In-house Clinical Research Associate

TriWorth (RemoteBelgium, België) 9 uren geleden gepost

An In-house Clinical Research Associate will work closely with the Clinical Research Associates (CRAs) by providing centralized support to regional team members, assisting with the preparation, organization and follow-up of investigator and, site communications and clinical monitoring tracking both at a regional and global level.

  • Provide general support to the CRAs to manage investigational sites and ensure protocol and regulatory compliance

  • Assist investigational sites with study start-up activities to ensure study specific supplies are received

  • Contribute to the development of protocol-specific manuals, plans, and documents, as needed

  • Assist with the development of training content (monitoring visit training materials, monitoring visit reports, etc., as needed

  • To contact Clinical sites for specific requests

    • Enrollment updates, challenges with recruitment, supplies

    • Missing documentation

    • Data entry timelines, data query follow-up

    • Follow-up on action items

  • Track patient enrollment and assist with recruitment efforts by maintaining regular site contact

  • To assist CRAs with preparation for site visits (Communicating data entry, queries, tracking reports IRT/DM/Imaging/eCOA/Labs, TMF support, site performance, point of escalation, etc).

  • Assist CRAs with preparation for onsite and remote monitoring visits

  • Serve as primary CRA back-up

  • May assist with tracking project specific training for site personnel

  • Conduct Pre-Study visits and/or Close-out Visits as needed; Independently as approved

  • Co-monitor on assigned studies as needed

  • Assist with site quality management activities

  • Assist the CRA with Action Item and Protocol Deviation review and follow-up

  • Maintain FAQ list for assigned studies

  • Document site and sponsor contact and study interactions in a timely and professional manner

  • Assist with resolution of investigational site data queries

  • May provide study-specific direction, training, and mentoring to the monitoring team members

  • Other duties as assigned per Advanced Clinical needs

  • Minimum requirement of a Bachelor’s degree in biological sciences, healthcare, pharmacy, or nursing

  • Experience with Good Clinical Practices (ICH Guidelines; Good Quality Practices), 21 CFR Part 11 and Computer Security (Part 11, Electronic Records; Electronic Signatures-Scope and Application; 21 CFR 11 and Industry Guidances; Computerized Systems Used in Clinical Trials)


  • 2+ years In-House CRA/clinical trial support/project management support experience (both CRO and industry experience are acceptable)

  • Co-Monitoring experience

  • Experience conducting Pre-Study visits and/or Close-out Visits

  • Strong verbal and written communication skills. Excellent interpersonal and organizational skills with attention to detail

  • Strong computer proficiency in MS Office including Outlook, Word, Excel, and PowerPoint;

  • Ability to work well in a team environment but also independently without significant oversight.

In-house Clinical Research Associate

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