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CRA II / Senior CRA

Boston, MA 02180

Posted: 10/04/2023 Employment Type: Direct Hire/Perm Job Category: Clinical Development and Operations Job Number: 588293 Is job remote?: No Country: United States

Job Description

Target Pay Rate: 70-120k **salary will be commensurate with experience 

Main Job Tasks and Responsibilities:

  • Keeps professionally abreast of all scientific, regulatory, and operational aspects relevant to the clinical projects assigned
  • Assists in the selection of sites, site evaluation visits, initiation visits, and ensuring follow-up by obtaining the pre-study documentation to ensure good start-up of the investigation sites
  • May act as Feasibility Associate after appropriate and documented training
  • Performs training site staff in all study procedures in order to ensure protocol/ICH-GCP compliance
  • Conducts and reports periodic monitoring visits in the field and reviews at each visit accuracy, legibility, completeness, and quality of the Case Report Form (CRF) in compliance with the protocol, SOP's and ICH-GCP requirements in order to ensure data integrity and subject safety
  • Conducts source data verification and in-house review of clinical data and ensures timely resolution of data queries to guarantee reliable clinical data
  • Manages the investigational products (storage, inventory, dispensing records, packaging, and labeling) and the trial material (Investigator study file (ISF), CRF, questionnaires, diaries, etc.) to ensure timely and correct supply to the site
  • Cooperates with the site staff for ensuring proper reporting from the site of the safety issues (such as AEs/SAEs, SUSARs, etc.) and their follow-up, guaranteeing timely and appropriate handling of safety issues
  • Conducts and reports study termination and related activities (e.g. archiving) guaranteeing smooth completion of the project
  • Will be the main contact person for the site in order to ensure close follow up
  • Provides general support to the Clinical Research Division on quality control of clinical data
  • Promptly address the Projects Coordinators/ Project Managers/ Senior Project Managers about any issues that can jeopardize the conduct of the clinical projects assigned
  • Reports to the Head of Clinical Monitoring Unit on all activities performed during the study and sends all relevant documents according to the timelines and the requirements agreed for each single clinical trial
  • Develops training material and gives training in collaboration with the Training & Qualification Management Unit
  • May assist in contract negotiation with sites on study budget after appropriate and documented training
  • Assists the preparation of the study including CRF design/development, writes CRF instructions, and organizes the study files and documents to ensure good start-up of the investigation sites
  • May support the submission process in the project (or region), including submission requirements, timelines, informed consent development, etc. after appropriate and documented training.
  • Guides and supervises Clinical Research Associate I (CRA I) in order to coach and train them on the job


Education and Experience:
  • University Degree in scientific medical or paramedical disciplines
  • Previous proven experience as a CRA, performing on-site monitoring activities
  • Strong knowledge of clinical trial operations, GCP/ICH Guidelines, and other applicable regulatory requirements
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