Clinical Research Associate II/III - Germany

Optimapharm .

23d•Remote

About The Position

Optimapharm is a mid-sized, global Contract Research Organisation (CRO) specializing in Phase I–IV clinical studies, delivering Full-Service and Functional Service Provision (FSP) solutions. With operations in 40+ countries, they enable accelerated regulatory pathways, faster study start-up, and access to diverse patient populations worldwide. This role is for a Clinical Research Associate (CRA II - III, depending on experience) within a defined CRA career path (CRA I → CRA II → CRA III → Senior CRA). The position offers the opportunity to contribute to meaningful clinical research and grow a career in a dynamic, people-focused, global environment.

Requirements

University degree, preferably in medical or life sciences; nursing education or other relevant healthcare college degree
At least 2 - 3 years of independent clinical trial monitoring in a CRO/pharma
High level of knowledge of ICH GCP Guidelines, knowledge of regulatory requirements and a strong interest in clinical research
Fluent in local language and English, both written and verbal
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

Responsibilities

Perform routine site visits independently, including pre-study, initiation, interim monitoring and closeout visits
Manage assigned sites by regular contact with site personnel to ensure site compliance, adequate enrolment and understanding of study requirements
Independently perform CRF review; query generation and resolution against established data review guidelines or data management systems as applicable
Identifying and escalating potential risks and identifying retraining opportunities for site personnel
Preparation of corrective and preventive (CAPA) plans for issues identified during monitoring activities and pro-active follow of each, individual CAPA until timely resolution
Preparation of documents required for EC submissions and notifications, translation of study-related documents (where applicable), and other tasks as instructed by the supervisor
Independently negotiate study budgets with potential investigators/institutions and assist with the execution of site contracts as applicable
Administration of site payments in accordance with relevant project instructions