Cleo James

Cleo James Email and Phone Number

Associate Project Manager I, Start-up @ Fortrea
Cleo James's Location
United States, United States
Cleo James's Contact Details
About Cleo James

I am highly motivated and dedicated professional with a proven ability to demonstrate excellent project management, analytical and communications skills coupled with determination to exceed corporate and personal goals.Experience In House CRA, Clinical Trial Coordinator with Five plus(5+) years of experienced in preparation and budgeting Five plus(5+) years of experienced IRB submission and documentationHeld positions in fields including areas of Microbiology, Clinical Research, QA, Telecommunications, and FinanceExperienced with Intralink, eTrials EDC, Microsoft Office Suites, Early development Phase I thru Phase IV trials, Study start up, closeout visits, TMF, CTMS, IRB Submissions, AE/SAE Reporting, Study Matter Expert and Time management

Cleo James's Current Company Details
Fortrea

Fortrea

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Associate Project Manager I, Start-up
Cleo James Work Experience Details
  • Fortrea
    Associate Project Manager I, Start-Up
    Fortrea Jul 2023 - Present
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  • Fortrea
    Site Readiness And Regulatory Senior Specialist
    Fortrea May 2023 - Jul 2023
    United States
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  • Fortrea
    Senior Study Start-Up Specialist
    Fortrea Sep 2016 - Jul 2023
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  • Fortrea
    Regulatory Site Service Specialist Ii
    Fortrea Sep 2016 - May 2019
    United States
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  • Fortrea
    Study Start-Up Specialist Ii
    Fortrea Sep 2016 - May 2019
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  • Fortrea
    Regulatory & Site Services Specialist 2
    Fortrea Sep 2016 - Jan 2019
    • Support the feasibility and site selection process on designated studies with support from senior team members• Serve as the primary contact with competent authorities (CAs), ethics committees (ECs) and/or investigative sites throughout the study. • Work with investigative sites to collect the required investigator and regulatory documents for a study.• Collate documents required for site activation in accordance with the country specific checklist and in the required timelines.• Assist with preparation of Clinical Trial Applications (CTAs) packages including initial submission, amendments and End of Trial Declarations as well as submission of notifications and status reports to the CA and IRB/IECs and to any other applicable country-specific authority/body, in assigned countries (except FDA).• Liaise with RSS Project Lead/Manager regarding preparation of responses to questions from CAs and IRB/IECs, for assigned countries. Assist with submission of responses to CA and IRB/IECs and to any other country-specific authority/body after Regulatory Project Lead/Manager approval.• Assist in the development of Informed Consent Forms, labels and other patient facing material in accordance with country-specific requirements.• Coordinate and/or perform the preparation, quality control review, and submission of CTA packages including initial submission, amendments and End of Trial Declarations as well as non-substantial notifications, status reports etc. to the CA and IRB/IECs and to any other country specific authority/body in assigned countries (except FDA).• Prepare and respond to Competent Authority (CA) and Ethics Committee (EC)/Institutional review Boards (IRB) and to any other country-specific authority/body after Regulatory Project Lead/Manager approval.• Serve as local expert in project startup activities for a particular country or region.
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  • Pra Health Sciences
    In House Cra Ii
    Pra Health Sciences Nov 2015 - Sep 2016
    Blue Bell, Pennsylvania
    ▪ Lead and coordinate activities that ensure quality, consistency, and integration of study data and progress, assess operational deliverables to time, cost, and quality objectives from Study Specifications (SS) through study close-out activities and Clinical Study Report (CSR)▪ Interface with data management representatives to facilitate the delivery of study data▪ Ensure the supply of study materials and Investigational Product (IP) by liaising with Investigational Product Supply or external service providers as appropriate▪ Lead the preparation of country specific agreements, confidentiality agreements, clinical trial applications and aid in the development of the source data verification plan and other application operations documents▪ Perform investigator recruitment activities utilizing phone scripts, questionnaires, study site materials and other tools for use in evaluating investigator sites.▪ Utilize Clinical Trial Management System (CTMS) to ensure investigator recruitment activities are accurately tracked▪ Process and collect essential documents, review maintenance and close-out activities, ensuring that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH/GCP guidelines▪ Support investigators and investigator staff in fulfilling obligations with regard to local submissions according to local regulatory and Institutional Review Board (IRB)/Independent Ethics Committee (ICE) requirements▪ Perform study tracking via CTMS or sponsor designated system to ensure that the study files are current, accurate and complete▪ Document site and sponsor contact and study interactions in a timely and professional manner.▪ Proficient in the development and review of Informed Consent Form templates▪ Provide timely status reports for the clinical activities on assigned projects▪ Determine, track, and review milestones, tasks, timelines and project
