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

Optimapharm d.o.o.; Lübeck; On-site; EUR 46,000 - 65,000; Full time

Benefits offered by this job

Sign-on bonus included

Performance bonus

Referral bonus

Flexible work hours

International projects

Training and development program

Well-being initiatives

Employee engagement programs

Shopping discounts

Job summary

Optimapharm d.o.o. is seeking a Clinical Research Associate (CRA) to monitor sites across Germany. You will perform routine site visits, manage site compliance, and ensure enrolment targets while upholding ICH GCP guidelines and regulatory requirements.

The role offers a defined CRA career path (CRA I–Senior CRA), a sign-on bonus, performance and referral bonuses, flexible hours, and opportunities to work with an experienced global team on international projects.

Qualifications

• University degree in medical or life sciences; nursing education or other healthcare degree.
• 2-3 years of independent clinical trial monitoring in a CRO/pharma.
• Strong knowledge of ICH GCP guidelines and regulatory requirements.
• Fluent in local language and English, both written and verbal.
• Proficient computer skills and ability to read and interpret scientific literature.
• Excellent verbal and written communication; strong interpersonal and negotiation skills.
• Ability to work independently in a matrix environment; valid driver’s license.

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 compliance and enrolment.
• Independently perform CRF review, query generation, and resolution.
• Identify risks and retraining opportunities for site personnel.
• Prepare CAPA plans and follow up until resolution.
• Prepare documents for EC submissions and translate study documents when applicable.
• Negotiate study budgets with investigators and assist with site contracts.
• Administer site payments according to project instructions.

Skills

English fluency

Local language fluency

Verbal and written communication

Independent working

Matrix environment

Computer proficiency

Education

Life sciences degree

Nursing or healthcare degree

Tools

ICH GCP knowledge

Regulatory requirements knowledge

Job description

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.