Requisition ID: CLI008101
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck's Animal Health (MAH) Division works to improve the health of animals around the world through collaborative partnerships and a deep sense of responsibility towards our customers, consumers, animals, society, and planet. This team of energetic, independent thinkers offers one of the industry's most innovative portfolios of products, services, and technologies that serve to prevent, treat, and control diseases across all major farm and companion animal species both domestically and internationally.
The primary function of the Clinical Research Associate (CRA) position is to monitor clinical laboratory and field studies that will support the regulatory approval of new companion animal and livestock products. These studies must be conducted in compliance with the requirements of Good Clinical Practice (GCP).
The CRA acts primarily as the study monitor and is the primary contact with study sites and investigators. The CRA, in collaboration with the Clinical Research Manager (CRM), designs, conducts and reports clinical studies according to GCP.
Specifically, the CRA has the following tasks and responsibilities:
• Assist the CSTL with the selection of study sites, Investigators and laboratories.
• Train the Investigator(s) and other study participants, as appropriate, for the study protocol and Good Clinical Practice.
• Conduct monitoring visits and maintain communication with investigators and other study personnel.
• Prepare study documentation such as notebooks and Case Report Forms, in collaboration with Data Manager.
• Organize the shipment and submission of study materials and samples as appropriate.
• Apply for the necessary local study permits and licenses in close collaboration with the CRM.
• Maintain an accurate and complete log of all contacts with the investigator and other study participants and ensure that deviations from the protocol are documented.
• Ensure that adverse events are documented and reported according to the applicable procedures and time lines.
• Review the raw data and ensure that illegible or missing data are explained and/or corrected.
• Organize translation of study documents as appropriate.
• Enter data into an electronic data set, as required, and/or check correct data entry.
• Ensure that data queries are answered and documented adequately.
• Check the correct storage, dispensing and disposal of the study products and its documentation.
• Maintain inventory of (I)VP, CP and test materials, as appropriate.
• Participate in the preparation of the Study Documentation File (SDF).
In addition, the CRA:
• Performs quality control inspections of study protocol, study documentation and reports as appropriate.
• Performs User Acceptance Tests of electronic CRFs.
• A more experienced CRA may act as Clinical Study Team Leader (CSTL) for certain small scale studies or studies with a standard design. This includes the responsibility for design, budget, protocol and report of the study.
Education Minimum Requirement:
• A Bachelor degree or equivalent in a relevant biological field
Required Experience and Skills**:
- A minimum of three (3) years of experience in clinical research or equivalent role.
- Experience in a clinical study related role.
- Good written and oral command of English language and if possible of German and/or French.
- Good communication skills.
- A strong ability in scientific writing.
- Proficient in MS Office applications and in EDC.
Preferred Experience and Skills:
• Additional animal science related degree or experience.
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we're counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we're inventing for life.
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Job: Clinical Research Monitor
Employee Status: Regular
Travel: Yes, 50 % of the Time
Number of Openings: 1
Shift (if applicable): N/A
Company Trade Name: Merck
Nearest Major Market: New Jersey