Research Assistant II

CPC Clinical Research • Aurora, CO

2d

About The Position

The Research Assistant II serves as a floating resource supporting the execution and management of projects and programs. Depending on business needs, the role may assist Research Operations, Endpoint and Specialty Services, Site Operations, Data Management, Quality Control, or Trial Master File functions. The position works with team members to complete deliverables on time and resolve issues, and supports investigational sites, CPC staff, and sponsors through documentation, data, and project coordination activities.

Requirements

• GED or high school diploma.
• At least 1 year of experience working in a clinical research or similar setting; a higher degree may be considered in lieu of experience.
• Demonstrated ability to complete core tasks with minimal direction and escalate less routine assignments for guidance.
• Thorough knowledge of Good Clinical Practice guidelines and applicable FDA and ICH regulations for conducting clinical drug trials.
• Good understanding of the drug development process.
• Proficiency in Microsoft Office, particularly spreadsheet databases and word-processing.
• Excellent communication and organizational skills.
• Strong attention to detail.
• Ability to work collaboratively to promote group effort and achievement.
• Ability to shift priorities quickly while maintaining accuracy and timely task completion.
• Ability to manage conflicts and resolve problems effectively.
• Ability to discern priorities and obtain direction to accomplish day-to-day tasks.

Nice To Haves

• Nursing degree or bachelor's degree.

Responsibilities

• Provide support across assigned functional areas based on business needs.
• Work with team members to complete deliverables on time and resolve issues.
• Perform general administrative tasks, including filing, copying, and preparing project shipments.
• Upload essential documents into the eTMF system.
• Conduct quality control reviews of project-specific documentation and support submission of documents to the Trial Master File.
• Perform ALCOA+ checks on documents uploaded into the eTMF system.
• Participate in project, program, functional area, and general CPC meetings as required.
• Assist with preparing Master Plans, resource materials, source documentation, and meeting minutes, and submitting documents to the Trial Master File.
• Coordinate and track receipt of project supplies at study sites.
• Assist with tracking receipt, entry, upload, review, and feedback to investigational sites for endpoint testing.
• Assist with developing, administering, and tracking project-specific training.
• Manage email reconciliation and export at study close-out.
• Collect and review investigational site documentation and process it as directed.
• Correspond with investigational sites, CPC staff, and sponsors to resolve data queries and collect outstanding documentation.
• Serve as a primary point of contact for investigational sites.
• Perform query management, report generation, and data reconciliation tasks.
• Assist with User Acceptance Testing (UAT).
• Manage user access requests, including user reconciliation.
• Perform general review of study data in EDCs.

Benefits

• Comprehensive benefits package, including medical, dental, vision, life, short-term disability, and long-term disability coverage.
• Matching 401(k) plan, matching dollar for dollar up to 4% of eligible compensation, fully vested immediately.
• 11 paid holidays.
• 15–25 vacation days based on years of service.
• Paid sick time accrued at 2.67 hours bi-weekly, up to a maximum of 80 hours.
• Flexible and remote work schedules.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED