Get Clinical Research JobsGet Clinical Research Jobs

Clinical Trial Associate


  • Beacon Hill Staffing Group - Pharma
  • 05/20/20
  • Boston, MA
  • 02108
  • 50 / Hourly
  • Contractor
his role will focus on providing clinical study support during start-up, maintenance and close out. Additionally, s/he will help to ensure clinical operational deliverables and timelines are met across the development program(s). Reporting to the Clinical Trial Manager, this individual will be responsible for overall operational management of multiple clinical development studies, including:

Key Responsibilities

Support interdisciplinary activities, participate in Clinical Trial Working group(s) meetings in order to meet goals and establish timelines

Provide support in managing Contract Research Organizations (CROs) and other external vendors to ensure successful clinical trial implementation

Liaise with clinical sites as appropriate to ensure optimal sponsor-site relationships

Assist in preparation of informed consent forms, regulatory packets, clinical study reports and other clinical documents as necessary

Assist in the creation of study materials, including but not limited to documents, presentations, reports and study plans

Conduct initial review and tracking of invoices and study payments

Establish and maintain tracking tools for assigned trials

Generate, review and approve Trial Master File (TMF) document workflows and perform TMF review

Participate in team meetings and assist in the preparation of agendas, minutes and tracking of action items

Perform administrative tasks to support Clinical Operations and team members as needed

Provide support to all aspects of study progress (from planning to close-out), to assure adherence to intended timelines and achievement of study goals, while ensuring quality in accordance with FDA, EMEA, GCP, and ICH guidelines.



Minimum Requirements

Bachelors degree (scientific or healthcare discipline preferred) plus at least 1-4 years in clinical and drug development (more experienced candidates will be considered for the Sr. title)

Experience in hematology/oncology preferred

Proven experience in the oversight of the operational aspects of all stages of clinical studies, preferably in a global environment

Knowledge of ICH GCP and knowledge of Medical Terminology strongly preferred

Ability to organize and manage multiple priorities required

Strong oral and written communication skills required

Proficiency in Microsoft Word, Excel and PowerPoint

Ability to multitask with significant attention to detail

Ability to work independently and in a matrix team environment



Competencies

Applies creative, original ideas to accomplish work; identifies more than one way to solve problems.

Builds networks internally and externally to stay relevant on new discoveries, trends and uses them to make meaningful connections to drive innovation and learning.

Grows knowledge and capability in self and others by teaching, coaching and mentoring.

Work in and with teams to achieve outcomes that individuals would not have been able to achieve alone.

Maintains line of sight to team and company priorities; understands and values all areas of business. Creates connections beyond own role/function.

Possesses technical or professional expertise and is able to apply it to create value/impact.

Acts with a sense of urgency; with the end result in mind and is able to follow through to deliver exceptional results.

Taking an approach to continuous improvement; anticipates and addresses capability gaps to prepare for future challenges.

Takes accountability as individuals and as teams; acts like an owner.


Browse other Clinical Research Jobs in Massachusetts

  1. Senior Medical Science Liaison - Oncology

    Boston, MA
    Senior Medical Science Liaison - Oncology US-ME- Job ID: 2020-1623 Type: Oncology # of Openings: 1 Category: Medical Science Lia...
  2. Medical Science Liaison - Oncology

    Boston, MA
    Medical Science Liaison - Oncology US-ME- Job ID: 2020-1620 Type: Oncology # of Openings: 1 Category: Medical Science Liaison BE...
  3. Clinical Scientist, Senior

    Boston, MA
    The Clinical Scientist will work with the Medical Lead and provide scientific, clinical, and operational input to early and late s...
  4. Senior Clinical Pharmacologist

    Boston, MA
    Sr Clinical Pharmacologist manages scientific and operational aspects at a study level and assists development at a program level....
  5. Principal Medical Writing Scientist

    Boston, MA
    The Vertex Medical Writing department is a collaborative team responsible for supporting development programs throughout the produ...
  6. Sr. Medical Writing Scientist

    Boston, MA
    The Senior Medical Writing Scientist is responsible for preparing routine clinical study documents and sections of regulatory subm...
  7. Principal Medical Writing Scientist

    Boston, MA
    Job Description: The Vertex Medical Writing department is a collaborative team responsible for supporting development programs th...
  8. Principal Medical Writing Scientist

    Boston, MA
    The Medical Writing department is a collaborative team responsible for supporting development programs throughout the product life...
  9. Sr. Medical Writing Scientist

    Boston, MA
    Job Description: The Senior Medical Writing Scientist is responsible for preparing routine clinical study documents and sections...
  10. Oncology Medical Science Liaison

    Boston, MA
    Overview Researched and relatable, science-driven and social, youre an extroverted expert. If theres one thing your preparation i...