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  • Inventiv Health Clinical
    Clinical Research Associate
    Inventiv Health Clinical May 2013 - Nov 2015
    Philadelphia, Pennsylvania
    Assists the CPM and LCTMS with: • preparations of recruitment projection and country and site selection • direct and indirect fees • study team meetings and collaborates with other Teva functions such as Pharmacvigilance, Medical Affairs, Marketing, Regulatory etc. • Assists in managing the meetings with the CRO at the study level • Assists in ensuring the study related manuals are completed and revised as needed • Assists in ensuring accurate and timely payment of invoices to the CRO and vendors • Assists in planning investigators and kick-off meetings • Assists in ensuring that all essential documents are present in the TMF • Any other task assigned by direct manager
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  • Astrazeneca
    Csa - Impact Adminstrator
    Astrazeneca Jun 2014 - Oct 2014
    Wilmington, Delaware
    Integral member of a multi-functional team responsible for the implementation and maintenance of an International Clinical trial with over 17,000 subjectsManage multiple International countries and all the involved investigational sites and vendorsSupport Clinical Trial Manager in review of clinical trial protocol, CRF and supporting documents authored by study physician, database manager and IP managerWork closely within study delivery to manage and execute all operational aspects of a clinical trialWithin International – collect high quality critical documents and completion of Ethics Committee materials in preparation for regulatory submissions as applicableWork closely with data management and field operations to manage ongoing data retrieval from sites and resolve data issues to include queries and DCFs Manage IVRS vendor and IVRS Web Portal for US sites and International sites while working diligently to monitor site activity, drug supply, shipment history and drug reconciliationPrepare and disseminate project status reports to study delivery lead, investigators and vendors as neededEnsure timely entry and/or update appropriate information into tracking and communication tools (e.g., IMPACT)
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  • Gsk
    Monitor Csa
    Gsk Feb 2013 - May 2014
    Creation of new site center weeklyAssociate new CRAs to new center assignmentsUpdating weekly resources and confirm in etrackFollow new site assignments thru completion including update request via emailUpdate monthly site trackerEffort tracker reportingUpdate training records for Oncology CRAsPost Oncology monitoring files to team sitePull etrack data and reports for audits and FDA inspections
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  • Joule Inc.
    Clinical Trial Coordinator
    Joule Inc. Jan 2012 - Dec 2012
    Malvern, Pa
    Supported the Clinical Trials Managers with their assigned clinical trialsManaged the set-up, maintenance and archiving of Trial Master File documentsCreated an EDC in Microsoft access which all data is entered into the databaseCreated a validation plan for the Microsoft databaseCreated the requirements specification for the Microsoft database Created an summary report for the EDC Microsoft databaseData EntryManaged the set-up, maintenance and archiving of Trial Master File documents Supported and assisted with study site management, including liaising with site staff Assisted with shipping, inventory of study suppliesEstablished and maintained file systemsChecked the accuracy and completeness of the case report forms (CRF) entries, source documents and other trial-related records against each otherVerified that the data required by the protocol were reported accurately on the CRFs and were consistent with the source documentsVerified that source documents and other trial records were accurate, complete, kept up-to-date and maintainedFiling and maintaining CN documents Maintain training records for QA in SharePointUpdating and Uploading training documents for employees in QAMaintaining QA documentation in SharePoint
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  • Csl Behring
    In House Cra
    Csl Behring May 2010 - Dec 2011
    Manage Phases I, II and III studies from startup to closeouts study documents (e.g. protocol, CRFs, forms and manuals) and presentation material and assisted with IRB submission preparation. Managed the set-up, maintenance and archiving of Trial Master File documents and shipping of inventory and supplies. Helped with the BLA submission for Factor XIII, also entered monthly actual for the GTMs (Global Trial Manager) Therapeutic Area/ Indication /Lab Experience• Infection Diseases, Phase II & III, US and Europe• Hematology, Phase II & III, US, UK, Canada, Asia etc.
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  • Johnson & Johnson
    Gtm - Cta
    Johnson & Johnson Mar 2008 - Mar 2010
    Wayne, Pennsylvania
