Post Job Free

Resume

Sign in

Project Clinical Research

Location:
United States
Salary:
66000
Posted:
May 24, 2016

Contact this candidate

Resume:

TRACY L. BELL

Hasbrouck Heights, New Jersey *****

Email: acuxc2@r.postjobfree.com

Linked in profile: https://www.linkedin.com/in/tracylbell

CAREER OBJECTIVE

Obtain a challenging position as a Project Coordinator or Clinical Research Associate where I can apply my leadership, organizational and communication skills, as well as my knowledge, experience and expertise to bring projects and project leads to fruition in diversified industries.

SUMMARY

Project Manager and Clinical Research Associate: solutions-driven professional, offering more than six (6) years of experience within various industries specializing in project submittals and project completion from onset to finish. Organizational and Management abilities demonstrated in the smooth running of departments for Vice Presidents, BA Executives, Medical Executives, and Project Managers. Participated in FDA submission of protocol, identification, evaluation and selection of clinical investigators, Quality reviews for Clinical Study/Trial Reports and FDA briefings. Core competencies include:

Monitoring project plans, deadlines, submittals and schedules.

Maintaining proposal process and data through Salesforce and CRM.

Reviewing project plans and pending awarded projects.

RFP Development from start to finish through contract execution.

TECHNICAL SKILLS

Microsoft Office (i.e., Excel, PowerPoint, Outlook & Word), Microsoft CRM, SharePoint, Salesforce, Concur Expense System, Adobe Acrobat, PDF Converter, Web-page Design, Quick Expense Enterprise, Cliqbook, Application software and Microsoft Project.

PROFESSIONAL EXPERIENCE

T-Mobile USA, Inc. May 2015 – Present

Project Manager / Legal Affairs

Utilize SharePoint, Microsoft Project, & Excel for documenting and tracking project deliverables.

Assisted in development and maintenance of the project process, templates, using SharePoint, and Microsoft Project.

Prepared and maintained spreadsheets for follow-up and project review in Excel.

Coordinated the development of proposals using Microsoft Office and Microsoft Project.

Scheduling weekly meetings and preparing agenda to include in weekly project calls.

Preparing and editing correspondence, reports, meeting notes and presentations.

Updating and submitting project review docs in SharePoint.

Manage projects and conduct research for documentation needed.

Document control and tracking project activity in project timelines.

Maintain document control, database management, track project activities and team communication.

Schedule project follow up meetings as needed.

Effectively manages time to meet project deliverables and crucial deadlines.

Develops and publishes communications to project shareholders.

Time Warner Cable Business Class, New York, NY February 2014 – October 2014

RFP Specialist/Project Coordinator (Consultant)

Utilize SharePoint, Microsoft Project, & Excel for documenting and tracking project deliverables.

Assisted Sales Account Executives and project engineers in planning, outsourcing and organizing sales proposals across the sales division in CRM’s functionality.

Coordinated the development of proposals using Microsoft Office and Microsoft Project.

Maintained records of proposal status and changes and continuously distributed pertinent information to Account Executives, supervisors and others involved in proposal development.

Kratos Defense & Security Solutions, Fair Lawn, NJ May 2011 – December 2013

Sales/Project Coordinator

Worked with sales and engineering departments to ensure that bid proposals, marketing materials and project submittals met customers’ requirements.

Assisted in development and maintenance of the proposal process, templates, and tracking of pending and awarded projects using SharePoint, Microsoft Project and CRM.

Maintained records of proposal status and changes and continuously distributed pertinent information to Account Executives, supervisors and others involved in proposal development.

Prepared, developed and tracked the proposal process, binder completion, and submission.

ITT Industries, Clifton, NJ May 2006 – April 2011

Business Dev/Project Coordinator (Consultant)

Supported eight Managers within the Business Development department to successfully execute their sales and marketing projects.

Maintained calendars and event planning; prepared mailings through mail merge for all marketing events in Microsoft Excel.

Maintained expense charges/payments (Concur software expense system).

Created and tracked various protocol and government information through excel spreadsheets.

Assisted in coordination and development of RFP responses for government agencies.

Assisted in development and maintenance of the proposal process, binder completion and submission.

Created presentations for Business Development Reviews and or executive meetings.

Maintained and updated Proof of Delivery documents for submission and review.

Daiichi Pharmaceutical Corp. Montvale, NJ January 2002 – March 2006

Clinical Research Associate (Anti-Invectives & Global Business Development)

Participated in FDA submission of protocol, identification, evaluation and selection of clinical investigators, Quality reviews for Clinical Study/Trial Reports and FDA briefings.

Primary liaise to vendors; Clinical Research Organizations, Consulting Firms, Clinical Investigators.

Prepared presentation materials (from CRO-Clinical Research Organization) for project managers and senior management project related meetings.

Participated in the IND (Investigational New Drug) submission that contributed to the successful Floxin Otic (Ofloxacin Otic Solution) NDA approval.

Managed and revised study protocols and regulatory documents for the studies.

Created, managed and organized as the TMF (i.e., Curriculum Vitae, Medical Licenses, Institutional Review Board (IRB), Financial forms, Protocols and Laboratory Certifications).

Tracked, prepared and maintained medical/laboratory electrocardiogram data.

Maintained and tracked Medical terminology based upon specific study and drug information.

Prepared “Confidentiality Agreements” and maintained executed agreements (legal intake forms).

Prepared and arranged travel itinerary; processed expense reports and reimbursements for meeting attendees and mailed payments from a Microsoft Excel created database.

Prepared and shipped offsite Meeting materials (i.e., invitation, letters, name badges, tent cards, agenda and binder materials).

Managed and supervised Investigator Meetings (i.e., registration, reception and all meeting preparations).

Confirm the accuracy of the study data based on subject enrollment.

Liaises fully, with other functional areas on study-related processes.

ICF (Informed Consent) Documentation Review for study participation.

Updated and entered Quality reviews for Clinical Study Reports and FDA briefing book.

Receive, review, track/inventory and filed all documents pertaining to applicable clinical research studies.

EDUCATION

B. A. coursework in Communication, to be completed December 2016

Certificate of Completion, Transitioning to Green Career Program,

Fairleigh Dickenson University, February 2015



Contact this candidate