Regulatory Coordinator Resume
Headline : Seeking a full-time position that will permit to utilize Data Entry/Administrations skills, which will also allow to acquire and fulfill personal growth and development.
Skills : Regulatory Compliance.
- Promoted from Research Coordinator Assistant to Regulatory Coordinator) Performed Regulatory on more than 60 research studies on a daily basis.
- Gathered information from Study Coordinators, Physicians and other staff and study sponsors as needed for the submission of regulatory documents.
- Created/maintained master regulatory files from pre- study site visit through close-out.
- Coordinated efforts associated with the preparation of regulatory documents to the sponsors.
- Submited IND Safety Reports to IRB on behalf of the Principal Investigator regularly, and as needed.
- Met with the Clinical Research director to discuss new studies and upcoming of current studies.
- Met with study monitors coordinate and schedule Monitor Visits, PSSV's, SIV's, and Audits on a monthly basis, update IRB summaries for current studies.
Medical Coding Specialist
Jr. Regulatory Coordinator Resume
Objective : Objective is to have the opportunity to apply vast, professional, accumulated knowledge to the position of Administrative Specialist with Payroll. To gain knowledge that have yet to be exposed to. To learn from supervisors and peers how to achieve success in the payroll system. A summary of professional background.
Skills : MS Office Proficient, Advanced Computer Working With Various Programs.
- Charged of all regulatory affairs operations of different clinical trials, vaccine studies, research studies and pharmaceutical protocols in order to be in compliance with local and Federal Regulations.
- Charged of completing submissions and annual reviews applications of clinical trials protocols under Institutional Biosafety Committee (IBC) revision.
- Coordinated and supervised the implementation and performance of clinical trials, pharmaceutical protocols and research studies according to local and Federal Regulations.
- Assigned to train, mentor and supervise personnel on new studies to be implemented on the clinical research site.
- Updated and keep organized clinical research protocol regulatory documentation.
- Reviewed and audited clinical research records, correct any data discrepancy based on quality control and quality assurance policies.
- Charged of submission of regulatory documents to the DAIDS Protocol Registration System, as well follow up.
Sr. Regulatory Coordinator Resume
Summary : a Masters of Science in Clinical Research with 2 years of clinical research experience at Dana-Farber Cancer Institute in the Center for Immune-Oncology. looking to secure a challenging position that will utilize clinical and research experience, education and unique innovative abilities to contribute to the success of many clinical trials.
Skills : Project Management.
- Compiled and submitted regulatory documents for developmental products.
- Tracked and ensured that global regulatory strategies and projects were completed within the required time frames.
- Provided regulatory advice, supported and serviced to team members in the development of effective regulatory strategies.
- Dispensed applicable and timely communication on project-specific regulatory issues among Regulatory Project Director, project teams and cross-functional team members.
- Represented Regulatory Project Director at team meetings (Safety Team, Clinical Project Team, Global Project Team, Research Strategy Team).
- Supported Regulatory Project Director with activities associated with trial continuation (i.e.
- Ensured all submissions on a global basis, were of the highest quality to ensure rapid acceptance by global regulatory authorities.
Regulatory Coordinator I Resume
Headline : Over 25 years experience in the Oil & Gas Industry with in-depth knowledge and understanding of GOM/West Virginia/Ohio regulatory issues and additional experience in environmental and safety. Responsibilities include identification and interpretation of regulatory requirements, liaising with regulatory agency personnel, preparation, submittal and management of necessary plans, permits and applications for drilling, production, and development.
Skills : Clinical Research, Clinical Trials, Good Clinical Practice, Microsoft Office.
- Created and updated label manuscripts using Quark Express.
- Reviewed and audited bulk formulas to verify label claims and ingredient composition.
- Reviewed Finished Product Information Forms to ensure label accuracy.
- Ensured correct Standard of Identity labeling for active ingredients and excipients.
- Assisted in ensuring high priority new product launches meet their deadline for Pure Protein Bars, Met-RX protein shakes, and Balance Bars.
- Ensured FDA compliance across all brands.
- Participated as an integral part of cross-functional decision-making team.
Various Philanthropic Activities
Regulatory Coordinator II Resume
Headline : Highly qualified Regulatory Coordinator with experience in the industry. Enjoy creative problem solving and getting exposure on multiple projects, and would excel in the collaborative environment on which your company prides itself.
Skills : Human Resources, Accounts Payable, Budget Management, Procurement.
- Supported the day-to-day operations of a multi-jurisdictional regulatory administration office.
- Assisted in development and processing of regulatory filings/reports, special utility service contracts; and finalize for filing and approval with state regulatory commissions.
- Ensured filings and reports are within compliance guidelines.
- Composed and produced correspondence, reports, spreadsheets, contracts, and proposals.
- Completed expense reports for management and case specialist.