    • Phase I, II and III studies to ensure that the current versions of the trial documents and all required trial-related materials and supplies are provided to the study team • Supported the GTM (Global Trial Manager) in collecting and tracking IFDFs, 1572 forms throughout the trial and all communications related to study closure and followed up of all items identified and non-US countries • Supported the GTM (Global Trial Manager) and provided support to GTM (Global Trial Manager) in tracking of progress of the trial; management of study data; budget; organizing meetings; mailing documents and supplies: travel arrangements and processed expenses; collecting and processing feasibility; and correspondence and other relevant tasks as appropriate• Maintained the tracking of regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission and data query generation and resolution. • Study start on Castleman disease for local and global sites• Created and forwarded site list to eCRF provider• Maintain Adverse Event/Safety Adverse Events case reports from other countries received thru the SAE email box. Write up report letters from the SAE Case reports with the code of the events. Data capture events that are not entering on the reports. Follow ups on SAEs/AEs• Upon receipt of each country's List of Investigators and IRBs/IECs, merge the documents into one listing and forward to the GTM (Global Trial Manager)• Maintained and updated site demographics on computer database; logged forms received and file as appropriate; prepared reports from data base to include weekly reports and other reports as requested• UAT testing • Maintained trial contact list; Maintained and reviewed data gateways – IVRS, Labs• Reviewed CTMS Portal for completeness; Created and maintained tracking systems – feasibility, site assessments, protocol deviations etc. Review and submit CTA’s for PI’s
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  • Pfizer
    Administrative Assistant
    Pfizer Mar 2006 - Mar 2008
    King Of Prussia, Pennsylvania
    • Prepared correspondences, reports, documents and/or other written materials• Updated SOP books in the department• Maintained and created files and budget record keeping; sorting, labeling, filing and retrieving documents, or other materials• Entered data results in LIMS (Operation of Quality and Stability Modules), which included but not limited data, stability, water results and sample results
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  • Silk Abstract Company
    Post Closing Coordinator
    Silk Abstract Company Nov 2005 - Mar 2006
    • Maintained company documents for borrowers; reported any changes that the borrowers may have had in order to process information to be disbursed• Requests or approves amendments to or extensions of contracts• Processed wires, payoffs, title polices and lien releases• Send signed documents to lender and to be recorded
  • Bayard Sales Corporation
    Financial Associate
    Bayard Sales Corporation Nov 2004 - Nov 2005
    • Assigned to special projects for the CFO• Worked in MPAS database to track and update pricing and tax information• Typing, filing and creating metrics financial analysis reports
  • Pegasus Communications
    Marketing Coordinator
    Pegasus Communications Jul 2003 - Nov 2004
    • Prepared routine and advanced correspondences to including confidential letters, memoranda, and reports; Performed in an administrative support capacity to coordinate customer visits; ensured optimum customer readiness of meeting rooms, equipment, and hospitality. Prepared and input bills, vouchers and expense reports in People soft; Prepared and maintained calendars for more efficient scheduling; Monitored and ordered supplies, handled real estate issues and electronic event scheduling.
  • Verizon
    Marketing Coordinator
    Verizon Sep 1999 - Aug 2002
    • Prepared routine and advanced correspondences to including confidential letters, memoranda, and reports; Performed in an administrative support capacity to coordinate customer visits; ensured optimum customer readiness of meeting rooms, equipment, and hospitality. Prepared and input bills, vouchers and expense reports in People soft; Prepared and maintained calendars for more efficient scheduling; Monitored and ordered supplies, handled real estate issues and electronic event scheduling.
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  • Mutual Pharmaceutical
    Documentation Specialist
    Mutual Pharmaceutical Jul 1992 - Jul 1998
    • Collection, maintain and distributes all documents necessary to define product configuration and control manufacturing processes that insure conformance to customer requirements; develops and maintains a comprehensive filing system and computer database for all documents to be retained in the document control center; manages the operation of the document control center to ensure that all users have the latest revision of appropriate documentation in a timely manner.
  • Smithkline Beechman
    Clerical Research Secretary
    Smithkline Beechman Nov 1989 - Jul 1992
    Supported 4 onsite Renal PI’s at Presbyterian Hospital Smithkline Beech department. Follow up on subjects with payments for participating in trial studies.Therapeutic Area/ Indication /Lab Experience• Renal, Phase I & II, US onlyKey areas of Responsibility• Dictation transcription • Correspondence • Assisting physicians with medical research • Recording medical history of study subjects • Ordering of medical supplies • Coordinating with insurance companies • Coordinating with labs for patients results

