Regulatory Compliance Coordinator II - Cancer Research – Orlando
AdventHealth Orlando seeks to hire Regulatory Compliance Coordinator II who will embrace our mission to extend the healing ministry of Christ.
Located on a lush tropical campus, our flagship hospital, 1,368-bed AdventHealth Orlando, serves as the major tertiary facility for much of the Southeast, the Caribbean and South America. AdventHealth Orlando houses one of the largest Emergency Departments and largest cardiac catheterization labs in the country. We are already one of the busiest hospitals in the nation, providing service excellence to more than 32,000 inpatients and 125,000 outpatients each year.
AdventHealth has a diverse research program, and is actively engaged in research to advance health care and cutting-edge treatments to its patients. There are over 450 open studies across 15 research departments. The Office of Research Administration provides support and safeguards for AdventHealth, investigators, research team members, research subjects, and data to ensure integrity of research at AdventHealth. Operations The Operations Division is involved with all aspects of research study processing and approval, and works closely with AdventHealth's Legal Department to provide research protections to the Hospital and research investigator by reviewing and facilitating the negotiation of research contracts. The Operations Division also works with AdventHealth Research Accounting that is responsible for creating cost accounts, funds tracking and transfers, and the annual A-133 Audit. Grants Management The Grants Management Division facilitates the submission of Federal, State and research grants on behalf of AdventHealth, and provides training, technical assistance, oversight and monitoring to ensure compliance with applicable grantor requirements, and institutional policies. Research Support The Research Support Division is comprised of two components: Compliance and Education and Biostatistical Services. Compliance and Education staff provide training and technical assistance to new investigators with regard to consenting, establishing regulatory binders, and research documentation. Additional responsibilities include conducting on-site audits, providing education and feedback to research teams to improve compliance and good clinical practice, and the maintenance of institutional policies that govern human subjects protection. The Biostatistical Services staff assists researchers with protocol development, study design, and statistical analysis.
Variable - 8 hrs/day
The Research Compliance Coordinator II (CCII) oversees the management of a portfolio of clinical research studies along with departmental systems to support regulatory and compliance requirements in support of research. Manages the onboarding of new studies and coordinates ongoing renewals in support of the required research credentials for physician investigators, research staff, and clinical support staff. Works in a highly independent manner in support of the regulatory compliance oversight of assigned study area, new study activation and ongoing study management. Ensures that every regulatory document submitted to the AdventHealth Institutional Review Board (IRB) or to External Central IRB is in full compliance with the Code of Federal Regulation (CFR), International Conference of Harmonization (ICH) Good Clinical Practice (GCP), and IRB of record policy and procedures. Maintains investigator study files, researches team study training documentation and all essential documents in a FDA compliant (audit ready) manner. Serves as a key centralized informational support resource during all phases of study management for our Physician Investigator, Clinical Research Team, IDS Pharmacists; IRBs and Research Administration. Adheres to all AdventHealth, State of Florida, federal regulations, and guidelines pertaining to HIPAA. Actively participates in outstanding customer service and accepts responsibility in maintaining relationships that are equally respectful to all.
Ability to understand regulatory compliance guidelines and impact if all Federal regulations are not followed in regard to Human subject protection
In-depth knowledge of all necessary requirements to conduct research in regards to Code of Federal Regulation (CFR), International Conference on Harmonization (ICH), Good Clinical Practice (GCP), and the FDA regulations
Motivated, pro-active, organized, able to perform multiple tasks in a timely manner, and works efficiently under pressure with a high proficiency to detail and organization
Ability to lead, provide guidance and provide support to Physician Investigators, Clinical Research teams
Ability to respond rapidly and accurately to the changing needs and regulations of Clinical Research, governmental regulatory requirements and Good Clinical Practice guidelines of the IRB, FDA and AdventHealth Research Administration
Proficient with Microsoft Office applications, navigation and use of web portals, as well as use of electronic document management
Effective written and verbal communication skills for problem solving, team building and negotiation
Proficient working knowledge of medical terminology and specific understanding of cancer, treatment and clinical trial operations
Knowledge of FH IRB and central/external IRB procedures and policies(Perferred)
Bachelor's degree in Health Science
Two years of experience in a clinical practice or other healthcare related setting
Master's degree in a healthcare related program (Preferred)
Licensure, Certification, or Registration Required:
Active Clinical Research Professional certification (Preferred)
Demonstrates through behavior AdventHealth's Core Values of Keep Me Safe, Love Me, Make it Easy, and Own it as outlined in the organization's Performance Excellence Program.
