Research Assistant II

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

📋 Description

• Act as a versatile resource to carry out various activities that aid in the execution and management of projects and programs.

• Offer support across Research Operations, Endpoint and Specialty Services, Site Operations, Data Management, Quality Control, and Trial Master File functions according to business demands.

• Collaborate with team members to ensure the prompt completion of deliverables and address any issues that arise.

• Handle administrative duties such as filing, copying, and preparing shipments for assigned projects.

• Upload crucial documents into the eTMF system.

• Conduct quality control reviews of project documentation and assist with Trial Master File submissions.

• Execute ALCOA+ checks on documents uploaded to the eTMF system.

• Participate in project, program, functional area, and general CPC meetings as necessary.

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

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

• Track the receipt, entry, upload, review, and feedback process of endpoint testing to investigational sites.

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

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

• Gather and assess investigational site documentation and process it as directed.

• Communicate with investigational sites, CPC staff, and sponsors to resolve data queries and gather outstanding documentation.

• Act as the primary contact for investigational sites.

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

• Assist with User Acceptance Testing (UAT).

• Manage user access requests, including user reconciliation.

• Conduct general data reviews of study data in EDCs.

⛳️ Requirements

• GED or High School Diploma is required.

• Nursing or bachelor’s degree is preferred.

• At least 1 year of experience in a clinical research (or similar) environment.

• A higher degree may be accepted in place of experience.

• Proven ability to complete essential tasks with minimal supervision, while reliably escalating for guidance on less routine assignments.

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

• Solid understanding of the drug development process.

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

• Exceptional communication and organizational abilities.

• Strong attention to detail.

• Capability to collaborate with others in a manner that fosters group effort and achievement.

• Flexibility to quickly adjust priorities while maintaining accuracy and timely task completion.

• Skill in managing conflicts and resolving issues effectively.

• Ability to prioritize tasks and seek direction to accomplish daily responsibilities.

🏝️ 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.