Clinical Research Associate
Vor 7 Tagen
**Job Description**:
Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.
In support of our existing team we are currently looking for a **_Clinical Research Associate (CRA) M/F/d,_** home-based with a 2 years limited contract, in Germany.
**The main responsibilities**:
- Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
- Primary site contact and responsible for site management and monitoring activities throughout all study phases from validation to close-out.
- Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
- Gains an in-depth understanding of the study protocol and related procedures.
- Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
- Participates & provides inputs on site selection and validation activities.
- Conducts site visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
- Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head and CRD as needed.
- Supports and/or leads audit/inspection activities as needed.
- Performs co-monitoring visits where appropriate.
- Following the country strategy defined by CRD and/or CRA manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities.
**Your Qualifications**:
- Previous experience working as a Clinical Research Associate (CRA)
- Enjoys a high level of personal responsibility and readily supports site staff on-site including the required travels
- High affinity in examining medical data and source documents
- Detail-oriented and efficient in time management and ability to prioritize
- Strong communication and presentation skills
- Flexible and enjoys supporting sites on a path of constant change
- Excellent verbal and written communication skills in English and German
- Willingess to travel up to 75% within Germany
**Our Benefits**:
- Trustbased working hours (37.5 hours/week) and an attractive company pension scheme
- Competitive salary package: 13 monthly salaries + annual holiday pay + target bonus achievement
- 30 days holiday entitlement
- Company car
- Basic equipment for the home office
- Internal further training and promotion opportunities
- International cooperation
- On-the-job training
- Contribution of own ideas to the process design
- Corporate benefits
- Company health management system
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
**Who we are**
We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
**What we look for**
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
People with severe disabilities and their equivalents will be given preference if they are equally qualified.
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