Clinical Research Associate (II), Rare Disease

Cambridge, MA, United States
Dec 17, 2020
Required Education
Associate Degree
Position Type
Full time
Clinical Research Associate (II), Rare Disease

Clementia Pharmaceuticals, Inc.

Job Description:

Are you looking for an opportunity to apply your clinical research monitoring experience in the rare disease therapeutic area?

As CRA II you will be responsible for overseeing, coordinating, and executing Phase I - III clinical study protocols while reporting to the Associate Director of Clinical Operations, Rare Disease.

Your role will involve:
  • Assist in the design and review of reporting forms, including Case Report Forms, and Informed Consent Forms, as well as other study-specific documentation
  • Perform Case Report Forms review and query generation and resolution against established data review guidelines
  • Manage trial supplies at investigative sites
  • Perform on-site and remote oversight of CRO monitoring
  • Identify critical data or potential gaps using a risk-based approach
  • Review and maintain the Investigator Site Files and the eTMF
  • Assist in the design and execution of clinical studies:
    • Site Selection
    • Plan Investigator's meetings
    • Conduct, or participate in, on-site training of investigative site staff, as assigned
    • Design monitoring tools
    • Conduct GCP monitoring visits at investigative sites (PSV, SIV, RMV and COV)
    • Assess CROs and other clinical research vendors
    • Act as primary project contact to external third parties and clinical site teams
    • Support and prepare investigative for potential Regulatory Audits

  • Manage project timelines and critical path activities
  • Help develop, communicate and manage Company standards and appropriate policies and procedures
  • Work with clinical teams to identify and resolve obstacles
  • Establish and nurture positive relations with project sites and team personnel
  • Perform other related duties as assigned
  • Approximately 30-40% travel required (globally)

In return, you will bring:
  • Degree or equivalent in health sciences
  • Minimum 5 years direct experience with Phase I - III clinical trials
  • Minimum 5 years of experience in on-site clinical trials monitoring
  • Working knowledge of regulatory requirements (FDA, ICH) including Good Clinical Practice principles and requirements
  • Demonstrated experience managing project teams and third-party contractors
  • Good knowledge of drug development key steps and actors

If this sounds like an exciting opportunity to employ your clinical monitoring experience on a small, global team, apply today!

IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.","datePosted":"2020-11-17T00:00:00.000Z