Clinical Research Associate - Germany (with sign-on bonus)

Optimapharm d.o.o.; Rostock; Sur place; EUR 45 000 - 60 000; Plein temps

Avantages offerts par ce poste

Sign-on bonus included

Performance bonus

Referral bonus

Flexible work hours

Shopping discounts

Employee engagement programs

Well-being initiatives

Training and development program

Résumé du poste

Optimapharm is seeking a CRA to monitor sites across Germany and contribute to high-quality clinical trials. The role supports pre-study, initiation, interim monitoring and closeout visits, ensuring site compliance and proper enrolment.

You will review CRFs, identify risks, and implement CAPA plans with supervisory guidance. You will negotiate budgets, coordinate EC submissions, and manage site payments, working within a dynamic, matrixed global CRO environment.

Qualifications

• University degree 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, regulatory requirements
• Fluent in local language and English, both written and verbal
• Computer proficiency is mandatory
• Ability to read, analyze, and interpret scientific/technical journals
• Excellent verbal and written communication skills
• Very good interpersonal and negotiation skills
• Ability to work independently, pro-active
• Affinity to work effectively in a matrix environment
• A current, valid driver’s license

Responsabilités

• 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 data review guidelines or data management systems
• Identify and escalate potential risks and retraining opportunities for site personnel
• Prepare corrective and preventive (CAPA) plans for issues identified during monitoring activities and follow up until timely resolution
• Prepare documents for EC submissions and notifications, translate study-related documents (where applicable)
• Independently negotiate study budgets with investigators/institutions and assist with site contracts
• Administration of site payments in accordance with project instructions

Connaissances

Fluent English

Verbal and written communication

Interpersonal & negotiation

Independent work

Formation

University degree in medical or life sciences

Description du poste

Location: Preferably in the northern part of Germany

Who we are?

Optimapharm is a mid-sized, global Contract Research Organisation (CRO) turning science into hope through agile, patient-focused clinical development. We specialise in Phase I-IV clinical studies, delivering Full-Service and Functional Service Provision (FSP) solutions that help sponsors move faster and execute with confidence. With operations in 40+ countries and 2x the patient reach of the average mid-sized CRO, we enable accelerated regulatory pathways, faster study start-up, and access to diverse patient populations worldwide. At Optimapharm, you'll contribute to meaningful clinical research while growing your career in a dynamic, people-focused, global environment.

We're looking for a new CRA - whether you're building your expertise as a CRA II or ready to step into a higher CRA role, this is your chance to shape the future of clinical research - delivering excellence for our sponsors and meaningful impact for patients and families worldwide. This role sits within a defined CRA career path: CRA I CRA II CRA III Senior CRA.

Incentive: Sign-on bonus included

What do we offer?

• Working in a successful company that's growing and developing every day
• Being part of a clinical research team that transforms science into hope for patients
• International projects and professional growth
• Working with a highly experienced team of clinical research professionals
• Performance bonus
• Referral bonus
• Flexible work hours
• Shopping discounts
• Employee engagement programs
• Well-being initiatives
• Training and development program

Who are we looking for?

Qualifications and Experience

• 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

Your 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 up 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

By joining our fast-growing and prosperous team, you will have an excellent opportunity for further personal growth and career development.

Compensation is competitive and final offers will reflect each candidate's experience, skills, and qualifications.