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Click here or scroll down to respond to this candidate SUMMARYHighly skilful and dedicated Clinical/Research Support Professional with extensive experience in the coordination, planning, and support of daily clinical operational and clinical functions in various research settings. Demonstrated capacity to provide comprehensive clinical and regulatory support and effectively manage all essential tasks. Adept at developing and maintaining detailed administrative and procedural processes that reduce redundancy, improve accuracy and efficiency, and achieve organizational objectives. Highly focused and results-oriented, supporting clinical staff and operations to provide highest level of patient care, good clinical practice, and deadline-driven operations; able to identify goals, set priorities and resolve complex issues in initial stages. Proficient in MS Office Systems, Microsoft Windows operating system, type 60 wpm with complete accuracy.EXPERIENCE
Date: From December 2023 to July 2024-ContractCompany Name: Virtual Research GroupJob title: Study Coordinator Coordinate and work independently on all study requirements to ensure the study is run smoothly in accordance with the protocol and GCP guidelines. Work with multiple technologies to coordinate the overall participant experience. Oversee home healthcare personnel and all aspects of study visits including coordination of all parties and procedures (e.g., telehealth visits, study visits, etc.). Work with and coordinate between Principal Investigator, Sub-Investigators, Home Healthcare Nurses, and all vendors (e.g., technology, equipment, IP supply, etc.). Follow up with the participant and/or home healthcare nurse regarding any missing data and/or data queries. Routinely contact the participants through pregnancy until delivery and after randomization performing study telephone visits. Schedule all study visits. Assist potential participants with medical record request forms for their hospital delivery in order to obtain potential subjects discharge summary. Coordinate record sharing from the participant s pediatrician routinely throughout the study to ensure all concomitant medications, AEs, and SAEs are reported. Data entry for all concomitant medications, procedures, AEs, and SAEs.Date: From September 2022 to July 2023Company Name: Syneos Health/USA-N-Carolina-Home-BasedJob title: SSU & Regulatory Specialist II Responsible for the quality and deliverables at the country level; follows project requirements and applicable country rules, with moderate oversight from the SSU Country Manager. Works within the forecasted submission / approval timelines and ensures they are complied with and tracks milestone progress in agreed upon SSU tracking system in real time; if forecasted timelines are not reached: investigates and provides clear rationale for delays, provides support on contingency plan to mitigate impact, and escalates the issue as soon as identified. Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion. Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WI) in a timely manner, keeps training records updated accordingly and ensures timesheet compliance. Supports continuous improvement of quality in all Site Start-Up (SSU) components at the country level where assigned (submissions, essential document collection, communication to Competent Authorities and ECs, etc). Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements. Responsible for one or more of the following functions at the country level. Local Submissions Specialist-Follows the project direction provided by the designated country Start Up advisor (CSA) and SSUL. May serve as a point of contact for the PM/SSUL (or designee) during start-up on allocated projects. Complies and/or reviews essential document packages for site activation and may also be involved in essential document collection from site. Prepares and submits Central EC Applications , Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required. Prepares ongoing submissions, amendments, and periodic notifications required by central and local EC and RA and other local regulatory authorities as needed within the country; includes safety notifications as required by local rules, with moderate oversight from the SSU Country Manager. Country Start-Up Advisor - Acts as Subject Matter Advisor for in-country performance within the Site Start-Up. Supports country-level intelligence on start-up (SU) and clinical trial regulatory (CTR). Ensures that local country regulatory intelligence, as it pertains to the activities of the local SU and CTR team, is maintained on the central repository, e.g., Competent Authority submissions, EC submissions, notifications to data protection authorities, notifications/applications to any other local/federal/national body, and import/export license applications where these are obtained with RA applications. In absence of legal advisor or dedicated subject matter may provide support for data protection at the country and provide guidance at a country level on data protection statements that need to be included on those documents which the Sponsor has contracted to the Company start-up group to adapt to local requirements. This may include the Principal Investigator/Informed Consent and the Confidential Disclosure Agreement/contract template. Provides input in local SOPs and WI. Supports the creation of internal training materials on local legislation requirements. Provides input to the team to assist with EC or CA issue resolution at the country level. Local Site ID and Feasibility Support - Provides support with site selection lead and PM/SSUL to ensure that the appropriate sites are selected for individual studies based on the requirements of the clinical trial. Local Investigator Contract and Budget Negotiator - Provides support to SSUL to agree on country template contract and budget. Produces site-specific contracts from country template. Provide support in submissions for proposed contract and budget for site. Provides support in negotiating budget and contract with site via Site Contracts Service Centre and SSUL with Sponsor until resolution of issues and contract execution. Performs quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata.
