Venenatis Justo

Web Developer

Position: CRA

Location: China

FTE Available: Full

Available from: Immediate

Hourly charge rate: €83


  • 6 Years’ experience in clinical research
  • Experienced in working with IMP, biologic and medical device products from phases I-IV
  • Ethics and regulatory submissions as lead in the U.K.
  • Extensive experience in study start up activities including site feasibility assessments, contract negotiation, ethics and regulatory submissions, site initiation and TMF / ISF set up
  • Thorough experience in close out activities – site closure and study archival
  • Working knowledge of ICH/GCP, ISO 14155, EU and Medical Device Directives, ABPI Code of Practise and prior experience under GMP and Annexe 13
  • Audit experienced by Sponsor and internal Quality Assurance as well as regulatory inspected by both MHRA and FDA in clinical settings
  • In depth knowledge of clinical software packages including EDC (MACRO, Medidata RAVE, and InForm) and CTMS (Siebel 7 and generic software
  • Experience in CRO, pharmaceutical and biotechnology settings in both office and field based roles

Therapeutic Areas














Cranfield University

Msc in Clinical Research (Executive)


University of Portsmouth

Bsc in Pharmacology


Institute of Clinical Research

Institute of Clinical Research Examination

Employment History

Nov 16, 2018 - Present

InVentiv Health

Freelance CRA

Perform either on-site or remote site visits and monitoring activities in accordance with protocol, GCP/ICH Guidelines, and other applicable regulatory requirements

Mentor CRAs on monitoring, internal procedures, and query resolution

Maintain working knowledge of GCP/ICH Guidelines as well as all applicable regulations

Apr 2, 2019 - May 30, 2020


Freelance CRA

Perform site selection (if applicable), initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.

Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.

Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation

Apr 14, 2021 - May 13, 2021

Gaea Clinical

Freelance CRA

Managing EC and R&D applications and approvals in cooperation with the Gaea contracts Attorney and other Gaea staffing

Jan 1, 2016 - Jan 30, 2016

Glenmark Pharmaceuticals

Freelance CRA