Demonstrates, through behavior, AdventHealth's core values of Integrity, Compassion, Balance, Excellence, Stewardship, and Teamwork.
Performs a variety of duties related to the oversight and management of compliant research studies. Understands and communicates to research teams the basics of research study design, randomization, phase, disease site, line of therapy and required study parameters/events. Ensures accuracy in the completion and proper timeline of all documents in support of IRB submission and review. Monitors work volume and turn-around time during all phases of study management to ensure adherence to research standards and productivity targets are achieved.
Works closely with the Research Director and Physician Investigators to review and evaluate all new studies to ensure feasibility and priority. Coordinates, and participates with research-required regulatory meetings such as pre-site selection visits, site initiation visits, routine monitor visits; sponsor routine audits, and ad-hoc quality assurance audits for all pharmaceutical and NCI sponsored trials. Ensures updated correspondence with the IRB of record and takes independent initiative to address and resolve issues during all visits.
Acts as a liaison and institutional point of contact between all external study Sponsor Representatives, the Physician Investigators, Research Clinical teams, Investigational Drug Pharmacy team, and departmental and Research Administration in order to ensure compliance with all federal regulations and FDA guidance in regard to compliant conduct of Human Subjects research. External study sponsors are the primary customers and include (but are not limited to) the National Cancer Institute, Pharmaceutical Companies, Clinical Research Organizations, External IRBs, Biosafety Committees and the FDA. Maintains the departmental regulatory database that contains data to track key study details and milestones to ensure compliance for IRB and Biosafety committees in support of amendments, annual renewals, informed consent versions, and Physician Investigator workload.
Ensures all Physician Investigators, Clinical Research Team and IDS pharmacy have the proper study documents, forms, and manuals for compliant study coordination. Coordinates and attends sponsor required meetings with Physician Investigators, Clinical Research Team and IDS Pharmacy to provide study status updates and facilitate educational and study training sessions required by study sponsors. Completes the required documents for research studies to ensure regulatory compliance with processing amendments, internal/external audits, serious adverse events, deviations, and annual reporting ensuring timeliness and accuracy of content and volume data.
Reviews weekly and monthly Sponsor Regulatory Web Portals and NCI/Pharmaceutical web-published protocol updates and study status.
Works closely with the Research Director to ensure proper research compliance is maintained and all documents are submitted to the IRB in accordance with state, and federal regulations. Collects, reviews, maintains and updates required clinical laboratory certification and state license documents, physician medical license and CVs, researches staff resumes, certificates of all required research training. Key contact for all new physician and non-physicians who are engaged in research activities to ensure obtainment of all required documents and completed training. )
Ensures ongoing and accurate communication of study status and study key events and timelines to Physician Investigators, Clinical Research team and IDS Pharmacy team. Disseminates in a professional verbal and written manner study regulatory communications and pertinent study information to ensure safe and compliant patient care as it relates to requirements of research studies. Responsible for updating departmental listings of studies to ensure accuracy of listings which are posted on web and disseminated to physician offices.
Working with Director, assesses and evaluates the needs of research department to cultivate a climate of compliance at the highest level that meets all research requirements, through training, education and strategic planning. Assists with collection and tracking of billable events to study sponsors. Maintains productivity tracking document as assigned by Director.
Contributes to providing efficient customer service by maintaining open and professional written and verbal communication with all physician investigators, clinical research and IDS pharmacy staff. Actively participates in inter-departmental discussions relevant to evaluation and review of clinical research studies, document maintenance and efficient work policy and procedures.
Performs other duties as assigned or directed by the Director to ensure the efficient and cost effective operation of the department.
If you want to be a part of a team that is dedicated to delivering the highest quality in patient care, we invite you to explore the Research Compliance Coordinator II opportunity with AdventHealth Orlando and apply online today.
AdventHealth Greater Orlando (formerly Florida Hospital) is one of the largest faith-based health care providers in the United States. For 150 years, we have carried on a tradition of providing whole-person care that not only addresses patients' physical ailments, but also supports their emotional and spiritual well-being. We demonstrate the same level of compassion and care for our employees as well, doing all that we can to help them realize their full potential – both personally and professionally.