Job Description

The role is accountable for performance and compliance for assigned protocols and sites in a country. Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.

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.

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 CRAManager, 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 Practise & country clinical research law & guidelines
Min. 1 year of independent 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

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.

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.

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Remote

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID: R291696

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Clinical Research Associate