Martha Docteur
Miami,FL
Summary
Experienced Regulatory Coordinator with expertise in managing regulatory documents for clinical studies, ensuring compliance with protocols, SOPs, and GCP. Collaborates with cross-functional teams to improve project outcomes and uphold quality standards in clinical research while maintaining accurate documentation and study readiness.
Overview
16
16
years of professional experience
Work History
Regulatory Coordinator
Segal Trials Services
Miami Lakes, USA
02.2024 - Current
- Completes and maintains regulatory documents for clinical studies/trials to ensure protocol, regulatory and Standard Operating Procedures (SOP) and Good Clinical Practice (GCP) compliance.
- Notified administration, regulatory, recruitment, and study team, including PI, of receipt and submission of regulatory documents to maintain compliance.
- Request list of staff to be included as sub-investigators on 1572 from study coordinator.
- Request answers to questions from CRO/Sponsor (see attachment) prior to completion of documents.
- Prepare and submit regulatory documents to CRO/IRB.
- Filed regulatory documents in Clinical Trial Management System (CTMS) before site activation and updated Regulatory Checklist to ensure readiness.
- Obtain study advertising materials from other studies with same indication and submit to advertising director for approval prior to submission of initial regulatory document.
- Save ads (submission and IRB approval) under the study.
- Obtain subject stipend/compensation from contract department.
- Review initial IRB approved consent form to ensure accurate information such as site address (if applicable), office and emergency phone numbers, and compensation.
- Review all tabs in the regulatory binder and make copy of documents for study coordinators as applicable to their study.
- Create hospital/facility manual for study and provide administrator with the manual at satellite site.
- Create study contact sheet for each study and complete section as applicable.
- Create and maintain a consent log under each study.
- Ensure regulatory binders are logged out and signed in according to SICR SOPs.
- Follow procedures pertaining to each study as applicable to department.
- Maintain regulatory binders for each study.
- Create 'Correspondence Binder' as part of regulatory binders for each study.
- Update binders throughout the duration of study until study close-out.
- Follow other SICR SOPs as pertaining to regulatory affairs.
- Collaborated with clinical research coordinator to resolve issues identified during monitor’s visit, facilitating smooth study operations.
- Provide copy of protocol amendment and revised investigator drug brochure (IDB) after IRB approval.
- Notify site by e-mail when amendment is received and file under study.
- Notify site by e-mail when amendment is IRB approved and attach copy of approved documents along with amendment.
- Notify site to train team on amendment and provide regulatory department with copy of training document for filing after receipt of IRB approved amendment, informed consent form, if applicable, and request in-patient sites to provide copy to hospital administrator for their manual.
- Ensure documents are filed in binders before monitor’s visits.
- Maintain current knowledge of regulatory affairs and/or issues.
- Attend Study Initiation Visit (SIV) and Close Out Visit (COV).
- Archive documents for study per SICR SOPs.
- Create and maintain SICR staff CVs.
- May perform other duties not specifically listed in this job description as assigned by their immediate supervisor.
- Segal Trials is a private medical research business providing services in the field of Hospital and Health throughout South Florida and South Carolina.
Regulatory Affairs Analyst
University of Miami School of Medicine
Miami, FL
01.2024 - 06.2025
- Completes and maintains regulatory documents for clinical studies/trials to ensure protocol, regulatory and Standard Operating Procedures (SOP) and Good Clinical Practice (GCP) compliance.
- Notified administration, regulatory, recruitment, and study team, including PI, of receipt and submission of regulatory documents to maintain compliance.
- Request list of staff to be included as sub-investigators on 1572 from study coordinator.
- Request answers to questions from CRO/Sponsor (see attachment) prior to completion of documents.
- Prepare and submit regulatory documents to CRO/IRB.
- Filed regulatory documents in Clinical Trial Management System (CTMS) before site activation and updated Regulatory Checklist to ensure readiness.
