Clinical Research Associate

vor 5 Monaten

Luzern, Schweiz MSD Vollzeit

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. We offer long-term career opportunities in a company which values innovation, efficiency, diversity and respect. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork.

For our Swiss subsidiary in Global Human Health based in Lucerne, we are currently looking for a Clinical Research Associate (M/F/d) who will be responsible for the performance and compliance of the assigned protocols and sites in Switzerland (full-time, indefinite, home-based).

**THE PRIMARY ACTIVITIES INCLUDE BUT ARE NOT LIMITED TO**:

- Develop strong site relationships and ensure continuity of site relationships through all phases of the trial
- Perform clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents
- Coordinate & manage various tasks in collaboration with other sponsor roles to achieve Site Readiness. Participate & provide input on site selection and validation activities
- Perform remote and on-site monitoring & oversight activities to ensure that the data generated at site is complete, accurate and unbiased; and to ensure the Subjects’ rights, safety and well-being are protected
- Conduct site visits (validation visits, initiation visits, monitoring visits, close-out visits, etc) and documentation of clear, comprehensive and accurate visit & non-visit contact reports appropriately and in a timely manner.
- Collect, review and monitor the required regulatory documentation for study start-up, study maintenance and study close-out
- Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance
- Identify, assess and resolve site problems (performance, quality or compliance) and escalate per defined CRA Escalation Pathway as appropriate in collaboration with the CRA manager, CRM, and RCPM
- Contribute to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/required
- Support and/or lead audit/inspection activities as needed

**QUALIFICATIONS**:

- Initial direct site management (monitoring) experience in a (bio)pharmaceutical company or CRO
- Ability to travel domestically approximately up to 75% of working time (2-3 days/week)
- Knowledge of Site Management including management of site performance and patient recruitment
- Good understanding of clinical research, phases of clinical trials, current GCP/ICH & swiss clinical research laws and guidelines
- Good knowledge of oncology studies
- Hands-on knowledge of Good Documentation Practices
- Ability to understand and analyze data/metrics and act appropriately
- Fluent German and English knowledge, both written and spoken. French or Italian knowledge is advantageous
- Strong communication skills and the ability to understand and present technical information effectively
- Strong customer and patient focus; demonstrated ability to translate science into an easy to communicate language
- Effective time management skills, organizational and interpersonal skills, conflict management and problem solving skills
- Ability to work highly independently across multiple protocols, sites and therapy areas

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.

**THE COMPANY**

Our company has had a presence in Switzerland since 1963. With a regional office and manufacturing/packaging facility, Lucerne is considered the center of operations. Approximately 1,000 people work collaboratively at the four Lucerne locations (Tribschenstrasse, Citybay, Schachen and Kriens). A fifth location has been recently established in Zurich, aimed at accelerating the development and commercialization of many of our company’s medicines and vaccines, which supports our mission to save and improve lives around the world. The new location has a target date of 2021 for operational readiness.

We are proud to be certified as a “Top Employer Switzerland” and “Top Employer Europe”

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