Job Description

Join Our Team as a Clinical Research Associate (CRA)!

The Clinical Research Associate (CRA) plays a critical role to ensure performance and compliance for our company Protocols. Under the guidance of the Country Research Manager(CRM) / Line Manager (LM), you will be responsible for ensures country regulations, our company policies and protocol procedures fulfill in timely manner throughout all phases of clinical research study.

Your contributions will be key in meeting study enrollment commitments and improving cycle times, including developing a strong collaboration with the Clinical Operations Manager (COM), Therapeutic Area Lead (TAH), Clinical Research Manager (CRM). In addition, you will partner with regulatory, supplies, finance and site staff efficiently managing.

Responsibilities include, but are not limited to:

• Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
• Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan, and associated documents.
• Gains an in-depth understanding of the study protocol and related procedures.
• Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive, and accurate visit & non-visit contact reports appropriately in a timely manner.
• 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.

Extent of Travel

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

CORE Competency Expectations:

• Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.
• Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
• Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
• Hands on knowledge of Good Documentation Practices
• Proven Skills in Site Management including management of site performance and patient recruitment.
• Demonstrated high level of monitoring skill with independent professional judgment.
• 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.
• Ability to understand and analyses data/metrics and act appropriately.
• Performs root cause analysis and implements preventive and corrective action.

Behavioral Competency Expectations:

• Effective time management, organizational and interpersonal skills, conflict management, problem solving skills
• Able to work highly independently across multiple protocols, sites and therapy areas.
• High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment.
• Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
• Demonstrates commitment to customer focus
• Works with high quality and compliance mind-set
• Positive mindset, growth mindset, capable of working independently and being self-driven

Experience Requirements:

• Min. 2 years of direct site management (monitoring) experience in a bio/pharma/CRO.

Educational Requirements:

• Preferred Scientific / healthcare discipline together with at least 5 years of relevant experience in the healthcare field.

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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

05/31/2025

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