Sr. Clinical Research Associate at MSD

Job Description

We are a research-driven biopharmaceutical company, and 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. As a Senior Clinical Research Associate, you will be accountable for performance and compliance for assigned protocols and sites in a country. You will act as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.

Job Description:

• Performs clinical study site management/monitoring activities in compliance with Good Clinical Practice and associated documents & regulations,

• Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out,

• Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance,

• Contributes to Clinical Research Associate (CRA) team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/required,

• Supports and/or leads audit/inspection activities as needed,

• Following the country strategy defined by Clinical Research Director and CRA Manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities.

Qualifications:

• B.A./B.S. with strong emphasis in Science and/or Biology is preferred,

• Fluent in Local Languages and English (verbal and written) and excellent communication skills,

• Good understanding and working knowledge of clinical research, phases of clinical trials, current Good Clinical Practice & country clinical research law & guidelines,

• Min. 4 years of direct site management (monitoring) experience in a bio/pharma/ Clinical Research Organization (CRO),

• Ability to travel domestically and internationally approximately 65%-75% of working time. Expected travelling ~2-3 days/week,

• Current driver’s license.

Current Employees apply HERE

Current Contingent Workers apply HERE

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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. 

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Relocation:

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