Contract Lead Clinical Research Associate - Remote & Onsite

ProTrials Research, Inc.; Oregon (WI); Hybrid; USD 110,000 - 170,000; Full time

Job summary

ProTrials Research, Inc. is seeking a Contract Lead Clinical Research Associate (LCRA) to lead the CRA team across studies, ensuring timely initiation, enrollment, conduct, and completion. The LCRA provides project management support, ensures adequate monitoring resources, and identifies quality issues for action plans.

The role involves directing site oversight, maintaining SOP/compliance, and guiding CRAs, CTAs, and CROs in monitoring, audits, and document control, with travel as required.

Qualifications

• Strong communication, organization, prioritization, presentation, discretion and accuracy are required.
• Previous CRA experience is preferred.
• Solutions-oriented approach to problem solving is essential.
• Familiarity with medical/pharmaceutical industry terminology and practices is expected.
• Extensive knowledge of FDA regulations and their practical implementation.
• Willingness to travel and perform remote and on-site monitoring as needed.

Responsibilities

• Provide study oversight as the primary liaison between CRAs, staff, investigators, coordinators, client personnel, and vendors.
• Ensure CRA monitoring activities comply with SOPs, regulations, and study requirements.
• Develop and manage clinical plans, timelines, and monitoring intervals; review reports and data for discrepancies.
• Create annotated visit report templates and site management documents.
• Support training and development of team members and maintain training documentation.
• Guide CRAs, CTAs, and CROs on monitoring, co-monitoring, and audits; review site visit reports.
• Oversee TMF/eTMF filing and quality control.
• Track safety events, protocol deviations, enrollment, and investigational supplies.
• Conduct qualification, initiation, interim, and close-out visits and prepare visit reports.

Skills

Communication

Organization

Prior CRA experience

Problem solving

Attention to detail

Discretion

Education

RN or Bachelor or advanced degree in biological sciences

Job description

ProTrials Research, Inc. is seeking a Contract Lead Clinical Research Associate (LCRA) to lead the CRA team across studies, ensuring timely initiation, enrollment, conduct, and completion. The LCRA provides project management support, ensures adequate monitoring resources, and identifies quality issues for action plans.

The role involves directing site oversight, maintaining SOP/compliance, and guiding CRAs, CTAs, and CROs in monitoring, audits, and document control, with travel as required.