PROFESSIONAL EXPERIENCE

Harvestaff, contracted to Bayer Radiology, Labeling Specialist 2022- present

Supported TechPubs Group – fully remote position

V&V of produced labels, box artwork and IFU

Take part in LDR meetings

Send documents to team for review/approval

Use of Enlabel, Windchill and Microsoft Office software

Performed all training programs as requested

Handled special projects as requested

Hydro Aluminum Extrusions, Cressona, PA, Administrative Assistant 2020-2021

Support Extrusion Department

Ordered office supplies, PPE supplies, furniture, and other items as requested

Prepared requisitions for approval by senior staff

Prepared daily reports for department head

Tracked new personnel reviews, overtime sign ups, etc.

Prepared Administrative Assistant Handbook for Department

Interfaced with Supervisors & leads to meet the needs of all team members on 4 shifts

Able to effectively prioritize tasks and assignments to meet long and short-term deadlines

Strong work ethic and willingness to take ownership for wide-ranging responsibilities

Completed projects (working independently) as assigned

Assisted with Companywide Inventory

Assisted other Admins and Departments upon request

Niagara Bottling, Hamburg PA, Shipping Associate 2019 – 2020

Hydro Aluminum Extrusions, Cressona PA, Data Entry & Admin Assistant 2020 - Present

Prepared and printed load paperwork; interfaced with truck drivers (using my experience growing up in a trucking family) and warehouse personnel to meet shipping deadlines

Verified trailers in specific dock doors for loading

Assisted with inventory

Completed projects as assigned

Provided directions in person or over the phone to drivers looking for warehouse, lodging, food, fuel, scale, etc.

Assisted with clean up following palletizer failure, dropped loaded pallets, etc.

Attended all scheduled pre shift meetings

Confirmed trailers in yard, trailer #s and locations

Interfaced with shuttle vendor and drivers to maintain the flow of inventory

HerbalRue, Hamburg, PA 2019 - Present

Freelance/Consulting

Assisting client (small herbal companies) to become FDA Compliant

Remote/Home Based position requiring collaboration, prioritization, communication skills, organization and the ability to work independently

CFR Title 21 (multiple parts – dietary supplements, food products, cosmetics, drugs, etc.)

Quality Assurance (freelance for herbal company)

Crafting/updating of 80+ SOPs (administrative, personnel, equipment use, GMP, quality assurance, record keeping, business-specific, etc.)

Drafted Quality Assurance Plan, Quality Control Plan and Code of Ethics

Handled vendor qualification, vendor management and NDAs

Acted as liaison between company and Department of Alcohol, Tobacco & Firearms as well as the State of Oregon Liquor Control Commission and US National Park Service.

Set up testing program of post-manufactured tinctures as required under CFR Title 21 Part 111

Innovation Pharmaceuticals (formerly Cellceutix Corporation), Beverly, MA (remote)

Manager, Clinical Operations 10/2013 – 1/2018

Assisted with CTIX-BRI-204 Phase II ABSSSI Clinical Trial; 4 sites; 215 subjects; positive results

Managed the CTIX-BRI-205 Phase II Oral Rinse for Oral Mucositis Clinical Trial from Concept/ Protocol to DBL (38 months); 18 sites; 61 randomized subjects (head & neck chemo/RT patients); ~30.5% withdrawal rate; primary & secondary endpoints met (CSR still pending)

Study Manager, responsible for oversight of operational study deliverables, and day-to- day study operations and administration.

Remote/Home Based position – required ability to prioritize tasks, work independently, and heavy focus on communication, organization and collaboration

Therapeutic Experience: Anti-Infectives, Oral Mucositis

Assisted with creation & presentations of materials for Site Initiation Visits

Assisted with preparation and made input to Investigator Brochure, Clinical Protocols, Informed Consents, manuals and forms needed for clinical trials

Management of all vendors including those for clinical supplies for trials as well as hotel & travel vendors for potential investigator meetings; also reviewed & approved trial invoicing

Responsible for overall IRB submissions for oral mucositis study with central IRB

Made site visits as part of the team conducting SIVs, also made follow up visits to sites both trials)

Supervised in-house unblended pharmacy monitor including review/approval of expenses

Over-saw roll out of ClinTrialApp (unique opportunity for collaboration with app creators) for Oral Mucositis study; responsible for updating documents & other information in app

Acted at TMF Process Owner assisting w/resourcing, unitization and oversight of the Trial Master File system; also supervised Clinical Trial Associates (TMF Specialists) responsible for TMF, maintenance & reorganization of Beverly locked file room

Organized, procured, stored and tracked expenditures of clinical supplies for Oral Mucositis trial

Oversaw consultant responsible for shipping clinical supplies

Worked with vendor responsible for packaging, storing & shipping drug product to keep sites supplied at all times

Assisted with preparation of electronic documents for FDA submissions

Focused on research and trial compliance with CFR/FDA rules and regulations

Assist with compiling hybrid paper/electronic submissions to FDA including preparing desk copies (as needed) & shipping to FDA; also burned & tested CDs for submissions

Responsible creating and maintaining for all submission documents

Assisted with compilation, preparation of & submission of IND for Oral Mucositis

Completed GCP Training

Member of ABSSSI & OM Phase II study teams, attended team meetings, conference calls, etc.; responsible for purchase, storage & shipping of all clinical study supplies.

