Clinical Site Manager

Lumicity; United States; On-site; USD 85,000 - 100,000; Full time

Job summary

An established industry player is seeking a Clinical Trial Monitor to oversee and ensure the compliance of clinical trial sites. In this dynamic role, you will coordinate site activities, manage documentation, and maintain strong relationships with investigators. Your expertise will help ensure adherence to regulatory requirements and Good Clinical Practices. This full-time position offers a competitive salary and benefits, including medical and vision insurance. If you are passionate about advancing clinical research and thrive in a fast-paced environment, this opportunity is perfect for you.

Benefits

Medical Insurance

401(k)

Vision Insurance

Qualifications

• 1+ years of clinical trial monitoring experience required.
• Proficiency in EDC systems and regulatory compliance knowledge.

Responsibilities

• Manage clinical trial sites, ensuring protocol adherence.
• Conduct monitoring visits and prepare detailed reports.

Skills

Clinical Trial Monitoring

Electronic Data Capture (EDC)

Good Clinical Practice (GCP)

Regulatory Compliance

Communication Skills

Organizational Skills

Education

GCP Certification

Experience in Clinical Trials

Tools

Clinical Trial Management Software

Regulatory Compliance Tools

Job description

This range is provided by Lumicity. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$85,000.00/yr - $100,000.00/yr

Direct message the job poster from Lumicity

• Participate in the selection, qualification, initiation, activation, and close-out of clinical trial sites.
• Ensure smooth coordination and management of investigative sites, ensuring adherence to the study protocol and compliance with regulatory requirements.
• Oversee the preparation, collection, and distribution of Trial Master File (TMF) documents, ensuring the maintenance of complete and accurate regulatory files at investigational sites.
• Regularly review site documentation and regulatory files to ensure compliance with protocol and regulatory requirements.
• Conduct interim monitoring visits on-site and remotely, performing both clinical site and data monitoring activities.
• Prepare detailed monitoring visit reports to assess site performance, regulatory compliance, and clinical data integrity.
• Evaluate clinical trial data, identify discrepancies, and coordinate with sites to resolve data queries effectively.
• Perform on-site and remote source data verification to ensure that clinical data aligns with source documents and regulatory requirements.
• Manage and support the close-out of clinical trial sites, ensuring that all necessary documentation and regulatory requirements are met.
• Serve as the primary point of contact for investigators and site staff, fostering strong relationships to promote effective communication and compliance.
• Regularly report on progress, challenges, and site performance to the Clinical Trials Manager.
• Willingness to travel to investigational sites as required (70-80% of the time) for monitoring visits and site activities.

JOB QUALIFICATION REQUIREMENTS:

• Minimum of 1 year of field-based clinical trial monitoring experience or equivalent experience in clinical trials project management.
• Proficiency with electronic data capture (EDC) systems and familiarity with industry-standard software tools.
• Knowledge of key areas of compliance, including regulatory requirements, GxP, and clinical trial guidelines.
• In-depth understanding of Good Clinical Practice (GCP), Good Documentation Practice (GDP), and FDA Code of Federal Regulations.
• GCP certification is required, with familiarity in adhering to regulatory standards across clinical trial activities.
• Strong verbal and written communication skills, particularly in working with clinical investigators and study site staff to resolve issues and ensure protocol adherence.
• Exceptional organizational skills with high attention to detail, ensuring the successful tracking and management of clinical trial sites, documents, and data.
• Ability to independently manage, prioritize, and report on progress across multiple clinical trial sites and tasks simultaneously.
• Proven ability to build and maintain professional relationships with investigational sites, enhancing collaboration, and ensuring ongoing compliance throughout the trial.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Full-time

Job function

• Job function

  Science

• Industries

  Medical Equipment Manufacturing

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Inferred from the description for this job

Medical insurance

401(k)

Vision insurance

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