Research Assistant II (Internal Posting)- 2 positions

CPC Clinical Research • Aurora, CO

5d • Hybrid

About The Position

This role serves as a floating resource to perform a variety of activities in support of the execution and management of projects and programs. Based on business needs, the Research Assistant II may provide assistance to functional areas such as Research Operations, Endpoint and Specialty Services, Site Operations, Data Management, Quality Control, and Trial Master File. The position requires close collaboration with team members to ensure timely completion of deliverables and resolution of issues. Responsibilities include administrative tasks, document management within the eTMF system, quality control reviews, and serving as a point of contact for investigational sites.

Requirements

• GED or HS Diploma required.
• Minimum of 1 years of experience working in a clinical research (or similar) setting.
• Demonstrated ability to complete core tasks with minimal direction, while reliably escalating for guidance on less routine assignments.
• Thorough knowledge of the Good Clinical Practice guidelines and the applicable FDA and ICH regulations for conducting clinical drug trials.
• Good understanding of the drug development process.
• Proficiency in MS Office, particularly spreadsheet databases and word-processing.
• Excellent 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.
• Ability to discern priorities and obtain direction to accomplish day-to-day tasks.

Nice To Haves

• Nursing or bachelor’s degree preferred.
• Higher degree may be considered in lieu of experience.

Responsibilities

• Serve as a floating resource to perform a variety of activities in support of the execution and management of projects and programs.
• Provide assistance to functional areas including Research Operations, Endpoint and Specialty Services, Site Operations, Data Management, Quality Control, and Trial Master File.
• Work closely with other team members to ensure timely completion of deliverables and resolution of issues.
• Perform a variety of general administrative tasks such as filing, copying, and preparation of shipments for assigned projects.
• Upload essential documents into eTMF system.
• Perform quality control reviews of project-specific documentation and support submission of documents to the Trial Master File.
• Perform ALCOA+ checks of documents uploaded into eTMF system.
• Participate in project, program, functional area and general CPC meetings as required.
• Assist in the preparation of Master Plans, Resource Materials, Source Documentation, Meeting Minutes, and submission of documents to the Trial Master File.
• Coordinate and track receipt of project supplies to study sites.
• Assist in tracking receipt, entry, upload, reviews and feedback to investigational sites of endpoint testing.
• Assist in the development, administration, and tracking of project specific training.
• Manage email reconciliation and export at study close-out.
• Collect and review investigational site documentation and process as directed.
• Correspond with investigational sites, CPC staff and sponsors to rectify 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 data review of study data in EDCs.

Benefits

• Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.)
• Matching 401(k) plan (dollar for dollar up to 4% of your eligible compensation, fully vested immediately)
• 11 paid holidays
• 15 - 25 vacation days based on years of service
• Paid sick time (2.67 hours accrued bi-weekly up to a maximum of 80 hours)
• Monthly fun events (e.g. team building activities, games, charitable events, potlucks, picnics)
• Flexible and remote work schedules

What This Job Offers

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