In-House Clinical Research Associate

In-House Clinical Research Associate Job Description Template

Our company is looking for a In-House Clinical Research Associate to join our team.

Responsibilities:

  • Participates in development of departmental processes, SOPs, and initiatives;
  • Assists with design and preparation of study related materials for the training of internal and external staff;
  • Presents at team meetings as needed (i.e., Clinical Trial Team Meeting, Project Team Meeting, Investigator Meeting, project training, etc.);
  • Supports TMF set-up, maintenance, ongoing quality review, and final reconciliation of study documents;
  • Assists in development of study materials, case report forms (CRFs), informed consent documents for clinical studies;
  • Collaborates with the Clinical Trial Manager and/or the Clinical Project Lead on the development of certain study-specific plans and/or processes;
  • Participates in co-monitoring activities and oversight of CRO or contract field CRAs for pre-study, initiation, routine monitoring and closeout visits;
  • Helps facilitate resolution of data queries and requests from Clinical Data Management;
  • Develops and maintains good working relationships with Investigators and study staff;
  • Assists with the tracking and management of study specific budgets;
  • May assist with study entry and updates to ClinicalTrials.gov;
  • Contributes to the development of the Monitoring Plan and assists with ensuring appropriate quality and timely monitoring of clinical sites;
  • Keeps the Clinical Project Lead (CPL) informed of the progress of projects;
  • Acts as primary contact for study contractors (e.g., contract CTMs, field CRAs);
  • Assists in the organization and preparation of and participates in Investigator Meetings (as applicable).

Requirements:

  • Bachelor’s degree preferred;
  • Experience in scientific discipline and multiple therapeutic areas preferred;
  • Proficient in MS Office including Excel, PowerPoint, Word.

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