Alimera Sciences

R&D Associate

US-GA-Alpharetta
2 months ago(10/5/2017 12:34 PM)
ID
2017-1120
# of Openings
1
Category
Clinical

Overview

The Research & Development Associate will be responsible for receiving, documenting and responding to scientific inquiries regarding marketed products as well as tracking, filing, and maintaining clinical research documentation for ongoing and upcoming clinical trials.  The individual would work closely with Medical Information but also gain significant exposure with Clinical Operations as a supporting member of the R&D team. We are seeking a motivated individual with health care background to communicate scientific information in written and verbal format, maintain the Med Info database, and generate reports on a monthly basis.

 

Additionally, the individual will work with Clinical Operations to provide administrative support during all stages of the clinical trial process.  The individual would be responsible for updating and maintaining the Trial Master Files (TMF) as well as utilizing tracking and organizational tools to perform Quality Assurance (QA) of the TMF and ensure that the TMF remains compliant with Good Clinical Practice (GCP) guidelines. This individual will also contribute to defining the processes for maintaining the TMF.

 

Responsibilities

Essential Duties & Responsibilities

 

Medical Information

·  Handle incoming phone calls/ emails to process medical inquiries through the IRMS database as received from consumers and healthcare professionals.

·  Respond to medical information inquiries verbally or in written format in a courteous, professional manner with accurate and non-promotional information or escalate when deemed appropriate, accurate and non-promotional information.

·  Identify and triage those queries containing either adverse events or product quality complaints and handle these in accordance with the appropriate standard operating procedures.

·   Accurate recording of all medical communication transactions into the medical information database. Documentation is to be concise, thorough, and accurate.

·   Escalate all enquiries without predefined answers to a more specialized resource i.e., Assoc. Dir. Clinical Science.

·   Assist with Reporting metrics through the IRMS database.

·   Ability to summarize information when needed in written format in response to inquiries.

 

Clinical

  • Provide administrative support to Clinical Operations department
  • Assist with organization, distribution, filing and archiving of study specific documentation including International Council on Harmonisation (ICH) GCP essential study documents
  • Organize, maintain, and assist in quality control audits of the TMF
  • Assist in the set-up of clinical project meetings e.g. investigator meetings
  • Develop and maintain tracking spreadsheets with study level information
  • Support with creating and/or reviewing documents related to regulatory submissions, including Institutional Review Board/Ethics Committee (IRB/EC) submissions.
  • May be involved in budgets and finance administration and preparing invoices

Qualifications

Education & Work Experience

  • Bachelor’s degree or equivalent related health care experience (i.e. nursing). Ophthalmology experience is a plus.
  • Experience communicating scientific/medical information to health care professionals.
  • Educational/work background in a health care, nursing, clinical development, scientific or medical communications field.
  • Experience with software such as Word, Excel, Outlook and ACCESS. IRMS database experience preferred
  • Excellent active listening skills with courteous and effective verbal skills to respond to customers
  • Proactive, analytical and pragmatic approach to problem solving.
  • Ability to prioritize and show flexibility while meeting business needs.
  • Effective time management and organizational skills
  • Attention to detail and accuracy in work
  • General working knowledge of ICH Guidelines including GCP, governing the conduct of clinical trials

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