Research Assistant II

CPC Clinical Research • Aurora, CO

19h • $21 - $24

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 closely with team members to complete deliverables on time and resolve issues, and may serve as a primary point of contact for investigational sites.

The role supports project administration and documentation, including preparing materials and shipments, uploading and quality-checking documents in the eTMF system, conducting ALCOA+ checks, and assisting with Trial Master File submissions. It also supports site coordination, endpoint-testing tracking, project-specific training, close-out email reconciliation, investigational-site documentation, query resolution, data review and reconciliation, report generation, user access administration, and User Acceptance Testing.

CPC offers a comprehensive benefits package, a matching 401(k) plan, paid holidays, vacation and sick time, and flexible and remote work schedules. The posting remains open until filled; applicants are encouraged to apply by October 28, 2026 for best consideration.

Requirements

• GED or high school diploma required.
• At least 1 year of experience working in a clinical research or similar setting; a higher degree may be considered in lieu of experience.
• Ability to complete core tasks with minimal direction and reliably escalate less routine assignments for guidance.
• Thorough knowledge of Good Clinical Practice guidelines and applicable FDA and ICH regulations for 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 completion of tasks.
• 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 or bachelor's degree preferred.

Responsibilities

• Serve as a floating resource supporting project and program execution and management across functional areas as business needs require.
• 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 and perform quality control reviews and ALCOA+ checks.
• Support submission of documents to the Trial Master File.
• Participate in project, program, functional-area, and general CPC meetings as required.
• Assist with preparing Master Plans, Resource Materials, Source Documentation, and Meeting Minutes.
• Coordinate and track receipt of project supplies at study sites.
• Track 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.
• Communicate with investigational sites, CPC staff, and sponsors to resolve data queries and collect outstanding documentation.
• Serve as one of the primary points 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.
• 401(k) plan with dollar-for-dollar matching 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