We are looking for an international pharma company a temporary Clinical Research Associate who will join its Clinical Department in USA.
Do you have experience following study procedures according to study protocols, managing Investigational Product and trial documents and good communication skills is your strong point?
Then... THIS IS YOUR PROJECT!
Job Description:
The CRA will be in charge of different clinical trials, traveling around Spain and USA. This includes oversight of study procedures, ensure proper study compliance with regulations, improve patient recruitment and identify study issues, among others.
Responsibilities:
- Identify, select, and monitor performance of investigational sites for clinical studies.
- Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures.
- Write, contribute and review of clinical protocols, amendments, informed consent forms, study guides, case report forms, IMP release package and any other clinical research related documents.
- Track and report on progress of study including site activation, patient enrollment, monitoring visits.
- Act as Sponsor representative for study sites during study visits.
- Oversee proper training of staff members who are working on the study.
- Responsible for TMF maintenance.
- Contribution in all other study activities as required.
Requirements:
- Education: Degree in Health Sciences, preferably Pharmacy, but also Chemistry, Biology, Biochemistry, Veterinary or similar.
- Languages: Fluent Spanish and English, knowledge of other languages will be an asset.
- Experience (years/area): +2 years of experience as a Clinical Research Associate.
- Travels: Willingness to travel abroad (65%).
- Personal skills: Strong organizational and prioritization skills, effective written and verbal communication skills; ability to work under pressure in order to meet tight deadlines; client focused approach to work.
Benefits:
- 12 month contract by our client.
- Conditions according to experience.