Research Assistant I

$40,123 - $47,840/Yr

CPC Clinical Research - Aurora, CO

Full-time - Entry Level

Remote - Aurora, CO

About the position

The Research Assistant I position at CPC Clinical Research involves supporting the execution and management of various clinical research projects. The role requires strong organizational skills, adaptability, and attention to detail, as the assistant will perform a variety of tasks across different functional areas, including data management, quality control, and communication with investigational sites.

Responsibilities

• Serve as a floating resource to perform a variety of activities in support of the execution and management of projects and programs.
• Assist in the preparation of Master Plans, Resource Materials, Source Documentation, Meeting Minutes, and submission of documents to the Trial Master File.
• Assist in the administration and tracking of project-specific training.
• Correspond with investigational sites, CPC staff, and sponsors to rectify data queries and collect outstanding documentation.
• Assist in tracking receipt, entry, upload, reviews, and feedback to investigational sites of endpoint testing.
• Assist with the printing, collation, and distribution of study materials to project team members, sponsors, and sites.
• Assist with query management.
• Assist with User Acceptance Testing (UAT) and manage user access requests (including user reconciliation).
• Work closely with other team members to ensure timely completion of deliverables and resolution of issues.
• Participate in project, program, functional area, and general CPC meetings as required.
• Adhere to CPC SOPs, Good Clinical Practice guidelines, and applicable federal, state, and local regulations.
• Serve as a study coordinator for select projects as needed.

Requirements

• GED or HS Diploma required.
• Minimum of 1 year of experience working in a clinical research setting or commensurate experience.
• Basic knowledge of the Good Clinical Practice guidelines and the applicable FDA and ICH regulations for conducting clinical drug trials.
• Basic understanding of the drug development process.
• Proficiency in MS Office, particularly spreadsheet databases and word-processing.
• Good communication and organizational skills.
• Great attention to detail.
• Ability to work with others in a manner that promotes group effort and achievement.
• Ability to shift priorities quickly while ensuring accuracy and timely completion of tasks.
• Ability to manage conflicts and resolve problems effectively.

Nice-to-haves

• Nursing or bachelor's degree preferred.

Benefits

• 401(k) matching
• Dental insurance
• Disability insurance
• Health insurance
• Paid holidays
• Paid sick time
• Vision insurance