Research Regulatory Affairs Specialist I

Florida Cancer Specialists•West Palm Beach, FL

1d•Hybrid

About The Position

At Florida Cancer Specialists & Research Institute (FCS), 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. FCS has built a national reputation for excellence since 1984, with over 250 physicians, 220 nurse practitioners and physician assistants, and nearly 100 locations. We utilize innovative clinical research, cutting-edge technologies, and advanced treatments to provide world-class cancer care. FCS offers patients access to more clinical trials than any private oncology practice in Florida, including ground-breaking therapies and national clinical research studies. Through our partnership with Sarah Cannon, we are one of the largest clinical research organizations in the United States, often leading the nation in initiating research studies and offering new therapies.

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.
Prior clinical research experience is preferred but not 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.
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.
Ensures 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 revised profiles are updated as roles and responsibilities necessitate.
Creates and maintains study-specific FDA Form 1572, ensuring reconciliation and updates as changes necessitate.
Collects and maintains Financial Disclosure Forms as completed by investigators, escalating reported disclosures to leadership if reported.
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, distributing training module assignments, and maintaining documentation of GCP training.
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 maintained 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 and submits IRB Continuing Review reports to the applicable IRB and files all correspondence regarding these submissions.
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 internal log of consent versions.
Maintains a master subject/enrollment list electronically for each study until termination and records are ready for archiving.
Conducts on-site and remote monitoring activities.
Prepares for interim monitoring visits (IMV) by ensuring the Regulatory Binder is complete prior to the visit.
Collaborates with the Sarah Cannon Regulatory Department to correct any noted discrepancies during monitoring visits.
Requests monitors to summarize findings, issues, or concerns in a follow-up letter and notes the status of resolution.
Meets with Sponsor representatives as needed during visits to ensure issues are resolved appropriately and in a timely manner.
Maintains the Site Visit Log and ensures monitors complete it prior to departure.
Reviews monitor reports/letters following IMV and forwards them to appropriate staff for review.
Ensures all 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 the Study Termination Visit.
Sends required documents to Sarah Cannon and ensures all electronic documents and reporting systems are final signed.
Packages and archives files after study closure and resolution of all queries.
Prepares for internal and external audits by retrieving documents and ensuring all study-related documents are complete.
Performs other duties and projects as assigned.