• Oversee execution of clinical studies in compliance with ICH GCP, study protocols, and SOPs
• Responsible for meeting timelines and communicating issues potentially causing late completion
• Communicate with sponsors to ensure execution meets client’s expectations
• Manage staff, study activities, resources, samples, and source documents
• Create, review, and revise all essential documents required for study initiation, ex. study protocols, source documents, and study reports
• Train staff on study activities or protocol specific activities
• Compile Trial Master File and Case Report Forms
• Perform clinical data review of data listings and summary tables, including query generation
• Record protocol or SOP deviations and obtain impact assessments from internal clinical pharmacology or biological statistician teams
• Perform technical task as needed during study execution, e.g. phlebotomy, plasma processing, monitoring adverse events, ECGs
- Clinical Study Manager at Algorithme Pharma USA
- Research Technician at Novum Pharmaceutical Research Services
- Research Assistant at Psychology Department - North Dakota State University
2 years, 8 months at this Job
- Bachelor's - Zoology
- Bachelor's - Psychology
• Manage clinical study submissions, study start-up and study conduct in clinic
• Conduct all pre-study, in-study, and post-study meetings and conferences for all study activity including Study Initiation Visit, Dose Escalation, and regular updates to sponsors
• Trained on in clinic duties such as vitals signs, assisting with dosing, assisting with blood draws, assisting with ECG and holter extractions, and reviewing urine and bloodwork lab values
- Clinical Study Manager at Celerion
- Clinical Project Coordinator/Clinical Research Associate (Monitor) at Cook Research
- Lafayette Journal & Courier at Gannett, Co. Inc
- Client Operations Manager at Purdue University
5 months at this Job
- Bachelor of Science - Technology, Leadership & Innovation
♦ Commended for commitment to ensuring the success of Sienna's programs and collaborative culture
♦ Management of 6 pivotal clinical trials and 1 long term follow up study
♦ Exceeded enrollment goals for all 6 pivotal clinical trials
• Managed the performance of contract research organizations (CROs), laboratories, service providers, and individual contractors/consultants (i.e., external service providers) in the context of study planning and execution
• Creatively met enrollment goals for all 6 pivotal studies by identifying and activating additional qualified sites, using sites experienced with the program, and adding a recruitment vendor specialized in social media
• Managed data cleaning activities ahead of database lock including reconciliation of clinical database, safety database, and central imaging vendor data
• Consistently led weekly CRA meetings and served as primary contact for all CRAs on the program
• Managed the audit of the eTMF for all studies ensuring the eTMF was complete, up-to-date, accurate, and inspection-ready
• Completed audit responses for 6 clinical sites
• Supported ISO audit in November 2018 with no significant findings for clinical operations
• Collaborated on the implementation of quality risk management (QRM) process in new trials
• Contributed to key operational sections of clinical study protocols
• Drove development of essential study documents (e.g., investigator's brochure, informed consent form, Clinical Monitoring Plan, Data Management Plan, Statistical Analysis Plan, Risk Management Plan), guidelines, tools, instructions, forms, newsletters, and data collection instruments (e.g. [e]COA, [e]CRF)
• Maintained accountability of program-wide investigational product and reconciliation processes and ensured that all product accountability issues were resolved prior to study closure
• Verified accuracy of external service provider invoices by validating the work performed was within scope and charges were in line with contractual agreements
• Ensured safety events and product complaints were reported, assessed and promptly closed in accordance with regulatory requirements and Sienna policies and procedures
• Contributed to the development and review of standard operating procedures governing clinical study activities
• Worked closely with Project Management to generate and manage clinical study timelines
• Led the clinical study team in the operational planning and execution of assigned studies per program plans, timelines, budgets, and standards of compliance and quality
• Ensured investigative sites were adequately monitored and managed to achieve compliance, data quality and timeline deliverables
- Clinical Study Manager at Sienna Biopharmaceuticals, Inc
- Clinical Trial Manager at Atara Biotherapeutics, Inc
- Clinical Research Manager at Kythera Biopharmaceuticals, Inc
- Clinical Research Associate at
1 year, 7 months at this Job
- Certificate in Clinical Trials Administration
- B.S. - Biological Sciences and B.A. History
• Project lead for multi-national medical device clinical trials
• Drive protocol and associated study documentation completion of assigned clinical studies
• Interact with potential/selected study sites and vendors
• Manage study timeline adherence and deliverables
• Manage contract requirements for sites and vendors
• Lead assigned clinical study teams
• Primary contact for all protocol clarifications and logistical project-related issues
• Submit study documentation and draft responses for EC/IRB approval
• Conduct weekly study execution meetings with global team to communicate study updates/progress
• Manage/develop study budgets and clinical trial agreements
• Manage CEC/DMC meetings; adverse event adjudications
- Clinical Study Manager at Nuvaira Incorporated
- Clinical Operations Specialist (CRA) at Hollister Incorporated
- Clinical Project Associate at Medline Industries Incorporated
- Quality Assurance/Regulatory Affairs Executive Administrative Assistant at Medline Industries Incorporated
6 months at this Job
- Bachelor of Science - Business Management
- - Certified Pharmacy Technician
• Coordinate the planning, development and implementation of clinical protocols, procedures and operating systems in accordance with parameters set by study sponsors and the principal investigator.
