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Job Description

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.

We are looking for a Clinical Research Associate who, with support from the Clinical Research Associate Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites. This is a field-based role.

Responsibilities:

• Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
• Performs clinical study site management and monitoring activities in compliance with International Conference on Harmonisation – Good Clinical Practice, Sponsor Standard Operating Procedures, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
• Gains an in-depth understanding of the study protocol and related procedures.
• Coordinates and manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
• Participates and provides inputs on site selection and validation activities.
• Performs remote and on-site monitoring and oversight activities using various tools to ensure:
  • Data generated at site are complete, accurate and unbiased.
  • Subjects’ right, safety and well-being are protected.
• Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit and non-visit contact reports appropriately in a timely manner.
• 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 and inspections and overall site performance.
• Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined Clinical Research Associate’s Escalation Pathway.
• Manages and maintains information and documentation to timelines.

Qualifications, Experience and Skills:

• A degree in science or science related degree.
• Clinical research experience. Related Clinical Research experience may include Clinical Trial Assistant, Study Coordinator or similar.
• Fluent in English and excellent communication skills, including the ability to understand technical information. Developing the ability to present technical information with support.
• Good understanding and working knowledge of clinical research, phases of clinical trials, current International Conference on Harmonisation – Good Clinical Practice and country clinical research law and guidelines.
• Good understanding of Global, Country and Regional Clinical Research Guidelines and ability to work within these guidelines.
• Hands on knowledge of Good Documentation Practices
• Developing skills in Site Management including management of site performance and patient recruitment
• Developing level of monitoring skill and independent professional judgment.
• Good IT skills and ability to adapt to new IT applications on various devices.
• Effective time management, organizational and interpersonal skills.
• Able to work with other experienced research professions to develop skills across multiple protocols, sites and therapy areas.
• Sense of accountability and urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment, with support from Line Manager
• Works effectively in a matrix multicultural environment. Ability to establish and maintain working relationships.
• Excellent Customer focus and engagement.
• Ability to travel domestically and internationally approximately around 65%-75% of working time. Expected travelling is around 2-3 days per week.
• Current driver’s license.

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.

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:R241940