Remote Clinical Research Assistant II — Data & Trials Support

CPC Clinical Research; Aurora (CO); Remote; USD 45,000 - 65,000; Full time

Benefits offered by this job

Comprehensive benefits package

Matching 401(k) up to 4%

11 paid holidays

15-25 vacation days based on service

Paid sick time

Flexible and remote work schedules

Job summary

CPC Clinical Research is seeking a proactive Clinical Research Support professional in Colorado to assist across research operations, data management, and trial documentation. You will upload documents to the eTMF, perform ALCOA+ checks, and help prepare Master Plans and Meeting Minutes for Trial Master File submissions.

You will coordinate with investigational sites and CPC staff, manage data queries, and support user testing and access requests.

Qualifications

• GED or HS Diploma required; Nursing or bachelor’s degree preferred.
• Minimum of 1 year of experience in a clinical research (or similar) setting.
• Thorough knowledge of Good Clinical Practice guidelines and FDA/ICH regulations.
• Proficiency in MS Office, particularly spreadsheets and word-processing.
• Excellent communication and organizational skills.
• Great attention to detail.
• Ability to shift priorities quickly while ensuring accuracy.
• Ability to manage conflicts and resolve problems.
• Ability to discern priorities and obtain direction for day-to-day tasks.

Responsibilities

• Serve as a floating resource to perform activities in support of projects and programs.
• Provide assistance to Research Operations, Endpoint and Specialty Services, Site Operations, Data Management, Quality Control, and Trial Master File as needed.
• Work with team members to ensure timely deliverables and issue resolution.
• Perform general administrative tasks and prepare shipments for projects.
• Upload essential documents into the eTMF system and perform ALCOA+ checks.
• Participate in CPC meetings as required.
• Assist in Master Plans, Resource Materials, Source Documentation, and Meeting Minutes submissions to the Trial Master File.
• Coordinate and track receipt of project supplies to study sites.
• Assist in tracking endpoint testing data, training, and email reconciliation.
• Manage user access requests and perform data review in EDC systems.

Skills

Attention to detail

Excellent communication

Organizational skills

Team collaboration

Prioritization

Conflict resolution

Direction seeking

Education

HS Diploma

Bachelor or nursing degree preferred

Tools

MS Office

Job description

CPC Clinical Research is seeking a proactive Clinical Research Support professional in Colorado to assist across research operations, data management, and trial documentation. You will upload documents to the eTMF, perform ALCOA+ checks, and help prepare Master Plans and Meeting Minutes for Trial Master File submissions.

You will coordinate with investigational sites and CPC staff, manage data queries, and support user testing and access requests.