Research Regulatory Specialist II – Research Administration – AdventHealth Orlando
Location Address:800 N. Magnolia Ave., Orlando, FL 32801
Full Time, Days
You Will Be Responsible For:
The Research Regulatory Specialist II, provides regulatory support to the research team by conducting all the tasks and activities of the Research Regulatory Specialist I, and has the additional responsibilities of assisting the Research Regulatory Specialist III to support AdventHealth Research Institute (AHRI) research investigators with investigational new drug (IND), investigational device exemption (IDE), and/or biologics applications to the FDA; and coordination of the regulatory activities for AHRI led multi-site research protocols. The Research Regulatory Specialist II functions as a liaison between the IRB of record for each study protocol, the Food and Drug Administration (FDA), and the investigator, the AHRI study team, other study teams participating in AHRI led multi-site studies, the Sponsor, Contract Research Organization (CRO), Office of Sponsored Programs (OSP), the research Conflicts of Interest (COI) office, the clinical research department Managers and Sr. Managers, and AHRI Leadership. Actively participates in outstanding customer service and accepts responsibility in maintaining relationships that are equally respectful to all.
What You Will Need:
EDUCATION AND EXPERIENCE REQUIRED:
Bachelor’s degree in healthcare related field or biological sciences and at least 2 years work experience in a clinical research setting; OR
Associate Degree and at least 3 years work experience in a healthcare or scientific setting, with at least 2 years in a clinical research setting; OR
Equivalent work consisting of at least five (5) years of experience working in a healthcare or scientific setting, with at least 2 years in a clinical research setting including an institutional review board office, research administration, or regulatory affairs in a pharmaceutical and/or medical device company. Work experience includes documented experience in submitting and maintaining regulatory documents including research essential regulatory documents, conflicts of interest, financial conflicts of interest, and/or ClinicalTrials.gov.
EDUCATION AND EXPERIENCE PREFERRED:
Experience with FDA and/or NIH audits.
Experience in providing research regulatory support in a National Cancer Institute (NCI) designated cancer center.
LICENSURE, CERTIFICATION OR REGISTRATION REQUIRED:
Certification through any professional research organization such as the Society of Clinical Research Associates (SOCRA), Association of Clinical Research Professionals (ACRP), Society of Research Administrators International (SRA), or Public Responsibility in Medicine & Research (PRIM&R)
Knowledge of the research regulatory submission process.
Ability to troubleshoot and appropriately report unexpected problems that may arise during the conduct of clinical trials.
Working knowledge of medical terminology.
Proficient in Microsoft Office applications, Adobe, and internet skills.
Strong verbal and written communication skills including ability to interact with varied professionals.
Strong time management skills and the ability to work independently with attention to detail.
Excellent organizational skills, electronic filing skills, and ability to multi-task performing under aggressive regulatory and/or internal deadlines.
Ability to maintain strict confidentiality of employees, other research team members, patients, research subjects, and institution AdventHealth information, especially related to patient protected health information and disclosed financial information and interests.
KNOWLEDGE AND SKILLS PREFERRED:
Proficient in electronic management systems for research, especially IRBNet, Florence eRegulatory application, and/or Clinical Conductor clinical trials management system (CTMS).
Expertise in AdventHealth Research Institute (AHRI) Institutional Review Board (IRB) policies, procedures, and processes.
Responsible for assisting with the submission of research protocols and other required documents/components to the FDA for AdventHealth held investigational new drug (IND)/investigational device exemption (IDE) or biologics applications.
Provides data and document collection and compilation for regulatory filing with the FDA and other regulatory authorities.
Assists with the technical review and report preparation and submission of FDA required reports of ongoing AdventHealth sponsored and held IND/IDE applications.
Coordinates regulatory processes and submissions for AdventHealth led multi-site research.
Assists Research Regulatory Manager in the orientation of new Research Regulatory Specialists.
Responsible for preparing and submitting new research protocols, protocol amendments, continuing reviews, other study modifications, investigational product updates (investigational brochures and/or device manuals) and ensuring completeness and accuracy of documents while meeting all applicable submission deadlines.
Responsible for preparing and submitting new informed consent documents, revisions to the informed consent, including any required financial disclosure language, and communicating when IRB requires re-consenting of enrolled subjects. Also ensuring all languages of the informed consent requested by the study team are reviewed and approved.
Ensure all regulatory documents, including all Essential Documents as defined by the ICH/GCP guidelines, are in compliance with all applicable Federal regulations, ICH/GCP guidelines, as well as the Association for the Accreditation of Human Research Protection Programs (AAHRPP) standards and all applicable AHRI policies and procedures.
Monitors all required review, approval, and clearance activities for each research protocol maintaining detailed, complete, accurate and current records at the various stages of the process.
Maintains regulatory documents by creating electronic folders in the eRegulatory application, filing them electronically, following standard file name criteria and keeping all documents current per the AdventHealth Orlando SOP 403.002- Florence eRegulatory Essential Document Maintenance, and all Federal, State, and IRB requirements.
Assist in the coordination of sponsor monitoring visits ensuring proper access to eRegulatory files.
Ensures the effective dissemination of all regulatory communications and study updates to investigators, study teams, clinical department managers and senior managers, data managers, the IRB, and all other appropriate research staff to facilitate protocol adherence, patient safety, and regulatory compliance.
Provides timely follow up on requests from IRB, sponsors, study teams, research leadership and administration in a courteous and professional manner.
Ensures regulatory documents for all closed studies are archived and maintained per the applicable regulatory retention period, sponsor requirements, State, IRB, and AHRI policies and procedures.
Facilitates proper and timely research credentialing of all research staff and study team members by maintaining the Research Personnel Log ensuring it is accurate and updated in a timely manner. Also maintaining curriculum vitae’s (CVs), licenses and/or certifications, and documentation of completion of all AHRI and Sponsor mandatory training.
Communicate with COI office confirming if there are any COI Management Plans (MPs) related to each research protocol notifying the study team of all MPs to be implemented.
Confirms with study Sponsor and/or study team if the research protocol is required to be registered on ClinicalTrials.gov, and if required, ensure it is accomplished within the required time period, assisting AHRI investigators and study teams with the registration process when AHRI is the Sponsor.
Supports internal and external auditing and monitoring needs, assisting auditors and making requested documents available for review.
Performs other duties and/or special projects as assigned by Research Regulatory Manager or Director, Office of Research Integrity.
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