Natalie Careri's Email Addresses & Phone Numbers

📖 Summary

Senior Clinial Project Manager @ IQVIA Biotech Independently manages multi-center clinical trials ranging from moderate to high complexity. Responsible for facilitating and managing the cross-functional team, interacting with sponsors/vendors and managing clinical trial timelines, project budgets, deliverables, etc. Rochelle Park, NJProduct Specialist/Sales Associate @ CD&P HEALTH PRODUCTS Client relations, sales representation, inventory management, design consultation, product manufacturing and packaging From May 2006 to September 2007 (1 year 5 months) Clinical Project Manager @ Novella Clinical, formerly TKL Research Clinical Trials Division Independently manages multi-center clinical trials ranging from moderate to high complexity. Responsible for facilitating and managing the cross-functional team, interacting with sponsors/vendors and managing clinical trial timelines, project budgets, deliverables, etc. Clinical Trial Manager II @ TKL Research Assists Clinical Project Manager with management of complex studiesCommunicates with the project teamCreates Project PlansReviews protocol and CRF guidelinesAssists Clinical Project Manager with planning of Sponsor Kick off meeting, Investigator meeting, UAT testing, creating study newsletters, study enrollment/contingency planning and study budget managementAttends and presents at investigators’ meetingReviews source document template, protocol and ICF documentsAssists with project team member trainingProvides feedback on feasibility questionnaires/Manages and provides oversight to site feasibility/site selection process (interviews investigator and/or CRC, assesses investigator’s ability to meet enrollment requirements, etc.) Responsible for preparing/reviewing/maintaining project specific metrics (i.e. number of activated sites, enrollment metrics)Acts as Project Manager backup to team meetingsMiscellaneous duties, as necessary, in support of Clinical Monitoring and Project Management initiatives, and business priorities and objectives. Clinical Trial Manager @ TKL Research Assists Clinical Project Manager with management of complex studiesCommunicates with the project teamCreates Project PlansReviews protocol and CRF guidelinesAssists Clinical Project Manager with planning of Sponsor Kick off meeting, Investigator meeting, UAT testing, creating study newsletters, study enrollment/contingency planning and study budget managementAttends and presents at investigators’ meetingReviews source document template, protocol and ICF documentsAssists with project team member trainingProvides feedback on feasibility questionnaires/Manages and provides oversight to site feasibility/site selection process (interviews investigator and/or CRC, assesses investigator’s ability to meet enrollment requirements, etc.) Responsible for preparing/reviewing/maintaining project specific metrics (i.e. number of activated sites, enrollment metrics)Acts as Project Manager backup to team meetingsMiscellaneous duties, as necessary, in support of Clinical Monitoring and Project Management initiatives, and business priorities and objectives. From December 2013 to December 2015 (2 years 1 month) Clinical Trial Associate II @ TKL RESEARCH, INC Communicates with project team (Sponsor, CRAs, sites, vendors, etc.) Prepares, reviews and approves site regulatory documents Prepares IRB submissions Develops standard study logs and tracking forms Prepares study regulatory binders for distribution to sites Orders clinical supplies for distribution to sites Prepares study newsletters Reviews monitoring reports Creates source documents Conducts Investigator Feasibility Negotiates study budgets Performs Serious Adverse Event Reconciliation Assists in the creation of project plans Trains entry level personnelClinical Trial Associate I Sept. 2007-Nov. 2009 Prepares, reviews and approves site regulatory documents · Prepares IRB submissions · Communicates with the IRB regarding submissions · Tracks IRB approvals · Maintains Master file and Financial binder · Tracks enrollment activities · Takes meeting minutes · Prepares Weekly Status Reports · Assists in the preparation of newsletters From November 2009 to December 2013 (4 years 2 months) Clinical Trials Associate @ TKL Research (CRO) Assists Clinical Project Manager with management of all activities related to multi-center trials.Communicates with project team (Sponsor, CRAs, sites, vendors, etc.)Conducts site feasibility (interviews investigator and/or CRC, assesses investigator’s ability to meet enrollment requirements, etc.).Performs investigator selection.Functions as primary communicator with investigative sites on budgets, regulatory documents and informed consent elements, as required by assigned Clinical Project Manager.Creates study plans.Provides backup to team meetings (prepares agenda and reviews minutes) and maintains study timelines.Conducts sponsor teleconferences.Reviews monitoring reports.Creates source documents.Performs Serious Adverse Event Reconciliation.Attends and presents at Investigator’s Meetings and provides support, as needed.Performs observation monitoring visits.Mentors junior staff and facilitates resolution of escalated issues regarding budgets, regulatory documents and informed consent elements, and site related issues as required by assigned Clinical Project Manager.Trains entry level personnel.Miscellaneous duties, as necessary, in support of Clinical Project Management initiatives and business priorities/objectives. From September 2007 to November 2009 (2 years 3 months) Product Specialist / Sales Associate @ CD&P HEALTH PRODUCTS Client Relations Sales Representation Inventory Management Design ConsultationNatalie A. Careri Curriculum Vitae Product Manufacturing and Packaging From September 2006 to September 2007 (1 year 1 month) Senior Veterinary Technician @ VERNON VETERINARY CLINIC Phlebotomy and Laboratory Testing Antibiotic Administration Surgical assistance/post-surgical monitoring Maintaining sterile working environment Inventory Management Extensive client/doctor/customer relations Responsible for training new staff From May 2006 to September 2006 (5 months) Molecular Cell Biology Student Intern @ MEDICAL DIAGNOSTIC LABORATORIES, LLC Cell culture of urinary bladder, vaginal, ectocervical, endocervical and lung epithelial cells. Conventional and Real Time Polymerase Chain Reaction DNA and RNA isolation and purification Gel electrophoresis Northern Blotting Bead based cytokine analysis using Luminex technology From September 2005 to May 2006 (9 months) Senior Veterinary Technician @ OAKLAND ANIMAL HOSPITAL Phlebotomy and Laboratory Testing Antibiotic Administration Surgical assistance/post-surgical monitoring Maintaining sterile working environment Inventory Management Extensive client/doctor/customer relations Responsible for training new staff From September 2002 to May 2006 (3 years 9 months) Veterinary Technician @ NUTLEY ANIMAL HOSPITAL Phlebotomy and Laboratory Testing Antibiotic Administration Surgical assistance/post-surgical monitoring Maintaining sterile working environment Inventory Management From September 2000 to August 2002 (2 years)