Senior Clinical Research Associate – Central/ Midwest Internship

Job Responsibilities

• Perform and coordinate assigned aspects of the clinical monitoring process according to GCPs and SOPs.
• Conduct site visits to ensure protocol and regulatory compliance and prepare required documentation.
• Develop collaborative relationships with investigative sites and study vendors.
• Track enrollment status reports to meet study goals.
• Provide mentoring/training for less experienced CRAs.
• Assist Clinical Study Manager with monitoring visit report review and other managerial tasks.
• Conduct study-specific training with project team.
• Develop study-specific monitoring tools for efficient data review.
• Perform Serious Adverse Event (SAE) reconciliation and resolve discrepancies.
• Review data reports and ensure data collection meets contractual guidelines.
• Collaborate with Clinical Trial Oversight Managers to manage site trends and ensure quality standards.
• Ensure timely delivery of study milestones through collaboration with clinical study sites.
• Provide support for audits/inspections preparation/responses and quality issues.
• Assist with other clinical responsibilities within the scope of the role.

Requirements

• Bachelor’s degree in a relevant scientific discipline.
• Minimum 4-6 years of relevant Clinical Operations experience.
• Minimum 3-4 years of monitoring experience in the pharmaceutical or CRO Industry.
• Excellent communication, interpersonal, and organizational skills.
• Ability to prioritize and multitask.
• Knowledge of clinical trial processes and ICH guidelines.
• Proficiency in Microsoft Word, Excel, PowerPoint, Outlook, and industry CTMS and data management systems.
• Up to 40-60% travel required.

Benefits

• Salary Range: $97,100.00 – $132,100.00 annually.
• Comprehensive benefits package including Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
• Opportunity for discretionary equity awards and participation in the Employee Stock Purchase Plan.
• Equal opportunity employer promoting diversity and inclusion.