• , US

Company:  Confidential

Job Title: Clinical Research Associate

Job Number: 76825

Location: , US

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

Application Deadline: 2024-06-03

 

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