Research Assistant II

Responsibilities

• Serve 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, may provide assistance to the following functional areas:
• 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

Preferred

• Nursing or bachelor's degree

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)
• Flexible and remote work schedules
• Founded in 1989 by the University of Colorado, CPC has two divisions.
• Aurora, Colorado, USA
• https://cpcclinicalresearch.org/
• Growth Stage
• Recent News
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Qualifications

• GED or HS Diploma
• Minimum of 1 years of experience working in a clinical research (or similar) setting. Higher degree may be considered in lieu of experience
• 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
• Nursing or bachelor's degree
• Minimum of 1 years of experience working in a clinical research (or similar) setting. Higher degree may be considered in lieu of experience.

Required skills

• Clinical Research, Drug Development, FDA and ICH Clinical Trial Regulations

Preferred skills

• Nursing or bachelor's degree

Experience

• 1+ years