Research Regulatory Affairs Speciallist

Florida Cancer Specialists & Research Institute•Fort Myers, FL

4d•Hybrid

About The Position

Florida Cancer Specialists & Research Institute (FCS) is seeking a Regulatory Affairs Specialist to join their team. This role is crucial for maintaining regulatory compliance, managing study documentation, and supporting research activities. The specialist will be responsible for creating and maintaining central regulatory files, ensuring adherence to site SOPs, federal regulations, ICH, and GCP guidelines. They will also play a key role in managing IRB submissions, monitoring activities, and preparing for audits. FCS is a leading oncology practice known for its excellence in cancer care, innovative clinical research, and access to groundbreaking therapies. Joining FCS means contributing to a mission of providing world-class cancer care while benefiting from professional growth opportunities and a competitive compensation and benefits package.

Requirements

High school education required.
Valid state Driver’s License for travel to satellite offices and offsite meetings.
Compliance with the company Driver Safety Operations and Motor Vehicle Records Check Policy is required.
Critical thinking skills including solid problem solving, analysis, decision-making, planning, time management and organizational skills.
Must be detailed oriented with the ability to exercise independent judgment.
Developed interpersonal skills, emotional intelligence, diplomacy, tact, conflict management, delegation skills, and diversity awareness.
Ability to work effectively with sensitive and confidential material and sometimes emotionally charged matters.
Good command of the English language.
Effective communication skills (oral, written, presentation), is an active listener, and effectively provides balanced feedback.
Strong customer focus.
Ability to build an engaging culture of quality, performance effectiveness and operational excellence through best practices, strong business and political acumen, collaboration and partnerships, as well as a positive employee, physician and community relations.
Effectively manages own time, conflicting priorities, self, stress, and professional development.
Self-motivated and self-starter with ability work independently with limited supervision.
Ability to work remotely effectively as required.
Must be able to work effectively in a fast-paced, multi-site environment with demonstrated ability to juggle competing priorities and demands from a variety of stakeholders and sites.
Proficiency in MS Office Word, Excel, Power Point, and Outlook expected.

Nice To Haves

Bachelors’ degree in Biological Science, Social Sciences, English, or other related field preferred.
Prior clinical research experience is preferred but not required.
Second language is an asset but not required.

Responsibilities

Creates and maintains central regulatory files in accordance with site SOP.
Adheres to and maintains working knowledge of FCS practice policies, Federal regulations, ICH, and GCP guidelines.
Assures patient records are kept confidential and secure in compliance with HIPAA.
Collects and maintains study-specific documentation in the appropriate Regulatory Binder and electronic document system.
Creates and maintains FCS Research Delegation of Authority logs and role-specific profiles, ensuring updates as roles change.
Creates and maintains study-specific FDA Form 1572, ensuring reconciliation and updates.
Collects and maintains Financial Disclosure Forms from investigators and escalates reported disclosures to leadership.
Maintains historical credentials for investigators and research staff, laboratory licenses, and CLIA/COLA in collaboration with various departments.
Supports GCP and protocol-specific training for staff and investigators by uploading and archiving training modules, distributing assignments, and maintaining documentation.
Ensures completion, submission, and distribution of IRB-approved documents in accordance with site SOP.
Prepares and ensures timely reporting and submissions to the IRB.
Obtains and maintains IRB approval documentation, including amendments and revisions to study-related documents.
Completes and submits IRB Continuing Review reports.
Files all correspondence regarding continuing review report submissions.
Ensures the process for reporting Serious Adverse Events (SAE) to the IRB is followed.
Notifies Research Coordinators of new/amended Protocol or ICF IRB approvals and provides instructions for re-consenting subjects.
Reviews signed ICFs for completeness and notifies Research Coordinators of discrepancies.
Maintains internal log of consent versions.
Maintains a master subject/enrollment list electronically for each study.
Conducts on-site and remote monitoring activities.
Prepares for interim monitoring visits (IMV) by ensuring the Regulatory Binder is complete.
Collaborates with the Sarah Cannon Regulatory Department to correct discrepancies noted during monitoring visits.
Requests monitors to summarize findings and ensures resolution.
Meets with Sponsor representatives as needed to resolve issues.
Maintains the Site Visit Log.
Reviews monitor reports/letters and forwards them to appropriate staff.
Ensures identified issues are addressed prior to the next monitoring visit.
Schedules, prepares, and conducts Study Termination Visits.
Ensures all study documents are filed and discrepancies are addressed prior to termination visits.
Sends required documents to Sarah Cannon and ensures electronic documents and reporting systems are final signed.
Packages and archives files after study closure and query resolution.
Prepares for internal and external audits by retrieving documents and ensuring completeness.
Performs other duties and projects as assigned.