Merck & Co., Inc., also known as Merck Sharp & Dohme LLC, is looking for an Intern Clinical Research Associate (CRA) to act as a primary site contact and manager throughout all phases of a clinical research study. With support, you will be responsible for building site relationships, performing monitoring activities, and ensuring data integrity and patient safety.

What You'll Do

Act as a primary site contact and site manager throughout all phases of a clinical study, taking responsibility for allocated sites.
Develop strong site relationships and ensure continuity through all phases of the trial.
Perform clinical study site management and monitoring activities in compliance with ICH-GCP, SOPs, local regulations, protocol, and monitoring plans.
Gain an in-depth understanding of the study protocol and related procedures.
Coordinate and manage tasks with other sponsor roles to achieve Site Ready status.
Participate and provide input on site selection and validation activities.
Perform both remote and on-site monitoring and oversight to ensure data is complete, accurate, and unbiased, and that subjects' rights and safety are protected.
Conduct site visits (validation, initiation, monitoring, close-out) and record clear, accurate reports in a timely manner.
Collect, review, and monitor required regulatory documentation for study start-up, maintenance, and close-out.
Communicate with Investigators and site staff on protocol conduct, recruitment, retention, deviations, documentation, audits, and site performance.
Identify, assess, and resolve site performance, quality, or compliance problems and escalate issues as appropriate.
Manage and maintain information and documentation in CTMS, eTMF, and other relevant systems.

What We're Looking For

Fluent in local languages and English (verbal and written).
Excellent communication skills, including the ability to understand technical information.
Good understanding of clinical research, phases of trials, current GCP/ICH guidelines, and country clinical research law.
Good understanding of Global and Country/Regional Clinical Research Guidelines and ability to work within them.
Hands-on knowledge of Good Documentation Practices.
Developing skills in Site Management, including managing site performance and patient recruitment.
Developing level of monitoring skill and independent professional judgment.
Good IT skills.
Effective time management, organizational and interpersonal skills, and conflict management.
Ability to work with experienced research professionals to develop skills across multiple protocols, sites, and therapy areas.
High sense of accountability and urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment, with support.
Ability to work effectively in a matrix, multicultural environment and establish culturally sensitive working relationships.
Demonstrates commitment to customer focus.