- Coordinatored and tracked departmental budgets and work with appropriate department on journal entries.
- Assisted with the on-boarding of new employees.
Bachelor Of Arts In Political Science
Regulatory Coordinator III Resume
Objective : Experienced clinical research professional with wide-ranging knowledge of Phase I-IV oncology clinical trials. Skilled in NCI-funded, industry-sponsored, and investigator-initiated study development and implementation. Excellent communication and writing skills, with a collaborative interaction style that achieves goals and builds a team atmosphere. Strong knowledge of study coordination procedures and regulatory affairs.
Skills : Oncology Clinical Trial Research, Protocol Development, Regulatory Submissions, Good Clinical Practice.
- Designated Cancer Center meeting the highest standards for cancer care and research.
- Completed regulatory documentation and IRB submissions, worked with Office of Sponsored Projects to meet financial needs of institute and sponsor, and coordinated study start-up with clinical research staff.
- Monitored and maintained regulatory approvals for over 120 studies.
- Assisted principal investigators with development and editing of investigator-initiated and NCI-funded research protocols.
- Developed and wrote standard operating procedures for Clinical Trials Office.
- Edited portions of NCI grant applications and annual reports.
- Mentored clinical trials staff on clinical research and regulatory procedures.
Bachelor Of Arts Summa Cum Laude In Behavioral Science & Health, Anthropology Minor
Regulatory Coordinator/Assistant Resume
Headline : To further career within the field of clinical research with a dynamic company with potential for growth.
Skills : Microsoft Office, Oncore, IRB Reporting.
- Managed up to 75 trials, pharmaceutical and government, and complete and maintain all study regulatory documents per FDA guidelines.
- Created and amended all trial ICFs per site standards and FDA/ICH guidelines.
- Developed and updated site standard operating procedures and work processes.
- Worked closely with site compliance to verify that site regulatory procedures fall under FDA/ICH regulations.
- Managed all National Cancer Institute registration for site staff and investigators.
- Managed all credentials for site staff and investigators, including HSP/GCP training, CVs, MLs, etc.
- Communicated on a daily basis with up to 35 clinic staff members on regulatory processes and operations.
Bachelor Of Science In Psychology
Associate Regulatory Coordinator Resume
Summary : To obtain a challenging position with advancing career opportunities that will allow to use knowledge, critical thinking, communication, and organizational skills to the fullest. display an eager initiative and am able to multi-task well.
Skills : Legal Research, Regulatory Compliance, Access, Excel.
- Prepared survey filings to California Air Resources Board, Environment Canada, and FDA.
- Reviewed international laws pertaining to artwork declaration requirements.
- Substantiated marketing claims for QVC EU's on-air advertisements.
- Created and maintained product information files for global compliance needs.
- Used analytical and multi-tasking skills to track and to update detailed risk/status reports.
- Worked cross-functionally with product development to formulate new products, create ingredient listings, and to implement a system of formula control for international registration purposes.
- Resolved consumer conflicts pertaining to product safety and quality control.
JD In Intellectual Property
Assistant Regulatory Coordinator I Resume
Summary : Over 15 years of management experience in the wellness industry working directly with company owners, manufacturing facilities, regulatory compliance, quality assurance, and coordinating with staff on product knowledge, sales, customer service, merchandising, profit/loss, forecasting, and inventory.
Skills : Technical Proficiencies: Windows MS Office Oracle Customer Relationship ManagementClinical Trial Managment Systems.
- Managed regulatory activities of clinical trials in the Pediatric Oncology disease teams.
- Prepared trial applications, renewals, protocol amendments, Informed Consents, and other documents for Institutional Review Board approval, working through clinical trial management system.
- Reviewed and submited IND safety reports working as a liaison between investigators and sponsors.
- Maintained all regulatory files to conduct studies in accordance with relevant, current GCP/ICH guidelines and SOPs.
- Supervised and overseed day to day activities of all 40 clinical trials in disease team portfolios.
- Lead weekly team meetings, organize agenda, providing all regulatory updates.
- Trained and coordinated work of temporary and contract staff.
Master In Public Health
Regulatory Coordinator Resume
Objective : Highly qualified Regulatory Coordinator with experience in the industry. Enjoy creative problem solving and getting exposure on multiple projects, and would excel in the collaborative environment on which your company prides itself.
Skills : Human Research, Education.
- Prepared protocols for IRB submissions.
- Oversawed retrospective chart review projects for Lipid Clinic.
- Helped Research Coordinators process serum samples and prepare to ship to sponsor.
- Scheduled all clinical research subject appointments for Drug, Device, and Lipid Clinic.
- Prepared Regulatory Documents for initiation of clinical trials.
- Prepared PowerPoint presentations for Cardiologists (80) educational meetings.
- Screened and consented subjects for potential enrollment into clinical trials.
Bachelor's In Psychology