WeymouthRecruiter Since 2001
the smart solution for Weymouth jobs

eTMF Coordinator

Company: Kelly Services
Location: Weymouth
Posted on: April 9, 2021

Job Description:

eTMF CoordinatorBoston MAHybrid Remote/Onsite--Role and Responsibilities

  • Under the immediate supervision of the eTMF Administrator, serves as coordinator of the electronic Trial Master File (eTMF)
  • Participates in the configuration and maintenance of the eTMF system, working closely and under the direction of the eTMF Administrator
  • Assists study teams with eTMF quality control and reconciliation of study documents to address documentation gaps--
  • Supports periodic reviews of the study eTMF per study plans
  • Assists the eTMF Administrator in retrieving reports necessary for assessment of eTMF metrics
  • Participates in preparation of eTMF audits of the Sponsor and site files
  • Provides ad-hoc eTMF system training to internal and external eTMF users
  • Addresses eTMF related support tickets submitted by eTMF users through the helpdesk system including eTMF troubleshooting----Qualifications and Education Requirements
    • Bachelor's degree and relevant work experience (pharma, biotech, CRO preferred)----
    • 1-2 years' experience in clinical trials (e.g., study coordinator, regulatory operations) and in eTMF document management experience preferred--
    • High proficient in MS Office suite (MS Office products, word processing, Excel spreadsheets, e-mail management and good etiquette)--Candidates must demonstrate the following competencies:--
      • Demonstrated working knowledge of GCP, ICH guidelines and FDA regulations, preferred--
      • Understanding of GCP and regulatory requirements as well as a working knowledge of clinical research documents that are maintained in the eTMF preferred
      • Familiarity with the eTMF Reference model and a demonstrated understanding of records management best practices preferred
      • Highly motivated with strong attention to detail and quality of work
      • Capacity to understand and analyze data/metrics--
      • Comfortable with technology and ability to learn new systems quickly--
      • Ability to analyze complex issues to develop relevant and realistic plans, programs, and recommendations--
      • Demonstrated ability to work independently and in a team environment
      • Communicate effectively, both orally and in writing
      • Strong organizational abilities and effective time management----Preferred Skills
        • Experience using the Wingspan eTMF clinical trial software------Why Kelly--?Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.About Kelly--At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world. Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.]]

Keywords: Kelly Services, Weymouth , eTMF Coordinator, Other , Weymouth, Massachusetts

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Other Jobs


Warehouse Attendant (Night Shifts Available)
Description: div style 'display:flex border:0px solid black important flex-direction:column ' div style 'display:flex width:100 ' div style 'flex:1 border:0px solid black important ' div class sfdc richtext (more...)
Company: Amazon
Location: Woonsocket
Posted on: 04/21/2021

Retail Sales Consultant PT Desert Hills Premium Outlets Cabazon
Description: Contribute to the sales profitability
Company: Swarovski Retail Ventures
Location: East Providence
Posted on: 04/21/2021

Warehouser (Night Shifts Available)
Description: div style 'display:flex border:0px solid black important flex-direction:column ' div style 'display:flex width:100 ' div style 'flex:1 border:0px solid black important ' div class sfdc richtext (more...)
Company: Amazon
Location: Woonsocket
Posted on: 04/21/2021


PT Retail Merchandiser Tampa, Fl Retail Execution East $11.75+/hr
Description: We are sure a lot of companies are trying to
Company: Retail Execution East LLC
Location: East Providence
Posted on: 04/21/2021

Licensed Life Insurance Independent Contractor - Work from Home
Description: Are you a Licensed Insurance Agent looking for a flexible opportunity One where you're provided with free warm leads Yes Then Liveops is looking for you Liveops is looking for Licensed Life and Health (more...)
Company: Liveops
Location: East Providence
Posted on: 04/21/2021

PT Retail Merchandiser Vicksburg, Ms Retail Execution East
Description: We are sure a lot of companies are trying to
Company: Retail Execution East LLC
Location: East Providence
Posted on: 04/21/2021

Retail Associate
Description: Job DescriptionPosition Purpose:Customer Service/Sales associates provide fast, friendly service by actively seeking out customers to assess their needs and provide assistance. These associates learn
Company: The Home Depot
Location: East Providence
Posted on: 04/21/2021

Retail Sales Consultant PT Natick Mall Natick, Ma Swarovski
Description: WHAT YOU CAN EXPECT You will work in
Company: Swarovski Retail Ventures
Location: East Providence
Posted on: 04/21/2021

Retail Sales Consultant PT Great Mall, Milpitas, Ca Immediate
Description: Contribute to the sales profitability
Company: Swarovski Retail Ventures
Location: East Providence
Posted on: 04/21/2021

PT Retail Merchandiser Muncie, In Retail Execution East [Apply]
Description: We are sure a lot of companies are trying to
Company: Retail Execution East LLC
Location: East Providence
Posted on: 04/21/2021

Log In or Create An Account

Get the latest Massachusetts jobs by following @recnetMA on Twitter!

Weymouth RSS job feeds