Clinical Research Associate

vor 2 Wochen

Hannover, Deutschland Cardior Pharmaceuticals GmbH Vollzeit

Cardior Pharmaceuticals is a leading clinical-stage biopharmaceutical company pioneering the discovery and development of unique RNA-based therapeutics designed to prevent, repair and reverse diseases of the heart. Cardior’s therapeutic approach uses distinctive non-coding RNAs as an innovative platform for addressing the root causes of cardiac dysfunctions. The company aspires to bring transformative therapeutics and diagnostics to patients and thereby make a lasting impact on the treatment of cardiac diseases worldwide. Our lead compound CDR132L is currently in Phase 2.

We are seeking an experienced Clinical Research Associate to strengthen our clinical team in Hannover, Germany.

Novel, multi-causal curative treatment approach for card

**Clinical Research Associate**

**(CRA)**

**Employment type**
- Full time position (100%)
- Permanent position

**Major duties and responsibilities**:
Cardior is working with service providers (CROs) the Clinical Research Associate will support all activities regarding Sponsor oversight. The tasks will include routinely monitoring of the quality of clinical deliverables including co-monitoring visits and constant review of essential documentation and reports. You will work closely together with the Clinical Project Manager and Head of Clinical Operations, as well as with external experts to manage all aspects of clinical trials.

**Tasks and responsibilities**
- Co-monitoring of clinical trials in various indications in the cardiovascular area and overviewing the correct, complete, and timely collection of study data and documents.
- Timely production of high quality reports for co-monitoring visits.
- Training of external personnel in understanding and maintaining relevant study systems
- Participation in study team meetings and international investigator meetings
- Participation in the selection of study sites and assessment of recruitment potential
- Co-Initiation of study centers, support and guidance of external personnel
- Constant monitoring of site and vendor performance and quality, escalation of deficiencies to the Head of Clinical Operations
- Pro-active communication with the CROs
- Overseeing day to day activities for monitoring of a clinical study and sets priorities per site
- Reviewing trial documents and verifying they are accurate, complete, current, and include required updates
- Maintaining project tracking system
- SOP writing

**Key requirement, skills and capabilities**
- Degree in natural scientific / medical studies
- At least three years experience as a CRA in the conduct of clinical trials (ideally Phase II and III)
- Experience in risk-based quality management and remote monitoring
- Excellent ICH-GCP knowledge for the proper conduct of clinical trials
- Knowledge of the relevant laws (e.g. CTR) and regulatory requirements
- Good understanding of medical issues
- Understanding of different study and process requirements and the resulting prioritization of tasks
- Basic understanding of drug safety issues.
- Experience in monitoring electronic case report forms (web-based data capture) and advanced knowledge of standard software packages.
- Ability to think analytically and solution-oriented with independent, effective and structured organizational skills
- Ability to work in a team and be able to react quickly to changing requirements
- Willingness to undertake business trips with overnight stays away from home
- Excellent communication skills in German and English (both written and spoken)

**Additional desirable qualifications**
- Understand the specifics of acute cardiovascular studies
- Understand the challenge of complex study logistics
- Experience working in a matrix environment

**We offer**
- Excellent and flexible working conditions
- Varied tasks and responsibilities
- Working in a highly motivated and experienced team
- Competitive salaries
- Development perspective in a dynamic, aspiring company

**Contact**:
Your information and documents will be treated strictly confidential. According to article 6 DSGVO; also see - 32 BDSG by sending your documents you give your consent for storing and processing your data for the recruitment process. Cardior does not accept unsolicited resumes and inquiries from 3rd party recruitment agencies.

Art der Stelle: Vollzeit

Arbeitszeiten:

- Montag bis Freitag

Arbeitsort: Zum Teil im Homeoffice in 30419 Hannover

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