Senior Clinical Research Associate
New
P
Precision Medicine GroupClinical Trial Services
SerbiaFull-TimeSenior
Salary not disclosed
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Job Details
- Languages
- Serbian, English, Bulgarian
- Experience
- 3+ years of CRA experience
Requirements
- 3+ years of CRA experience within the CRO or pharmaceutical industry.
- 4-year college degree or equivalent experience.
- Fluency in Serbian, English, and Bulgarian languages.
- Ability to perform domestic travel, including overnight stays, up to 50-60%.
- Experience in biopharma or relevant therapeutic areas.
- Understanding of ICH-GCP and relevant regulatory standards.
- Graduate or postgraduate degree with a concentration in a scientific or healthcare discipline preferred.
- Experience with study start-up activities preferred.
- Experience with Phase I studies preferred.
- Financial management understanding preferred for senior level.
Responsibilities
- Monitor clinical study progress at investigative sites to ensure protocol adherence.
- Ensure studies are conducted, recorded, and reported per SOPs, ICH-GCP, and applicable regulations.
- Coordinate study setup activities including identifying investigators and assisting with regulatory submissions.
- Conduct pre-study and site initiation visits.
- Support Project Managers with large-scope clinical trials.
- Train and mentor junior staff members.
- Interact with clients, initiate payments, and participate in proposal development and presentations.
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