Clinical Research Associate

Flexion Therapeutics – Boston, MA

Sound good so far? It really is!

We are inclusive, prize ingenuity, and are united by a common mission to rapidly advance transformative medicines for patients who cannot get them soon enough.

Our values focus, ingenuity, tenacity, transparency and fun form the fabric of the organization. They are reinforced daily and serve as key dimensions in the hiring process to help us ensure that Flexion is a magnet for outstanding talent and a great place to work.

Join our team as a Clinical Research Associate. This is a great opportunity to make an immediate impact and work at one of the Boston Globe s Top Places to Work 2017 AND 2018 and Boston Business Journal s Best Places to Work 2017 AND 2018!

The Role:
The In-House Clinical Research Associate (CRA) will report to the Director of Clinical Operations. The In-House CRA will work closely with the Clinical Operations Team in assisting with protocol feasibility, country assessment(s), site identification, patient recruitment, study monitoring, case report form development and study management. This position will interface with site coordinators, field clinical staff, Clinical Research Organizations (CRO), and other company representatives.

Responsibilities:

  • Participates in feasibility assessments, Investigator selection and site start-up activities
  • Participates in preparation of site and monitoring related trial documentation (e.g., consent forms, study manuals/forms, training materials, monitoring plans) as needed
  • Performs monitoring visits both independently and as a co-monitor to oversee the contracted CRA including site qualification, site initiation, routine monitoring and close-out visits in accordance with monitoring plans
  • Ensures site compliance with study protocols, GCP/ICH, applicable regulations prior to, during and following visits. Works with site personnel and study team to resolve issues
  • Documents monitoring activities in monitoring reports and follow-up letters. Communicates serious issues identified during on-site monitoring visits to the team in a timely manner
  • Reviews a percentage of monitoring visit reports as outlined in the monitoring plan and escalates any issues identified to the Clinical Trial Manager
  • Leads CRA calls
  • Serves as key contact person for site personnel to address operational issues
  • Serves as key contact person for site contract and budget negotiations
  • Presents and participates in Investigator Meetings and other study trainings as required
  • Tracks progress of enrollment, deviations and data entry for assigned sites and across the study; assess trends in effort to communicate issues/resolutions to the broader monitoring and study teams
  • Participates in the development and continuous improvement of SOPs and Clinical Operations systems
  • Basic Requirements:
  • Bachelor s Degree or related degree is required
  • At least 3 years of experience in clinical operations and previous monitoring experience
  • Working knowledge of GCP (Good Clinical Practices), ICH and relevant CFRs is required
  • Domestic and International travel as necessary (generally 30%, maybe greater depending on study needs)
  • Other Requirements:
  • Ability to work independently and manage multiple projects with minimal supervision
  • Strong communication skills, both written and oral
  • Demonstrated problem solving skills, a strong sense of urgency, keen attention to detail, and the ability to plan, organize and successfully execute in an environment under time and resource pressures
  • Willingness to act with integrity and to set personal standards of behavior that serve as a model for others within the organization
  • Enjoys working in a fast-paced, small-company environment.
  • Ability to work independently and manage multiple projects with minimal supervision
  • Strong communication skills, both written and oral
  • Demonstrated problem solving skills, a strong sense of urgency, keen attention to detail, and the ability to plan, organize and successfully execute in an environment under time and resource pressures
  • Willingness to act with integrity and to set personal standards of behavior that serve as a model for others within the organization
  • High level of organization, attention to detail, and accuracy
  • Proactively identifies issues and identifies solutions.
  • Acts with urgency and passion. Enjoys helping others.
  • Exceptional interpersonal skills, with a focus on rapport-building, listening and questioning skills.
  • Flexion Therapeutics - 28 days ago - save job - original job

    All Jobs in Boston, MA

    • Senior Clinical Research Associate

      Jacobio Pharmaceuticals Co., Ltd. Lexington, MA

      View Job
    • Associate Principal Consultant, Organizational Solutions

      Halloran Consulting Group Boston, MA

      View Job
    • Translational Biologist​

      Triplet Therapeutics Cambridge, MA

      View Job
    • Surgical Research Associate

      Toxikon Corporation Bedford, MA

      View Job
    • Associate Director, Data Management

      Premier Research Group Limited Boston, MA

      View Job
    • Clinical Trial Associate

      Summit Therapeutics Cambridge, MA

      View Job
    • Regulatory Affairs Associate

      Miltenyi Biotec, Inc. Cambridge, MA

      View Job
    • Qualitative Research Associate

      Boston Medical Center (BMC) Boston, MA

      View Job
    • Research Assistant - Division of Health and Environment

      Abt Associates Cambridge, MA

      View Job
    • Clinical Research Associate II

      Boston Biomedical Associates Marlborough, MA

      View Job
    • Associate Epidemiologist

      TriNetX Inc Cambridge, MA

      View Job

    Featured Articles

    Best SAP BW Online Training Conducted By Experts

    29 April 2016

    SAP BW stands for SAP Business Warehouse. It is BI, analytical, reporting, and data warehousing software. It is an embedded analytical engine. It is a valuable tool for developing data warehouses that accurately and effectively support critical business decision-making. It facilitates various featur

    read more..

    Chances of H1B Extension Rejection | Options after H1B Extension Denied

    05 October 2018

    If you’ve given a petition for H-1B transfer, it may be a cause of concern for you that it might be denied. The H1B non-immigrant work visa continues to attract the attention of many foreign workers who have a dream looking to have their career and life in the USA.

    read more..

    Oracle HRMS Online Training – Best in USA

    03 May 2016

    Oracle HRMS stands for Human Resource Management System. Its key processes include workforce administration, shared services, talent management, workflow analysis, HR intelligence, payroll and benefits, global HR, etc. It is known as “bets of the breed” solution because of its following salient

    read more..

    Things you need to know about CPT Visa Back-Up Plan

    05 July 2018

    F1 visa is a student’s visa for studying in USA and a good opportunity for gaining work experience in the form of CPT or OPT Jobs.  After you graduate in the United States, if the H1B draw is not drawn and the OPT is about to end, you may consider returning to school to extend F1 status. If H1B

    read more..

    Thanks For Your Feedback

    Attach A Resume First