Study Coordinator, Kit Production

Location: Frederick, Maryland US

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Job Id: 5534

Position Title: Study Coordinator, Kit Production

External Description:

Play a critical role in helping patients gain access to the treatment they need. This position is responsible for specimens in our state of the art facility that have been collected by our clients who are managing clinical trials to secure the required approval for potentially life-saving patient treatments. Clinical trials depend on biological specimen samples being withdrawn and deposited on a continual basis.

Our Biorepository facility currently houses over 25 million specimens. The Study Coordinator will manage the process of creating, auditing, and approving Kit Production related documents to support Global Research Studies. This role with function under general supervision to represent the Kit Production team and facilitate the pre-planning logistical efforts in collaboration with Project Management.

Essential functions of the job include but are not limited to:

  • Work collaboratively with the Project Management Team to support the creation of Study Specific Laboratory Instruction Manuals or Flowcharts
  • Act as the Subject Matter Expert (SME) and fully understand the Laboratory Manual/Flowchart in order to create Study Specific Documents
  • Create and Audit Kitting Documents which may include Checklists, Requisition Forms, Packing List, Commercial Invoices, Inventory Supply Forms, Kit Label Files and the Laboratory Manual
  • Amend and update documents as required with authorization of the Project Manager
  • Participate in Client calls as an Observer, as necessary

Other Duties include

  • Work closely with the Receiving Team to facilitate the Raw Materials Process to bring supplies into Production for the use in Kits
  • Lead all efforts for Kit Production Inventory Management
  • Support Periodic Review of Kit Production documents through our Quality Management Process
  • Generate and track established Key Performance Metrics for Kit Production
  • Other duties as assigned

Qualifications:

Minimum Required:

  • Associates Degree or equivalent combination of education and experience
  • 2 years of lab/repository experience with government contracts, commercial services or in product development

Other Required:

  • Must have excellent organizational skills with the ability to manage multiple tasks and interact effectively with multiple departments and levels internally as well as externally
  • Ability to work under pressure, multi-task at a high level and meet tight deadlines; exercise judgment within generally defined practices and policies; work independently and take initiative
  • Must possess strong computer and business writing skills
  • Experience with Microsoft Office
  • Excellent communication, interpersonal, organizational and multi-tasking skills required
  • Excellent use of judgment and discretion
  • Professional and mature emphasis on Client Service and project delivery
  • Possess proven track record of being a team player, willing to interact proactively and productively at times independent of the Project Manager
  • Ability to communicate with personnel across diverse technical and business backgrounds both internally and externally
  • Ability to assume additional Duties as necessary to enhance the contributions of this role
  • Must be able to read, write, speak fluently and comprehend the English language

Preferred:

  • Bachelor’s Degree

Division: Precision For Medicine

Business Unit: Specialty Lab Services

Office Based: Frederick - 8425 Precision Way, Suite M, Frederick MD 21701

Employment Type: Exempt

Employment Status: Regular Full-time

Work From Home Available:

City:

Country: United States

State:

Community / Marketing Title: Study Coordinator, Kit Production

City: Frederick

State: Maryland

Country: United States

Company Profile:

Precision Medicine Group is an integrated team of experts in fields from advanced lab sciences to translational informatics, clinical trial delivery, and regulatory affairs, payer insights to marketing communications. Together, we help our pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.

EEO Employer Verbiage:

Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2020 Precision Medicine Group, LLC

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.

Location_formattedLocationLong: Frederick, Maryland US

Precision Medicine Group is an integrated team of experts in fields from advanced lab sciences to translational informatics and regulatory affairs, payer insights to marketing communications. Together, we help our pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.

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If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.

© 2018-2020 Precision Medicine Group, LLC. All rights reserved