Research Regulatory Affairs Speciallist

Florida Cancer Specialists•Fort Myers, FL

6d•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 within the organization's clinical research operations. The specialist will be responsible for creating and maintaining central regulatory files, ensuring adherence to site SOPs, Federal regulations, ICH, and GCP guidelines. A key aspect of the role involves maintaining patient record confidentiality and security in compliance with HIPAA. The position requires meticulous attention to detail in managing study-specific documentation, including FDA Form 1572, investigator credentials, and laboratory licenses. The specialist will also support staff and investigator training on GCP and protocol specifics. Furthermore, the role involves managing IRB submissions, amendments, continuing reviews, and reporting of serious adverse events. Effective management of monitoring and audit activities, including preparation for visits, addressing discrepancies, and ensuring timely resolution of issues, is essential. The specialist will also be involved in study termination and closeout activities, as well as preparing for internal and external audits. This position offers opportunities for professional growth and competitive compensation within a leading cancer research organization.

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 and responsibilities necessitate.
Creates and maintains study-specific FDA Form 1572, ensuring reconciliation and updates as changes occur.
Collects and maintains Financial Disclosure Forms from investigators and escalates reported disclosures to leadership.
Maintains historical credentials for all current and previous Investigators and research staff, laboratory licenses, CLIA/COLA in collaboration with various departments.
Produces documentation as needed for Sponsor/CRO review.
Maintains credible documentation using the ALCOAC method (Attributable, Legible, Contemporaneous, Original, Accurate, Complete).
Supports GCP and protocol-specific training for staff and investigators by uploading and archiving protocol-specific training modules.
Distributes training module assignments according to site SOP and maintains documentation of GCP training for all research staff and investigators.
Ensures completion, submission, and subsequent distribution of IRB-approved documents in accordance with site SOP.
Prepares and ensures timely reporting and submissions to IRB in accordance with site SOP and federal regulations.
Ensures IRB approval is obtained at study activation and maintains it in the Regulatory Binder.
Obtains documentation of IRB approvals, including amendments and revisions to study-related documents, and maintains them in the Regulatory Binder.
Completes IRB Continuing Review reports required by the IRB and submits them to the applicable IRB.
Files all correspondence regarding continuing review report submissions in the Regulatory Binder.
Ensures the process for reporting Serious Adverse Events (SAE) to the IRB that meet reporting guidelines is followed.
Notifies Research Coordinators via email when a new/amended Protocol or ICF has been IRB approved.
Ensures research coordinators are provided IRB instructions for reconsenting subjects in a timely manner.
Reviews signed ICFs for completeness and notifies the Research Coordinator of any discrepancies.
Maintains an internal log of consent versions.
Maintains a master subject/enrollment list electronically for each study until termination and records are ready for archiving.
Effectively manages monitoring and audit activities according to site SOP.
Conducts on-site and remote monitoring activities.
Prepares for interim monitoring visits (IMV) by ensuring the Regulatory Binder is complete prior to the visit.
Works collaboratively with the Sarah Cannon Regulatory Department to correct any noted discrepancies during monitoring visits.
Requests that the monitor summarize findings, issues, or concerns during the visit in a follow-up letter and notes the status of resolution.
Meets with the Sponsor representative as needed during visits to ensure issues are resolved appropriately and in a timely manner.
Maintains the Site Visit Log and ensures monitors complete the log prior to departure.
Reviews monitor reports/letters following the IMV and forwards them to appropriate staff for review.
Ensures all identified issues are addressed prior to the next monitoring visit.
Maintains a copy of the letters in the Regulatory Binder.
Schedules, prepares, and conducts the Study Termination Visit.
Ensures all study documents are filed and discrepancies are addressed prior to the scheduled Study Termination Visit.
Sends required documents to Sarah Cannon and ensures all electronic documents and reporting systems are final signed.
After study closure and all queries are resolved, ensures files are packaged and archived.
Prepares for internal and external audits by retrieving all documents and ensuring all study-related documents are complete prior to the audit.
Performs other duties and projects as assigned.