• Perform administrative and regulatory binders according to the study specific.
• Oversee and assist complex studies by maintaining study files, QC reviews, clinical data entry and analysis.
• Recruit, enroll and screen research participants through monitoring and scheduling research activities of subject participants.
• Monitor and timely report Adverse Events (AE) and SAE, recognized protocol deviations and violation with a pragmatic resolution according to protocol stipulation.
• Assist in the generation and review of Standard Operating Procedures.
• Management of the protocol document and refine through proofing, editing, amending and study logistics coordination.
• Content design and verification according to FDA and RIB/ethics compliance.
• Maintain line of communication with the RIB and FDA regarding study status update.
- Clinical Study Manager at Celerion Inc
- Director Of Healthcare Service at Global Vision Source Inc
- Project Manager at MD24 House Call Inc
- Clinical Research Associate at ConjuChem Inc
1 year, 3 months at this Job
- Doctor of Education - Health Care Administration
- Diploma - Clinical Research Study
- Master Of Science - Organization Management
- Bachelor of Science - Microbiology
• Monitor and Manage internal study sites and documentation, while completing reports in a timely manner.
• Oversee all study-related procedures to ensure they are carried out in accordance with protocol and regulatory guidelines.
• Provide status updates regarding projects to clients and other departments while, managing study timelines and proactively identifying delays and possible solutions to meet timelines.
• Manage and Maintain external vendors/CROs to ensure that deliverables are completed on-time, and within budget.
• Develop metrics and tracking mechanisms to ensure quality and timeliness of study deliverables.
• Ensure that study documentation is audit-ready always and evaluate and develop clinical study reports and abstracts.
• Work on special recruitment projects to develop ways to increase enrollment and overall revenue.
- Clinical Study Manager at Elligo Health Research, Inc
- Clinical Research Study/Site Lead at Elligo Health Research, Inc
- Clinical Research Coordinator at Early Phase
- Processing Lab Shift Manager at Early Phase
1 year, 2 months at this Job
- Bachelor of Biology Concentrating in Medical Science - Biology Concentrating
Certified EKG Technican
- Clinical Study Manager at Elligo Health Research
- Clinical Trials Study Coordinator at Emeritas Research Group, LLC
- Cardiovascular Technologist at Adventist HealthCare
- Assistant Manager/ Marketing Manager at Geppetto Restaurant of Maryland
4 months at this Job
- - Pre-Medical Studies
- B.S - Public Health
- A. A degree - General Studies
• Provide project management expertise to Study Accountable Person (SAP) and study team members globally.
• Serve as point of contact for the study teams for TMF matters and liaise with TMF Subject Matter Experts (SMEs) and process owners to help their understanding of requirements and associated solutions to ensure trial master files are inspection ready at all times.
• Assist in the development and delivery of training materials at the study level and provide subject matter expertise.
• Accountable to ensure that the documents are filed to meet the required timelines and ensure there is no deviation from the plan and follow up appropriately.
• Accountable to ensure all relevant studies follow GSK SOPs and GCP.
• Address requests in a timely and efficient manner
- Clinical Study Manager (CW) at GSK
- Lab Manager/Research Associate at The Children's Hospital of Philadelphia
- Lab Researcher at National Jewish Medical and Research Center
- Staff Research Associate at University of California at San Francisco
2 years, 4 months at this Job
- M.S. in Applied Statistics - Applied Statistics
- B.S. in Biology - Biology
Manager of the NRG Oncology clinic portfolio, consisting of hundreds of different studies Tracking and categorizing records for expedited approval or disapproval of protocols between doctors Submission of weekly reports to FDA for new or amended protocols as approved by NCI Use of SharePoint to facilitate review of all protocol submissions from NRG between doctors and investigators Manage and host conference/group calls through WebEx Coordinate meetings amongst investigators and doctors
- Clinical Study Manager at Cabezon Group, National Cancer Institute
- Research Assistant at Chesapeake Bay, MD
- Laboratory Research Assistant at Department of Biology of Salisbury University
2 years at this Job
- Bachelor of Science - Biological Sciences
- - Liberal Arts
Protocol development of global clinical studies, training of site investigator and staff, Contract Research Organizations, central laboratories and vendors. Planning, managing and reporting all aspects of global clinical studies by working with study management team to oversee cross- functional study activities. Creating and reporting clinical study updates to management on a regular basis; report on performance to plan. Assist with monitoring, and/or assist CRAs with monitoring activities, to ensure compliance with study protocols, regulatory requirements, and Smith & Nephew procedures. Assist in compiling information for scientific publications in international peer-reviewed journals and other publications, conferences, and other media as appropriate.
- Clinical Study Manager at Medical Device
- Clinical Research Associate, National at DySiS Medical (Device)
- Clinical Research Document Specialist I (Contract) at Alcon Research Ltd
- Certified Clinical Research Coordinator at KRK Medical Research
1 year, 5 months at this Job
- Bachelor of Science degree - Biology