Clinical Research Associate

Meet Life Sciences

Indiana

On-site

USD 60,000 - 80,000

Full time

14 days+

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Benefits offered by this job

Medical insurance

Vision insurance

401(k)

Job summary

A leading company in pharmaceutical manufacturing is seeking a detail-oriented Clinical Research Associate to support clinical trials. The role involves ensuring compliance with regulatory standards, conducting site visits, and collaborating with various teams to maintain data integrity. Ideal candidates will have a background in life sciences and experience in clinical operations.

Qualifications

Minimum of 2 years of experience in clinical trial monitoring or clinical operations.
Strong understanding of ICH-GCP guidelines and regulatory requirements.

Responsibilities

Review clinical study protocols and reports.
Conduct site qualification and monitoring visits.
Collaborate with cross-functional teams for data collection.

Skills

Communication

Organizational Skills

Problem-Solving

Education

Bachelor’s degree in a life science or healthcare-related field

Advanced degree preferred

Job description

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We are seeking a detail-oriented and proactive Clinical Research Associate to support the planning, execution, and monitoring of clinical trials. This role ensures compliance with regulatory requirements and company standards while contributing to high-quality data collection and study integrity.

Key Responsibilities:

Review and provide input on clinical study protocols, informed consent forms, and clinical study reports.
Conduct site qualification, initiation, monitoring, and close-out visits in compliance with GCP, regulatory requirements, and SOPs.
Collaborate with cross-functional teams (Data Management, Regulatory Affairs, and Clinical Operations) to develop data collection tools and ensure accurate data capture.
Track and manage study documentation, including regulatory binders, site files, and ethics submissions.
Ensure timely collection and review of essential documents and compliance with regulatory timelines.
Identify and resolve site issues and protocol deviations, escalating as necessary.
Assist in organizing investigator meetings and contribute to training materials and site support documentation.
Maintain up-to-date knowledge of therapeutic areas, regulatory guidelines, and clinical trial processes.

Qualifications:

Bachelor’s degree in a life science or healthcare-related field; advanced degree preferred.
Minimum of 2 years of experience in clinical trial monitoring or clinical operations.
Strong understanding of ICH-GCP guidelines and regulatory requirements.
Excellent communication, organizational, and problem-solving skills.
Ability to travel as needed to support clinical trial sites

Seniority level