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Clinical Research Associate

Cambridge, MA

Posted: 08/30/2019 Employment Type: Contract Job Category: Clinical: Clinical Operations and Development Job Number: 2435

Our client seeks a motivated and enthusiastic clinical research professional who shares our passion for bringing innovative medicines to patients. The primary responsibility of the Clinical Research Associate (CRA) is to provide key support to the Clinical Operations Lead in study management activities and interface externally with Clinical Research Organizations (CROs) and vendors.

The CRA serves as our client' s primary contact with clinical investigators, may visit clinical research sites, and monitors site progress and Good Clinical Practice (GCP) adherence for Phase 1– 4 clinical trials. The CRA is responsible for overseeing the accuracy of all study documents at assigned sites and ensuring GCP is being followed by investigators and sites.

Responsibilities:
  • You will evaluate qualifications of clinical research sites with some guidance; oversee clinical trial investigator progress and GCP adherence through ongoing clinical trial field monitoring and reporting with some guidance.
  • You will participate in study team meetings providing frequent field monitoring updates; escalate site issues appropriately.
  • You will assist the clinical project teams in project related activities, such as creating study documents (e.g., source worksheets, patient advertisements); assist in the planning and preparation for investigator meetings.
  • You will assist with essential document tracking and filing; ensure completion of the study Trial Master File.
  • You will review and track clinical trial regulatory documents; work closely with Clinical Research Coordinators (CRCs) and CROs to ensure adequate clinical trial documentation, completion of telephone logs, notes to file, and status reports.
  • You will review and approve Clinical Monitoring Plans; work closely with CRO partners and CRAs to ensure compliance with Clinical Monitoring Plans.
  • You will monitor medical records and corresponding Case Report Forms (CRFs) for accuracy and completeness at clinical sites.
  • You may be responsible for some components of managing a vendor and study equipment.
  • You will interpret study Inclusion/Exclusion criteria.
  • You may mentor and train CRCs.
  • You will assist/lead development and implementation of policies and Standard Operating Procedures that pertain to job responsibilities within this clinical operations role.
  • You will be expected to have a strong knowledge of GCP and International Conference on Harmonisation (ICH) guidelines; work on problems of moderate complexity and of diverse scope; exercise judgment within defined practices and policies.
  • You will be expected to collaborate closely with clinical trial sites, Clinical Trial Managers, CRCs, cross-functional study teams, and CRO partners; complete assigned tasks within study teams and work collaboratively within study teams to achieve goals; work constructively within study teams and contribute to decision making processes.
     

Requirements / Qualifications:
  • Bachelor' s degree with 3 years of clinical research experience or equivalent. Prior field monitoring at a CRO or biopharmaceutical company. A minimum of 0-2 years of related monitoring experience.
  • Solid understanding of Microsoft Office products
  • Aptitude for organizational detail and demonstrated analytical skills
  • Capacity to complete tasks in a highly-regulated environment with minimal guidance
  • Flexibility to function well within a team environment and flexible to changing timelines and challenges
  • Ability to verbalize moderately complex study issues and demonstrated problem-solving ability
  • Strong understanding of FDA regulatory requirements and GCP

Sam Williams
Clinical Recruiter

Sam brings great enthusiasm and a passion for the life sciences to his role as Clinical Recruiter for The Steely Group. Outgoing and driven with a great sense of humor, Sam connects easily with people and prides himself on his ability to cultivate lasting relationships. He values honesty, communication and empathy in a candidate, and has a genuine interest in helping others achieve their professional goals.

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