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.
Essential Duties & Responsibilities
· 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.
Education & Work Experience