Clinical Research Associate (CRA) (m/f/d)

Job content

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. 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. This is a full time position with flexible working arrangements.

As a Clinical Research Associate and under the supervision of the CRA Manager, you will ensure compliance of the studies conducted with ICH/GCP and country regulations, our Company’s policies and procedures, quality standards as well as adverse event reporting requirements internally and externally. You will act as the primary point of contact for the study sites and the site managers throughout all phases of the clinical research studies, taking overall responsibility of the allocated sites. On this rile you will actively develop and expand the territory for clinical research, finding and developing new sites and you will act as the subject matter expert for monitoring processes and systems.

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

• Bachelor’s or Master’s Degree in Biology or in subject with a natural science background.
• 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.
• Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.
• 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” showing the company’s commitment to our employees and the community around us.

The Switzerland Head Office of our company’s Swiss Subsidiary is based in Lucerne’s city centre. Located in the heart of the city, employees work collaboratively across many departments including commercial, market access, medical affairs, clinical research, regulatory affairs, and policy & communications.

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.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status

Regular

Relocation

No relocation

VISA Sponsorship

No

Travel Requirements

75%

Flexible Work Arrangements

Flex Time, Remote Work

Shift

Not Indicated

Valid Driving License

No

Hazardous Material(s)

N/A

Requisition IDR239021