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

RxREVU, Inc.; Bremen; Vor Ort; EUR 60.000 - 80.000; Vollzeit

Benefits dieser Stelle

Sign-on bonus

Performance bonus

Referral bonus

Flexible work hours

Well-being initiatives

Training and development program

Employee discounts

Zusammenfassung

Optimapharm is seeking a new CRA to advance its world-class clinical research efforts. Whether advancing from a CRA II role or stepping into higher CRA responsibilities, you will contribute to international projects and work with an experienced team of clinical research professionals.

The role emphasizes site monitoring, data reviews, and budget negotiations, with a focus on quality and compliance in a matrix environment. A valid driver's license is required.

Qualifikationen

• University degree, preferably in medical or life sciences; nursing education or other relevant healthcare 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, and interest in clinical research.
• Fluent in local language and English, both written and verbal.
• Computer proficiency is mandatory.
• Ability to read, analyze, and interpret scientific and technical journals.
• Excellent verbal and written communication skills.
• Very good interpersonal and negotiation skills.
• Ability to work independently and proactively.
• Affinity to work in a matrix environment.
• A current, valid driver’s license.

Aufgaben

• 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 and adequate enrolment.
• Independently perform CRF review; query generation and resolution per data review guidelines.
• Identify and escalate potential risks and retraining opportunities for site personnel.
• Prepare CAPA plans for issues identified during monitoring and follow until resolution.
• Prepare documents for EC submissions and translations where applicable, and other supervisor-directed tasks.
• Negotiate study budgets with investigators/institutions and assist with site contracts.
• Administer site payments per project instructions.
• Growth and development opportunities within a fast-growing team.

Kenntnisse

ICH GCP Knowledge

Fluent in English

Fluent in local language

Independent monitoring

Driver's license

Analytical reading of journals

Communication skills

Pro-active working style

Matrix environment experience

Ausbildung

University degree in medical or life sciences

Nursing education or healthcare degree

Jobbeschreibung

Location: Preferably in the northern part of Germany

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.

Who we are?

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

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 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.

Disclaimer: Unsolicited CVs sent to Optimapharm (Talent Acquisition Team, Hiring Managers or any other OPT employee) by recruitment agencies will not be considered for this role. Optimapharm follows a direct sourcing strategy and collaborates exclusively with selected recruitment partners when external support is required.