities we serve, associates benefit from significant professional opportunities, career advancement, training and competitive wages.

Offering competitive salaries and comprehensive benefits packages to include tuition reimbursement, 401-K match, pet and legal insurance.

A LITTLE BIT ABOUT FCS

Since 1984, Florida Cancer Specialists & Research Institute & Research Institute (FCS) has built a national reputation for excellence.  With over 250 physicians, 220 nurse practitioners and physician assistants and nearly 100 locations in our network.  Utilizing innovative clinical research, cutting-edge technologies, and advanced treatments, we are committed to providing world-class cancer care.  We are recognized by the American Society of Clinical Oncology (ASCO) with a national Clinical Trials Participation Award, FCS offers patients access to more clinical trials than any private oncology practice in Florida. Our patients have access to ground-breaking therapies, in a community setting, and may participate in national clinical research studies of drugs and treatment protocols. In the past five years, the majority of new cancer drugs approved for use in the U.S. were studied in clinical trials with FCS participation prior to approval.

Through our partnership with Sarah Cannon, we are one of the largest clinical research organizations in the United States. Often, FCS leads the nation in initiating research studies and offering ground-breaking new therapies to patients.

Come join us today!

Primary Key Performance Areas

KPA 1 – Creates and maintains central regulatory files in accordance with site SOP.

• Adhere to and maintain working knowledge of FCS practice policies, the Federal regulations, ICH, and GCP guidelines.
• In compliance with the Code of Federal Regulations under the Health Insurance Portability and Accountability Act (HIPAA), assure that patient records will be kept confidential and secure.
• Collect and maintain study specific documentation in the appropriate Regulatory Binder as well as the electronic document system including:
  • Create and maintain the FCS Research Delegation of Authority logs and role specific profiles, ensure revised profiles to investigators and research staff as roles and responsibilities necessitate.
  • Create and maintain study-specific FDA Form 1572, ensure form is reconciled and updated as change necessitates.
  • Collect and maintain Financial Disclosure Forms as completed by investigators, escalate reported disclosures to leadership if reported.
  • In collaboration with various departments, maintain historical credentials all current and previous Investigators and research staff, laboratory licenses, CLIA/COLA. Produce as needed for Sponsor/CRO review.
• Maintain credible documentation by using ALCOAC method (Attributable, Legible, Contemporaneous, Original, Accurate, Complete).
• Support GCP and protocol specific training for staff and investigators by:
  • Upload and archive protocol specific training modules for all studies.
  • According to site SOP, distribute training module assignments and maintain documentation GCP training for all research staff and investigators.

KPA 2 – Ensure completion, submission and subsequent distribution of IRB approved documents in accordance with site SOP.

• Prepare and ensure timely reporting and submissions to IRB in accordance to site SOP and federal regulations including:
  • Ensure IRB approval is obtained at study activation and maintain in the Regulatory Binder
  • Obtain documentation of IRB approvals, including amendments and revision to study related documents, such as revised informed consents and protocols and maintain in the Regulatory Binder.
  • Complete the IRB Continuing review reports required by the IRB and submit to the applicable IRB. File all correspondence regarding continuing review report submission in the Regulatory Binder.
  • Ensure the process is followed for reporting any Serious Adverse Event (SAE) to the IRB that meets IRB reporting guidelines, as determined by the PI.
• Notify the Research Coordinators via email when a new/amended Protocol or ICF has been IRB ap