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

RxREVU, Inc.; Rostock; Vor Ort; EUR 52.000 - 76.000; Vollzeit

Benefits dieser Stelle

Sign-on bonus included

Zusammenfassung

Optimapharm invites applications for a Clinical Research Associate role in Germany. You will conduct site visits, ensure regulatory and data quality, and collaborate with site personnel to maintain study timelines.

This position emphasizes independent work within a global CRO setting, requiring strong communication and negotiation skills. The successful candidate will have 2-3 years of independent monitoring experience, a healthcare-focused degree, fluency in English and the local language, and

Qualifikationen

• 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 knowledge of ICH GCP guidelines and regulatory requirements; strong interest in clinical research.
• Fluent in local language and English (spoken & written).
• 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, pro-active.
• Ability to work in a matrix environment.
• A current, valid driver's license.

Aufgaben

• Perform routine site visits independently (pre-study, initiation, interim monitoring, closeout).
• Manage sites with regular contact to ensure compliance and enrolment targets.
• Independently perform CRF review; generate queries and resolve per guidelines.
• Identify and escalate potential risks; identify retraining opportunities for staff.
• Prepare CAPA plans for issues and follow them through to resolution.
• Prepare EC submission documents and translations; other supervisor-directed tasks.
• Negotiate study budgets and assist with site contracts as applicable.
• Administer site payments according to project instructions.

Kenntnisse

CRA monitoring experience

Communication skills

ICH GCP knowledge

Independent work

Interpersonal & negotiation skills

Ausbildung

University degree in medical or life sciences

Nursing education or healthcare degree

Jobbeschreibung

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 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.