- Obtain study advertising materials from other studies with same indication and submit to advertising director for approval prior to submission of initial regulatory document.
- Save ads (submission and IRB approval) under the study.
- Obtain subject stipend/compensation from contract department.
- Review initial IRB approved consent form to ensure accurate information such as site address (if applicable), office and emergency phone numbers, and compensation.
- Review all tabs in the regulatory binder and make copy of documents for study coordinators as applicable to their study.
- Create hospital/facility manual for study and provide administrator with the manual at satellite site.
- Create study contact sheet for each study and complete section as applicable.
- Create and maintain a consent log under each study.
- Ensure regulatory binders are logged out and signed in according to SICR SOPs.
- Follow procedures pertaining to each study as applicable to department.
- Maintain regulatory binders for each study.
- Create 'Correspondence Binder' as part of regulatory binders for each study.
- Update binders throughout the duration of study until study close-out.
Team Administrator / Project Coordinator
Covance Laboratory Services
Indianapolis, USA
04.2021 - 10.2021
- Provided administrative support to CTTS and collaborated with Covance departments to ensure accurate site information was loaded in Zavacor using the Workfront tool.
- Coordinated global communication with Covance CTTS units to align on service definitions and changes for global processes.
- Assist and support management in the implementation of global processes and procedures.
- Work with management and/or designated team members to ensure prioritization of the tasks linked to the defined responsibilities.
- Manage day-to-day tasks related to the departmental internal communication.
- Contributed to team planning tasks and resolved departmental issues to enhance operational efficiency.
- Support a culture of continuous improvement, quality and productivity.
- Adhere to management communications, meetings, Standard Operating Procedures (SOPs), and other documents effectively and in a timely manner.
- CRA update in our database: checking Zavacor to see if all sites have a CRA, checking public folders to get CRA updated.
- IS escalation for query resolution: helping IS team and RSC by finding contact either via XIP user or via public folders and updating Zavacor when contact is the best SC on site for query resolution.
- Covance is a drug development service company that through unique perspective and precision delivery, has helped bring 49 of the top 50 best-selling drugs on the market today from potential into reality.
Elementary School Teacher 1st grade
BridgePrep Academy Elementary School
Hollywood, USA
11.2017 - 06.2020
- Hired as a full-time teacher following student teaching practicum, instructing all academic subject areas to classrooms of up to 28 1st and 2nd grade students.
- Received high marks for classroom teaching and lesson plans, demonstrating effective instructional materials in language arts, mathematics, science, social studies, and history.
- Taught courses in a virtual teaching environment, utilizing online platforms and resources.
- Designed lesson plans, curricula, homework, special projects, and reading assignments to foster student learning and engagement.
- Conducted online assessments and monitored individual student performance to maintain alignment with curriculum expectations.
- Provide feedback and assign grades to students’ course work.
- Track and maintain students’ attendance for online classes and report student absenteeism to school attendance system, parents, school principal, and school counselor.
- Leveraged various technology tools, including database systems, to enhance classroom instruction and actively engage students.
- Developed innovative approaches that were held as the model standard for meeting district goals in technology integration across the curriculum, experiential learning, literacy and diversity areas.
- Taught general education students as well as individuals with learning challenges and special needs within a mainstreamed, inclusive classroom.
- Commended for ability to redirect students exhibiting behavior problems.
- Selected to lead district-wide in-service on classroom management.
- Served on school committees and taskforces focused on curriculum development, textbook review, fundraising and anti-bullying efforts.
- Became a 'first-to-call' resource in current substitute teaching role, typically working four days per week. Personally requested by many full-time teachers to take over their classrooms during absences.
- BridgePrep Academy is a school that provides a secure, nurturing and stimulating atmosphere in which to grow and mature emotionally, intellectually, physically, and socially. BridgePrep believes in a student-centered educational philosophy that emphasizes hands on learning and students actively participating in learning.
