Clinical Research Associate II/III - US
RemoteUnited States
Job Summary
Conduct independent site visits for pre-study, initiation, interim monitoring, and closeout while managing assigned sites to ensure compliance and adequate enrollment. Independently perform CRF reviews, generate queries, and resolve issues against established guidelines. Identify escalating risks, prepare corrective and preventive action plans, and follow them to timely resolution. Negotiate study budgets with investigators and administer site payments per project instructions. Prepare documents for EC submissions and handle translation of study-related materials as instructed. This role supports Optimapharm's global CRO operations in Phase I–IV clinical studies, contributing to accelerated regulatory pathways and diverse patient recruitment.
Required Qualifications
- University degree, preferably in medical or life sciences; nursing education or other relevant healthcare college degree
- At least 2 years of independent clinical trial monitoring experience
- High level of knowledge of ICH GCP Guidelines, knowledge of regulatory requirements and a strong interest in clinical research
- Computer proficiency is mandatory
- Ability to read, analyze, and interpret common scientific and technical journals
- Excellent verbal and written communication skills
- Very good interpersonal and negotiation skills
- Ability to work independently, pro-active
- Affinity to work effectively and efficiently in a matrix environment
- A current, valid driver's license
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