Job Description

Join Our Team as a Clinical Research Associate!

Are you passionate about advancing clinical research and making a difference in healthcare? We are looking for a dedicated Clinical Research Associate (CRA) to join our team. In this role, you will be responsible for performance and compliance across assigned protocols and sites within the country, ensuring that all study conduct aligns with International Council for Harmonisation/Good Clinical Practice (ICH/GCP) guidelines as well as our organizational policies.

Key Responsibilities

• Serve as the primary site contact and manager throughout all phases of clinical research studies.
• Develop and maintain strong relationships with study sites to ensure continuity and success throughout the trial phases.
• Conduct site management and monitoring activities in compliance with ICH/GCP, Sponsor Standard Operating Procedures (SOPs), local laws, and regulations.
• Gain comprehensive knowledge of study protocols and related procedures.
• Collaborate with various sponsor roles to coordinate and manage tasks for "Site Ready" status.
• Participate in site selection and validation activities.
• Perform remote and on-site monitoring to ensure data integrity and protection of subjects’ rights.
• Conduct site visits, including initiation, monitoring, and close-out visits.
• Collect and manage required regulatory documentation for studies.
• Communicate effectively with investigators and site staff concerning protocol conduct and overall site performance.
• Identify, assess, and resolve site performance or compliance issues in collaboration with stakeholders.
• Work with internal and external teams to support assigned sites.
• Maintain information in Clinical Trial Management Systems (CTMS), electronic Trial Master Files (eTMF), and other systems as required.
• Act as a Subject Matter Expert (SME) and mentor to colleagues.
• Support audit/inspection activities as needed.
• Identify and develop new potential sites.

Main Requirements

Education:

• Associate's degree, certificate, or equivalent in a scientific or healthcare discipline; or
• Bachelor’s degree (or higher) in a scientific or healthcare disciplin.

Experience:

• If you hold an Associate's degree, you must have a minimum of 5 years of relevant healthcare experience, including at least 2 years in direct site management (monitoring) within a biotechnology, pharmaceutical company, or Contract Research Organization (CRO).
• If you hold a Bachelor’s degree (or higher), you must have at least 2 years of direct site management (monitoring) experience within a biotechnology, pharmaceutical company, or CRO.

Languages:

• Fluent in Spanish and English (verbal and written).

Skills:

• Good understanding of clinical research and GCP/ICH guidelines.
• Proven site management and patient recruitment skills.
• Strong monitoring skills with independent professional judgment.
• Proficient in IT applications (MS Office and clinical IT tools).
• Ability to understand and analyze data and metrics.
• Effective time management and organizational skills.
• Travel: Ability to travel domestically and internationally approximately 65%-75% of working time (expected travel 2-3 days/week).
• Driver’s License: Current driver’s license preferred.

Are you ready to take your career to the next level and make a significant impact in clinical research? Apply now and be a part of our mission to enhance healthcare!

ClinicalTrialsPR

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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

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Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

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Job Posting End Date:

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Requisition ID:R342257