Clinical Research Associate

Our client is seeking a Clinical Research (Remote) to join their team. 

6 – 12 months plus
$25/hour

Individuals in this role work directly with research sites (doctors, nurses, and staff members) to collect the documents required to start up clinical research studies. Individuals utilize phone and email communication, are responsible for regulatory document and consent form review and data entry. Strong written and verbal communication skills, attention to detail and basic medical/therapeutic area and medical terminology knowledge are required. Systems utilized by this role are CTMS, Activate, Select, Veeva Vault eTMF, MS Teams, and Outlook Candidates can be located remote anywhere in the US.

Participates in the management and preparation, review and coordination of Country Submissions in line with global submission strategy.

  • Prepares, reviews and coordinates, under guidance, local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy.
  • Provides, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients.
  • Provides project specific local SIA services and coordination of these projects.
  • May have contact with investigators for submission related activities.
  • Key-contact at country level for either Ethical or Regulatory submission-related activities.
  • Coordinates, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation.
  • May work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable.
  • May develop country specific Patient Information Sheet/Informed Consent form documents.
  • May assist with grant budgets(s) and payment schedules negotiations with sites.
  • Supports the coordination of feasibility activities, as required, in accordance with agreed timelines.
  • Enters and maintains trial status information relating to SIA activities onto tracking databases in an accurate and timely manner.
  • Ensures the local country study files and filing processes are prepared, set up and maintained as per client’s WPDs or applicable client SOPs.
  • Maintains knowledge of and understand SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.

Education and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualification

 

#139010

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