Senior CRA - CONTRACT
Initial 2 months contract
Home-based - UK
This position is responsible for performing of the following tasks and responsibilities, as well as any other tasks deemed appropriate by the Supervisor:
- Monitor activities at assigned clinical study sites to assure adherence to ICH GCPs, local regulatory requirements, Standard Operating Procedures (SOPs), Standard Guidelines (SGs), Instruction Manuals (IMs), study protocols and study-specific SGs/IMs, for multiple projects
- Conduct Pre-Study Site Visits (or calls), Study Initiation Visits, Routine Monitoring Visits and Site Close-out at assigned clinical study sites
- Ensure Serious Adverse Event (SAE) reporting according to project specifications
- Input and maintain study information in tracking systems
- Oversee study drug management at clinical study sites
- Perform Investigator Study File reconciliation
- Respond to requests from clinical study sites in a timely fashion
- Establish and maintain good rapport with clinical study sites
Education and Training:
- Bachelor's Degree in allied health fields such as Medical, Nursing, Pharmacy, or Health Science - or its international equivalent
Experience & Key Competencies:
- At least 2 years' experience as CRA in the field; or very strong experience as Research Nurse or Study Coordinator in oncology
- Oncology and local regulatory requirements knowledge would be a major asset Good knowledge of medical terminology and clinical monitoring process
- Strong ICH-GCPs knowledge
- Ability to travel up to 60% on average
- Ability to prioritize multiple tasks and achieve project timelines
- Excellent interpersonal, verbal and written communication skills and attention to details Ability to work in a multi-cultural environment
- Ability to manage sites independently
- Breast cancer disease experience in adventurous!
If you are interested in this exciting role, please send me your CV and I will be in touch with you.
- CRA (Clinical Research Ass)
- Senior CRA
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