Research Assistant II

This is a fully remote position, open to applicants in Colorado.

📋 Description

• Act as a versatile resource to carry out a range of activities that support the execution and management of projects and programs.

• Provide support to Research Operations, Endpoint and Specialty Services, Site Operations, Data Management, Quality Control, and Trial Master File according to business requirements.

• Collaborate closely with team members to ensure timely completion of deliverables and resolution of issues.

• Execute general administrative duties including filing, copying, and preparing shipments for assigned projects.

• Upload critical documents into the eTMF system.

• Conduct quality control reviews and facilitate the submission of project-specific documentation to the Trial Master File.

• Carry out ALCOA+ checks on documents uploaded into the eTMF system.

• Attend project, program, functional area, and general CPC meetings as needed.

• Assist in the preparation of Master Plans, Resource Materials, Source Documentation, Meeting Minutes, and Trial Master File submissions.

• Coordinate and monitor the receipt of project supplies to study sites.

• Track receipt, entry, upload, reviews, and feedback concerning endpoint testing at investigational sites.

• Aid in the development, administration, and tracking of project-specific training.

• Manage email reconciliation and export during study close-out.

• Gather 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.

• Act as one of the main points of contact for investigational sites.

• Conduct query management, report generation, and data reconciliation tasks.

• Support User Acceptance Testing (UAT).

• Manage user access requests, including user reconciliation.

• Perform general data reviews of study data in EDCs.

⛳️ Requirements

• GED or High School Diploma is required.

• Nursing or a bachelor’s degree is preferred.

• A minimum of 1 year of experience in a clinical research (or similar) environment.

• A higher degree may be considered in lieu of experience.

• Proven ability to complete core tasks with minimal guidance while reliably escalating less routine assignments for assistance.

• Comprehensive knowledge of Good Clinical Practice guidelines and relevant FDA and ICH regulations for conducting clinical drug trials.

• Strong understanding of the drug development process.

• Proficient in MS Office, especially in spreadsheet databases and word-processing.

• Excellent communication and organizational abilities.

• Exceptional attention to detail.

• Capability to work collaboratively with others to foster group effort and achievement.

• Ability to rapidly shift priorities while maintaining accuracy and ensuring timely task completion.

• Skill in managing conflicts and effectively resolving problems.

• Ability to identify priorities and seek direction for the accomplishment of daily tasks.

🏝️ Benefits

• Comprehensive benefits package (including 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.