Lead Clinical Research Associate - Trial Oversight

ProTrials Research, Inc.; United States; Hybrid; USD 110,000 - 160,000; Full time

Job summary

ProTrials Research, Inc. is seeking a Contract Lead Clinical Research Associate to lead the CRA team and ensure accurate initiation, enrollment, conduct, and completion of studies.

You will provide direction, monitor performance, and coordinate with investigators, sites, and vendors to maintain quality. The role requires a strong background in clinical research, FDA/GCP knowledge, and the ability to travel both remotely and on-site as needed.

Qualifications

• RN, Bachelor, or advanced degree in biological sciences or related field
• Proven CRA experience or related monitoring background
• Strong knowledge of FDA regulations and GCP
• Excellent communication, organization, and problem-solving skills
• Ability to travel and perform remote and on-site monitoring as needed
• Proficiency with CTMS, data management and document control

Responsibilities

• Provide study oversight as liaison between CRAs, site staff, investigators, clients and vendors.
• Ensure CRA monitoring activities meet SOPs, regulations, GCP, KPIs and study requirements.
• Develop and manage clinical plans and monitoring timelines; ensure compliance.
• Create annotated visit report templates and site management documents.
• Support training and development of team members and track training.
• Guide CRAs, CTAs and CROs regarding monitoring and audits; review site visit reports.
• Manage TMF/eTMF oversight and QA responsibilities.
• Track SAEs, protocol deviations, enrollments and study materials as required.

Skills

Communication

Organization

Prioritization

Presentation

Discretion

Accuracy

Travel readiness

Team leadership

Education

RN, Bachelor, or advanced degree in biological sciences or related field

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

ProTrials Research, Inc. is seeking a Contract Lead Clinical Research Associate to lead the CRA team and ensure accurate initiation, enrollment, conduct, and completion of studies.

You will provide direction, monitor performance, and coordinate with investigators, sites, and vendors to maintain quality. The role requires a strong background in clinical research, FDA/GCP knowledge, and the ability to travel both remotely and on-site as needed.