JOB POSITION : Clinical Research Associate II Orthopedic & Spine

Date: 7 February 2012

Position Overview

This position is responsible for:

  1. Training and managing Investigators and clinical site staff for compliance to approved protocols and applicable regulations;
  2. Performing site visits to ensure the completeness and accuracy of data collection;
  3. Working to secure appropriate subject follow-up and safety through contact with site personnel;
  4. Maintaining regulatory files to include all required documents (including informed consents, IRB approvals, agreements, etc.); and
  5. Developing study-specific tools and procedures as well as site surgical coverage.

Responsibilities

Participates in all phases of clinical trial implementation, to include:

  • Investigator/site selection, training, and management
  • Clinical document development
  • Essential document review and handling
  • Presentation at Investigator and other clinically relevant meetings
  • Vendor selection
  • Enrollment activities
  • Site management and relationship development
  • Site Initiation, Monitoring, and Close-Out/Termination
  • In-house study file maintenance (e.g., site regulatory documents, patient/subject files)
  • Study-level product accountability
  • Study safety activities
  • Study product training
  • Surgical coverage

With management assistance, develops (portions of) clinical study budget and manages
within it. Develops study timeline and drives to meet milestones. Assists in management of
CRO(s) activities and provides regular progress reports. May perform other job related
duties, as assigned.

Experience

  • Work experience in a regulated environment, with preference given to pharmaceutical
    and/or biotechnology industry. Knowledge of the orthopedic and spine industry is
    desired, but not required. Minimum 3 years of prior work experience, including 2 years
    work in a clinical or clinical trial setting.

Education

  • Bachelor’s degree or nursing (R.N.) licensure required.

Specific Skills

  • Working knowledge of requirements of 21 CFR Parts 50, 54, 56, 312, and 314.
  • An ability to work successfully as an individual as well as within a team structure is
    required.
  • Attention to detail.

Supervisory Responsibility

  • No supervisory responsibility; however, this individual is responsible for managing
    clinical trial sites.

Working Conditions

  • Approximately 50-75% (annualized) travel required. Travel is at the discretion of the
    Director of Clinical Operations.
  • Strict adherence to regulations.
  • Fast paced, dynamic, and ever-changing environment.

Location

  • Austin, TX

This position will report directly to: Director of Clinical Operations, Orthopedic & Spine

Contact

jobs@mesoblast.com

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JOB POSITION : Clinical Research Associate II Orthopedic & Spine