Cleo James Skills

Administrative Assistance Organizing Meetings Academic Research Retrieval Supplies Cards Clinical Trials Books Shipping Adobe Acrobat Payments Expenses Vendors Edx Sales Infectious Diseases Contractual Obligations Clinical Research Medidata Ctms Regulatory Affairs Finance Digital Preservation Correspondences Collecting Site Management Machinery Trims Closeout Nda Tracking Systems Deviations Legal Windows Xp Clinical Operations Organizational Structure Direct Mail Assessment Regulatory Compliance Disease Closure Microbiology Edc Ecrf Databases Pain Management Management Design Iop Feasibility Studies Computer Science Science Therapeutic Areas American Express Sop Icon Initiation Resolve Committees Pfizer Sorting Office Equipment Iec Powerpoint Monitors Clinical Practices Source Ethics Dedicated Professional Sharepoint Respiration Liaising Approvals Follow Ups Execution Informed Consent Factor Cardiovascular Cros Gmp Gastroenterology Sae Web Applications Entry Legal Writing System Manuals Languages Validation Reports Hermes Cvs Template Internet Protocols Agreement Inventory Gtm Microsoft Office Clinical Support User Acceptance Testing Microsoft Excel Oncology Gcp Training Ariba Bookkeeping Patient Status Reports Enterprise Software Gcps Regulatory Submissions Supply Beacon Project Management Quality Control System Monitoring Reporting Srm Pop Investigation Microsoft Lims Trackers R&d Written Radiographic Testing Laboratory .net Multi Functional Coordination Voip Lync Fix Protocol Query Writing Logistics Accountability Adverse Events Intralink Communication Schedules Iv Data Verification Clinical Research Associates Gps Pds Quality Assurance Crfs Safety Operations Triage Icf Microsoft Access Interactive Advertising Travel Arrangements Maps Queries Dsl Project Planning Sap Xi Documentum Project Contractual Agreements House Facilities Management Drug Safety Consent Aes Inventory Control Pivotal Presentations Batch Records Cras Case Report Forms Cta Websites Responsibility Manage Multiple Computron Clinical Staffing Phoenix Regulations Labelling International Peoplesoft Phase Forward Inform Portals Data Management History Lotus Notes Start Ups Forms Irb Reviews Electronics Ich Guidelines Guidelines Materials Medical Devices Business Objects Outlook Field Operations Acm Ivr Pharmacovigilance Phase Microsoft Word Requirement Specifications Stocks Subjects Qualify Manufacturing Business Object Stability Delivery Operations Vaccines Budgets Rave Central Nervous System Analgesia Filing Delivery Women's Health Fda Recruiting Business Travel Coordinate Dbms

Cleo James Education Details

Frequently Asked Questions about Cleo James

What company does Cleo James work for?

Cleo James works for Fortrea

What is Cleo James's role at the current company?

Cleo James's current role is Associate Project Manager I, Start-up.

What is Cleo James's email address?

Cleo James's email address is cm****@****aol.com

What is Cleo James's direct phone number?

Cleo James's direct phone number is 161077*****

What schools did Cleo James attend?

Cleo James attended Arizona State University, Kaplan University, University Of Phoenix, Kaplan University, Spelman College.

What skills is Cleo James known for?

Cleo James has skills like Administrative Assistance, Organizing Meetings, Academic Research, Retrieval, Supplies, Cards, Clinical Trials, Books, Shipping, Adobe Acrobat, Payments, Expenses.

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