Clinical Trial Specialist in Cambridge, Massachusetts at AccruePartners

Date Posted: 10/22/2019

Job Snapshot

Job Description

AccruePartners values our contract and consulting employees. We offer a competitive benefits package to meet the diverse needs of all of our contractor and consulting employees and their family members. Here is a listing of what our company offers: 401(k) Medical, Dental, Vision, Life Insurance, Employee Assistance Program, Medical and Prescription Drug, Short and Long-Term Disability Insurance. 

THE TEAM YOU WILL BE JOINING:

  • Industry-leading, bio-pharmaceutical company, listed top 40 of Global Innovation
  • Innovator in scientific breakthroughs and has been at the frontier each decade
  • Vision and passion around revolutions in biology for human health
  • Committed to their team, discovery, a sense of urgency, open culture, and best in class performance

WHAT THEY OFFER YOU:

  • Be a part of a committed and most forward-thinking team in their field
  • Work alongside a diverse and culturally aware environment with opportunities for employee development and networking
  • Year-round employee wellness programs and extensive employee health/safety programming
  • Community events that promote education, learning, and wellness along with arts and cultural institutions
  • Opportunity to collaborate on company-wide community service days and volunteerism

WHERE THIS POSITION IS LOCATED:

  • Cambridge, MA

WHY THIS ROLE IS IMPORTANT:

  • Responsible for study management and monitoring of assigned projects in accordance with SOPs, Good Clinical Practice, International Conference on Harmonisation (ICH) Harmonised Tripartite Guidelines, local regulations and additional sponsor requirements.
  • Participate in company, departmental and project team meetings.
  • Demonstrates study and clinical investigative site management according to Good Clinical Practices, ICH Guidelines, local regulations, and SOPs
  • Creates and provides input into study management requirements and tools, monitoring tools and manuals and training tools
  • Maintains thorough understanding of current monitoring practices and applicable regulatory requirements and guidelines
  • Performs study oversight and study site visits to ensure regulatory and study requirements are being fulfilled
  • Reviews study records including case report forms, consent forms, and other materials, and is versed in remote monitoring approaches
  • Serves as a resource to site coordinators, investigators, and other staff members regarding investigational products and protocols
  • Provides input, tracks progress, and works to implement corrective action plans for study and individual site recruitment and retention plans
  • Develops and maintains collaborative relationships with investigational sites study teams, CRO teams, and vendor teams
  • Produces quality and timely study documentation, including trip reports, tracking and site/sponsor communications in accordance with standard operating procedures
  • Maintains accurate and timely Sponsor/site communication and correspondence
  • Responsible for ensuring IMP and supplies accountability

THE BACKGROUND THAT FITS:

  • 3 years monitoring / CRO management or CRO oversight experience of clinical trials, including site management, or equivalent
  • Knowledge of ICH GCP guidelines and the expertise to review and evaluate medical data
  • Excellent written and verbal communication, problem-solving, and interpersonal skills
  • Strong attention to detail
  • Effective organizational and time management skills
  • Ability to travel up to 35%
  • Proficient with MS Office Suite (Excel, Word, and PowerPoint), familiar with MS Project
  • Minimum Degree Required: Bachelor's Degree