Job Details

  • Title: Study Management Associate
  • Code: RCI-09518
  • Location: North Chicago Illinois (IL) 60064
  • Posted Date: 09/25/2020
  • Duration: 6 Months
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  Job Description

Important Updates from the manager
  • PHD or MD degree will work if they are interested in this kind of role
  • CTMS experience is not a must have but definitely a help
  • Study coordinators will also be a good fit
  • Contractors will work from home for now
  • Currently have 6 therapeutic areas (Most need in oncology and immunology and neuroscience therapeutic areas)
  • 4 year degree needed (must have)
  • This is not a field CRA role
  • Position is over seen by study manager
  • This group runs phase 1-4 of clinical trials
  • Must be able to work as per CST (Must be flexible to take calls for Europe as Client is a global organization)
  • Running clinical trials
  • Position involves planning and executing clinical trials
  • This is very much study management associate role
  • Will entertain an RN with Associates degree (All other associate degree will not be considered)
  • Looking to hire 5 contractors
  • In house CRA will also be a good fit for this role
  • Clinical research background needed
  • eCRFs is a must have
  • Medical device background will work if they have good clinical trials experience (good study management experience)
Bachelor's Degree or OUR equivalent is required, typically in nursing or scientific field; or R. N. by Associate's Degree with relevant experience is acceptable.

Note: These could be LC based roles or remote for candidates with the adequate experience that they can work remotely with minimal support/guidance

Description:

Job title: Study Management Associate II/III (level depends on qualifications)
  • Competent in application of standard business procedures {Standard operating procedures, International Conference on Harmonization {ICH), Global Regulations, Ethics and Compliance).
  • Must have at least four years of Pharma-related/clinical research related experience and demonstrated a high level of core and technical competencies.
  • Possesses good communication skills.
  • Preferred exposure to study initiation through study completion.
Length of assignment: could vary up to 2 years…would expect minimum of 6 months, but likely 12 – 18 months, could go 2 years+

Job description:
  • Study Management Associates (SMAs) are responsible for supporting the planning and execution of one or more Phase 1 – 4 clinical research studies. An SMA performs clinical trial related responsibilities to ensure studies are executed with quality and efficiency, on-time, within budget and in support of company objectives.
Core Activities include:
  • Responsible for executing one or more elements of clinical studies in compliance with quality standards (ICH/GCP, Global Regulations, and policies and procedures).
  • Supports the Study Project Manager in leading the cross functional study team:
  • Supports the preparation of Clinical Study Team meetings (Agenda/Minutes)
  • Responsible for regular updates to the cross-functional team and stakeholders on study status; ensure our CTMS is up to date
  • Supports the development of the clinical study blueprint/protocol and associated systems and documents (Informed consent forms, eCRFs, IRT, CSR)
  • Supports the vendor selection, scope development, management and oversight of external vendors in compliance with processes and procedures and the applicable regulations.
  • Responsible for generating the study related training for the study team, study sites, and vendors for assigned studies
  • Proactively identify and resolve and/or escalate study related issues