Clinical Research Associate (CRA)

United Pharma; United States; On-site; USD 90,000 - 130,000; Full time

Job summary

United Pharma is seeking a Clinical Research Associate to monitor trial sites, ensure GCP/FDA compliance, and support multi-region program execution. This field-based role requires extensive site visits and up to 70% travel nationwide, collaborating with cross-functional teams to drive study milestones.

The candidate will oversee site initiation through closeout, manage essential trial documentation, and escalate issues as needed, leveraging CTMS/eTMF/eCRF tools and strong organizational skills.

Qualifications

• Minimum of 7 years of clinical monitoring experience in pharma/biotech/CRO
• Bachelor's degree in a scientific or healthcare-related field
• Strong knowledge of clinical research operations, FDA regulations, ICH-GCP, and trial conduct
• Excellent organizational, communication, problem-solving, and relationship-management skills
• Experience with CTMS/eTMF/eCRF and MS Office
• Ability to manage multiple priorities with minimal supervision
• Willingness to travel up to 70% with no travel restrictions

Responsibilities

• Conduct site monitoring visits (qualification, initiation, interim monitoring, closeout)
• Ensure protocol compliance, data quality, and GCP adherence
• Serve as primary contact for investigative sites and study teams
• Review and maintain Investigator Site Files and trial records
• Prepare monitoring reports and escalate significant findings
• Track site performance, recruitment progress, and milestones
• Support investigator training and study meetings
• Collaborate with internal teams, vendors, and site personnel

Skills

Attention to detail

Strong communication

Relationship management

Problem solving

Multi-tasking

Education

Bachelor's degree in a scientific or healthcare-related field

Tools

CTMS

eTMF

eCRF

Microsoft Office

Job description

Work Arrangement: Field-based / Travel role - approximately 50-70% onsite at clinical trial sites; up to 70% travel required. Candidates must have no travel restrictions.

Job Summary

The Clinical Research Associate (CRA) is responsible for monitoring and managing clinical trial sites to ensure compliance with study protocols, Good Clinical Practice (GCP), FDA regulations, and sponsor standards. This role supports study execution from site initiation through closeout while serving as a key point of contact for investigative sites and cross-functional study teams. This is a large-scale, multi-region clinical trial program offering the opportunity to work across a substantial CRA team supporting a high volume of active sites nationwide.

Responsibilities

• Conduct site monitoring visits, including site qualification, initiation, interim monitoring, and closeout activities.
• Ensure protocol compliance, data quality, and adherence to GCP and regulatory requirements.
• Serve as the primary point of contact for assigned investigative sites, communicating study updates, issues, and risks.
• Review and maintain essential study documentation, including Investigator Site Files and trial records.
• Prepare monitoring reports and upscale significant findings or site issues as appropriate.
• Track site performance, recruitment progress, and study milestones.
• Support investigator training, study meetings, and other clinical trial activities.
• Collaborate with internal teams, vendors, and site personnel to support successful study execution.

Required Qualifications

• Minimum of 7 years of clinical monitoring experience within pharmaceutical, biotechnology, or CRO environments.
• Bachelor's degree in a scientific or healthcare-related field.
• Strong knowledge of clinical research operations, FDA regulations, ICH-GCP guidelines, and clinical trial conduct.
• Excellent organizational, communication, problem-solving, and relationship-management skills.
• Experience with CTMS, eTMF, eCRF platforms, and Microsoft Office applications.
• Ability to manage multiple priorities with minimal supervision in a fast-paced environment.
• Willingness and ability to travel up to 70%, with no travel restrictions.

Preferred Qualifications

• CNS (Central Nervous System) clinical trial experience.