Clinical Research Associate II/III - Poland

Optimapharm .

10d

About The Position

Optimapharm is seeking a Clinical Research Associate at CRA II or CRA III level, depending on experience, to join its team in Poland. The role is part of a defined career path: CRA I → CRA II → CRA III → Senior CRA. The associate will work on international clinical research projects as part of a multidisciplinary team, helping deliver clinical development activities for patients worldwide. The role involves independent clinical trial monitoring and management of assigned sites, including site visits, data review, risk escalation, CAPA follow-up, regulatory and ethics committee documentation, investigator budget negotiation, site contract support, and site payment administration. The position offers flexible work hours and a range of professional development and wellbeing offerings.

Requirements

University degree, preferably in medical or life sciences; nursing education or another relevant healthcare college degree is also accepted.
At least 2 years of independent clinical trial monitoring experience.
High level of knowledge of ICH GCP Guidelines and knowledge of regulatory requirements.
Fluent in the local language and English, both written and verbal.
Computer proficiency.
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 and proactively.
Ability to work effectively and efficiently in a matrix environment.
Current, valid driver’s license.

Nice To Haves

Experience in nephrology or urology clinical trials.
Experience in infectious diseases clinical trials.

Responsibilities

Perform routine site visits independently, including pre-study, initiation, interim monitoring, and closeout visits.
Manage assigned sites through regular contact with site personnel to ensure site compliance, adequate enrolment, and understanding of study requirements.
Independently perform CRF review and generate and resolve queries in line with established data review guidelines or applicable data management systems.
Identify and escalate potential risks and identify retraining opportunities for site personnel.
Prepare corrective and preventive action (CAPA) plans for issues identified during monitoring and proactively follow each CAPA through timely resolution.
Prepare documents required for ethics committee submissions and notifications, translate study-related documents where applicable, and perform other tasks as instructed by the supervisor.
Independently negotiate study budgets with potential investigators or institutions and assist with execution of site contracts where applicable.
Administer site payments in accordance with relevant project instructions.