Clinical Research Coordinator
South Florida Nephrology Group, PA
Coral Springs, USA
12.2014 - 04.2015
- Prepared quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.
- Executed protocol procedures including subject interviews, vital sign assessments, and electrocardiogram administration.
- Coordinated and oversaw research activities to ensure operational efficiency and compliance with study protocols.
- Evaluated proposed study protocols sample collection processes, data management plans, and potential subject risks.
- Organized and maintained study documentation including protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports.
- Monitored documents for all clinical research studies to ensure accuracy.
- Maintained and tracked study activities to ensure compliance with protocols with all relevant local, federal, and state regulatory and institutional policies.
- Conducted standard operating procedures (SOP’s), Good Clinical Practice (GCP) and/or International Conference on Harmonization (ICH) guidelines.
- Negotiated budgets and monitor investigator payments.
- South Florida Nephrology Group is the largest nephrology practice in Broward County with almost 20 years of excellent medical services and completely supports the research and development of existing and new drugs through the participation in clinical trials.
Drug Safety Specialist
Cordis a Johnson & Johnson Company
Miami Lakes, USA
10.2014 - 12.2014
- Completed the complaint assessment and identification of complaints related to adverse events and product malfunctions.
- Analyzed incoming product complaints, determined investigation requirements, and evaluated complaints to develop solutions addressing customer issues.
- Prepared sections of regulatory submissions and international vigilance reports for adverse events.
- Evaluated information from a technical perspective to insure appropriate analysis, investigation, determined the root cause, and documented prior to complaint closure.
- Tracked and documented the effectiveness of corrective actions taken to prevent recurring complaints.
- Collaborated with functional departments to implement corrective actions addressing recurring problems, enhancing overall product safety.
- Prepared information for the reimbursement process, assisted in initial assessments of product complaints to determine reportable complaint investigations between the quality assurance department, engineering, customer support and other departments.
- Cordis Corporation, a member of Johnson & Johnson's Family of Companies, is a recognized leader in providing physicians with breakthrough treatment solutions for peripheral vascular disease, a leader in circulatory disease management, interventional cardiology, and radiology and electrophysiology products for circulatory disease management.
Clinical Consultant /Document Specialist
Biotest Pharmaceutical Corporation (BPC)
Boca Raton, USA
03.2013 - 10.2014
- Manages archival of all BPC’s Clinical and Regulatory Affairs documents including clinical trial documents and regulatory authority submissions and correspondence.
- Managed development, maintenance and review of BPC’s paper and electronic record management systems including Trial Master Files (TMF) and the Regulatory and Immunotherapy systems.
- Implemented processes and tools to gather and organize documents, producing periodic guides and reports for effective record management.
- Maintained and updated electronic information systems that recorded, tracked, and managed regulatory submission documents.
- Process, file and archive all clinical and regulatory documents ensuring timely collection, maintenance, tracking and review of these documents.
- Led transition from paper to electronic regulatory records archive, developing a comprehensive plan to guide staff in record management and identifying preservation requirements.
- Identify the most appropriate records management resources and lead the development and implantation of proposals.
- Executed the freezing process for all electronic case report forms and related data, ensuring data integrity and compliance.
- Perform routine interim and final audits to ensure compliance with applicable work instructions, Standard Operating Procedures, Food and Drug Administration regulations, and ICH Good Clinical Practices guidelines.
- Conduct Standard operating procedures (SOP’s), Good Clinical Practice (GCP) and/or International Conference on Harmonization (ICH) guidelines.
- Provide documentation during audits by regulatory agencies and clients.
- Biotest Pharmaceuticals Corporation is a world leader in human plasma collection for therapeutic product production, operates 10 state of the art plasmapheresis centers located throughout the United States that are licensed by the FDA and Europe and conduct research and manufacture biotherapeutic products specializing in immunology and liver transplant therapy.