Date: From December 2021 to July 2022Company Name: FHI Clinical INC./ USA-N-Carolina-Home-Based
Job title: SSU Associate II Responsible for quality deliverables at the at the country level for site start-up in one or morecomponents. Proactively forecasted submissions/approval timelines, providing clear rationales for delays, contingency plans to mitigate impact, and escalating issues as soon as identified. Primary Regulatory/Start Up point of contact for the Project Manager, and Clinical Manager during start-up on allocated projects assigned. Prepared and submitted Central EC/IRB Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required. Prepared ongoing submissions, amendments, and periodic notifications required by central andlocal EC and RA, and other local regulatory authorities as needed within the country; includes safety notifications as required by local rules. Performed essential document collection and review, ensuring that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH/GCP guidelines. Ensured accuracy and completeness of trial master file documents submitted during start-upand performs a QC review of files before transfer to Maintenance for filing in TMF. Provided quality review and revision of informed consents (ICF) and adapt templates as appropriate. Worked within the scope of Clinical Management Plan (CMP), study processes, ICH-GCP and/or ISO14155 and any other requirements mandated by the study. Reviewed and trained on Regulatory and Clinical Operations SOPs, WGs and ADs related to Study Start-Up and regulatory tasks. Mentored and trained junior level staff.Date: From November 2020 to December 2021Company Name: UNC School of Medicine/USA-N-Carolina-Home-Based
Job title: SSU/Regulatory Associate Communicated with the Institutional Review Board (IRB) and research sponsors. Complied with federal, state, and local laws, regulations, and guidance s applicable to the conduct of oncology clinical research. Responsible for quality deliverables at country level for site start-up in one or more components. Participated in the collection, compilation, and management of data/information; quality assurance and quality control; analysis by statistical or other means; generation/production ofnew data/information; and editing and formatting of reports.
Prepared and submitted Central EC/IRB Applications, Local EC Applications, RA Applications,and other local regulatory authorities or hospital approval submissions as required. Performed essential document collection and review, ensuring that sponsor and investigator obligations are being met and are following applicable local regulatory requirements and ICH/GCP guidelines. Ensured accuracy and completeness of trial master file documents submitted during start-up and performs a QC review of files before transfer to Maintenance for filing in TMF. Served as the primary Regulatory/Start Up point of contact for the Project Manager, and Clinical Manager, during start-up on allocated projects. Trained and supervised new staff, students, and others.
Date: From November 2018 to July 2021Company Name: Duke University Hospital/USA-Durham, North Carolina
Job title: Certified Nursing Assistant/Health Unit Coordinator Provided direct nursing support under the direct supervision of a registered nurse to ensure a high level of patient care assisting patients. Performed trach care, q2 hr turns to prevent skin breakdown, foley care, oral care, blood glucose checks, transferring improved patients to stepdown care, etc. Maintained patient charts, files and all PHI while following good clinical practice guidelines, SOPs, and HIPAA guidelines. Provided fast paced, clerical and administrative support to various levels of nursing staff in the Neuro Intensive Care Unit.Date: From June 2013 to July 2017Company Name: UNC Health Care/USA-Chapel Hill, North Carolina
Job title: Study Coordinator Responsible for the coordination and management of numerous regulatory and reporting requirements for multiple clinical studies. Assisted in the development and review of specific informed consents. Reviewed and performed ICF consents. Analyzed data/information for accuracy, validity and integrity to maintain quality control and assurance.
Exhibit working knowledge of research principles and methods of data entry, collection, and analysis to complete defined assignments independently. Experienced the use of qualitative data analysis, including use of analytic software, ie Atlas ti. Organized, collect, record and present data/information within defined research parameters. Ensured quality control. Summarized data/information collected. Carried out collection and screening under close supervision when atypical methods are used. Compiled and organized data/information from different sources to develop reports using established formats. Lead and updated exchange of research information through dialogue, instruction, and demonstration. Contributed to preparation of publications, reports, and other presentations. Applied criteria for extract of data; Prepared reports and presentations for Sponsors and Project Leads; Developed guidelines for implementation of procedures. Ensured an efficient start-up process on assigned studies. At a project and local level, act as Site Start-up Lead (SSUL). Communicated daily with various site staff (PI, Study Coordinators, Nurse Clinicians, Sub-Is and etc.), and across multiple departments. Interfaced with relevant functional leads to ensure appropriate prioritization of essential.THERAPEUTIC EXPERIENCE
Therapeutic Area & PhaseInfectious Disease - Immunization, VaccinesOncology - Cancer, Leukemia - Cancer, Multiple Myeloma - DiabetesEDUCATIONHS Diploma, Hillside High School, Durham, NC 2002BA Healthcare Administration, University of Arizona Global Campus, Chandler, AZ 2024LANGUAGES SPOKEN English-Fluent |
