Position: CRA
Location: China
FTE Available: Full
Available from: Immediate
Hourly charge rate: €83
Summary
- 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
Oncology
Cardiology
Diabetes
Respiratory
Neurology
Rheumatology
CNS
Ophthalmology
Endocrinology
Vaccines
Hepatology
Education
2017
Cranfield University
Msc in Clinical Research (Executive)
2008
University of Portsmouth
Bsc in Pharmacology
2001
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
Quintiles
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