Regulatory Specialist
Miller School of Medicine at University of Miami
Miami, USA
03.2010 - 05.2012
- Prepared research protocols to monitor regulatory officials and agencies in anticipation of onsite audits by sponsoring companies and/or governing regulatory bodies; coordinated meeting and work product documentation with pharmaceutical monitors on a day-to-day basis; completed regulatory research protocol submissions, created consent forms, FDA Audits, and other compliant documentation related to ongoing clinical research studies, including document submission to the Institutional Review Boards (IRB), communicating with ancillary committees and industry.
- Ensured timely collection of protocol/project-related documentation, monitored data collection, verified source documents, and maintained protocol compliance; reported and documented SAEs, managed drug accountability records, updated laboratory certifications and investigator's study brochures; submitted protocol deviations, AEs, SAEs, and SAE reports to IRB; assisted in preparation of clinical study reports by tracking document submission timelines; reviewed regulatory documents and essential documents to ensure processes for site initiation, maintenance, and closeout were followed, maintaining Trial Master Files.
- Liaised between Principal Investigator and sponsors to maintain research documentation in compliance with regulatory bodies.
- Managed SharePoint and operational portal to organize and update study-specific information for team access.
- Conducted site initiation visits, close-out visits, interim monitoring visits, and FDA audits to verify compliance.
- Conduct Standard operating procedures (SOP’s), Good Clinical Practice (GCP) and/or International Conference on Harmonization (ICH) guidelines.
- Review protocols, protocols, ICF, safety reports, and deviations.
- Coordinate audits and site visits with the pharmaceutical monitors concerning compliance of regulatory documents.
- A private research university, with more than 15,000 students from around the world.
Education
Master of Science - Management & Administration of Educational Programs
Nova Southeastern University
Fort Lauderdale, Florida02-2007
Bachelors of Art - Business Administration
Trinity International University
Davie, Florida05-2004
Skills
- Regulatory Affairs
- Regulatory Compliance
- Regulatory Writing
- Clinical Trials Management
- Clinical Monitoring
- Clinical Research
- Clinical Development
- Quality Assurance
- Auditing
- Trial Master File
- Developed SIV
- CRO
- Pharmaceutical industry
Training
- Society for Clinical Research Sites - Investigator Oversight Informational Program, 2023
- Society for Clinical Research Sites – Adverse Events & Safety, 2023
- Society for Clinical Research Sites – Clinical Research Overview, 2023
- Society for Clinical Research Sites – IRB /IEC Responsibilities & Informed Consent, 2023
- Society for Clinical Research Sites – Conducting a Study, 2023
- Society for Clinical Research Sites – Essential Documents, 2023
- Society for Clinical Research Sites - Clinical Practice vs Clinical Research, 2023
- Society for Clinical Research Sites - Delegation & Training, 2023
- Society for Clinical Research Sites – Source Documentation, 2023
- Society for Clinical Research Sites – Investigational Product, 2023
- Society for Clinical Research Sites – Facilities & Equipment, 2023
- Society for Clinical Research Sites - Monitoring & Auditing, 2023
Timeline
Regulatory Coordinator
Segal Trials Services
02.2024 - Current
Regulatory Affairs Analyst
University of Miami School of Medicine
01.2024 - 06.2025
Team Administrator / Project Coordinator
Covance Laboratory Services
04.2021 - 10.2021
Elementary School Teacher 1st grade
BridgePrep Academy Elementary School
11.2017 - 06.2020
Clinical Research Coordinator
South Florida Nephrology Group, PA
12.2014 - 04.2015
Drug Safety Specialist
Cordis a Johnson & Johnson Company
10.2014 - 12.2014
Clinical Consultant /Document Specialist
Biotest Pharmaceutical Corporation (BPC)
03.2013 - 10.2014
Regulatory Specialist
Miller School of Medicine at University of Miami
03.2010 - 05.2012
Master of Science - Management & Administration of Educational Programs
Nova Southeastern University
Bachelors of Art - Business Administration
Trinity International University