• Full Time (Salaried)
  • , MA

Company:  Confidential

Job Title: Clinical Research Associate

Job Number: 34631

Location: , MA

Job Description

 ·Provide overall program support to the Clinical Operations team as well as liaise with other internal and external collaborators
· Draft and review study specific documents and plans such as informed consent forms, site training manuals, regulatory documents etc.
· Ensure study contact lists, metric trackers, checklists, and systems are up to date
· Assist with the development of the electronic case report form by providing review/input with clinical research, protocol, and site perspectives
· Participate in monitoring visits
· Plan site and CRA trainings

Responsibilities

· Acts as a liaison and resource for clinical trial sites
· Track clinical data entry expectations against monitoring activities and performance in preparation for data review meetings, data cuts, regulatory submissions, etc.
· Collaborate with vendors and CROs
· Manage the TMF by overseeing document collection and filing, ensuring compliance with the TMF plan, and performing periodic QCs
· Communicate with CROs and study sites to drive successful trial completion
· Assists in the development of timelines; tracks performance to forecasts
· Play a key role in the review of study specific data review
· Plan study related meetings and draft meeting agendas and minutes
· Effectively communicate trial details to ensure that all team members are kept informed
· Properly elevate particular situations with understanding of action items and their impact on the present & future
· Participate in the development and review of SOPs

Required Skills

 Bachelor’s degree in a relevant field· 5 plus years’ experience within a Clinical Operations team, 2+ years within monitoring
· Prior experience managing sites and being directly responsible for their performance at the Sponsor level
· Experience in diagnostic development trials a plus
· Solid knowledge of Good Clinical Practice (GCP) and the Code of Federal Regulations (CFR) is required
· Broad knowledge in clinical monitoring activities, site management and essential site documents
· Ability to work within a matrix team environment
· Strong communication skills, both written and verbal
· Ability to laugh at yourself
· Up to 50-65% travel required

 

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