PolyMedix, Inc. Radnor, PA 3/2010 – 4/2013

Executive Assistant – supporting Clinical Operations/Regulatory Affairs (Clinical Research) and Research Teams

Performed key Executive Assistant as well as the following:

Participated with compilation of Common Technical Document (IND for ABSSSI)

Was assisting with compilation and preparation of IND for Oral Mucositis

Assisted with preparation and submission of Briefing Book for scheduled FDA Meetings

Assist with preparation of electronic documents for FDA

Assist with compiling paper submissions to FDA including preparing multiple copies & shipping to FDA; also burned & tested CDs for submissions

Assisted with preparations for Due Diligence by potential investors

Responsible for uploads and removal of electronic documents in data SmartRoom; also providing access to viewers; maintaining order within the room

Assisted with preparation of Investigator Brochure and Clinical Protocols

Assisted with contract negotiation of vendors for clinical supplies for trials

Organize Investigator Meetings (contracts to travel) and other meetings as needed (internal & external) including budget tracking, attendance, vendor management, purchase of meeting supplies & incentives, etc.

Able to effectively prioritize tasks and assignments to meet long and short-term deadlines

Strong work ethic and willingness to take ownership for wide-ranging responsibilities

Completed projects (working independently) as assigned

Provided support to both the President and CFO of PolyMedix in the absence of their respective assistants

InVentive/MedFocus 3/2009 – 3/2010

Contract assignment at GSK Bio – supporting Procurement (King of Prussia, PA)

Performed key Executive Assistant as well as the following:

Scheduled meetings and presentations

Liaised with vendors for proposals

Prepared contracts and confidentiality agreements

Followed up with study teams about contract management

Performed tasks as requested by Director of Procurement & study support staff

Contract assignment at Wyeth – supporting Clinical Team (Collegeville, PA) 2009

Performed tasks as requested by team members & supervisory staff including coordinated with staff & team members in Cambridge, MA

Encorium Group, Inc. King of Prussia/Wayne, PA 6/2006 – 11/2008

Sr. Project Management Assistant

Supported Chief Operations Officer & VP of Clinical Operations

Also supported Project Management Teams and Business Development Group

Performed key Executive Assistant as well as the following:

Assisted QA/QC with scanning of documents and reports for electronic filing

Functioned as Feasibility Coordinator to assist Business Development to gather data to prepare bids and for bid defense utilizing TrialWorks/MS Word and Outlook (Therapeutic Experience: Oncology, Vaccines, Influenza, DVT, etc.)

Acted as meeting and special event planner (10 – 100+ persons) and all corresponding logistics in US and international (Finland);Multi-city/multi-country travel arrangements including air travel, hotels and ground transportation

Vicuron Pharmaceuticals King of Prussia, PA 11/2001 – 12/2005

Executive Assistant to Executive Vice President of Scientific Affairs

Supported Director of Supply Chain Operations

Managed the calendar for the EVP, Directors and other department members, including updating of contacts utilizing MS Outlook

Handled all invoicing, purchase orders and needs as requested by Accounts Payable

Tracked department budget (MS Excel) and was liaison to Finance Department (managed accruals; assisted with budgets preparation)

Managed preparation of all department meetings including room reservations, catering services, audio/visual aids, handouts, room supplies etc.

Multi-city/multi-country (US, Canada, UK, Italy) travel arrangements including air travel, hotels and ground transportation

Prepared expense reports including multi-currency as well as USD

Anticipated assistance needed by identifying problems, needs, options, and solutions before being asked

Able to effectively prioritize assignments to meet long and short-term deadlines

Process expense reports & monitored department expenses

Strong work ethics and willingness to take ownership for wide-ranging responsibilities

Covance (Radnor, PA) as an Admin Asst in the HR/Recruiting Department 1999-2001

IBAH (Plymouth Meeting, PA) as data entry clerk & Admin Asst in Data Management 1996-1999

EDUCATION:

Katherine Gibbs Secretarial School, Philadelphia PA 1981-1982

Graduate, Secretarial & Word Processing Program

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