Clinical & Endpoint Research Associate

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

📋 Description

• Reach out to study sites and arrange SEEVs as assigned.

• Organize travel logistics for both domestic and international SEEVs.

• Execute SEEVs on a domestic and international scale, providing hands-on training to site staff on endpoint data collection, reviewing source documents/reference tools for endpoint data, and assessing equipment per the CPC SOP.

• Produce thorough, accurate, and prompt SEEV reports and relay findings to internal study teams.

• Raise any site concerns identified during SEEVs to the relevant Clinical Trial Manager or Project Manager.

• Aid Clinical Trial Managers and CRAs with enrollment and retention issues for international sites.

• Facilitate the monitoring of study recruitment and enrollment metrics for sites that need extra intervention.

• Interact with site personnel to address issues related to missing, incomplete, or erroneous submissions.

• Engage in discussions regarding site compliance, performance trends, and necessary corrective actions.

• Act as a supportive contact for site inquiries when CRAs or CTMs are not available.

• Assist in the review and upkeep of site regulatory and study documents.

• Contribute to ensuring precise documentation in CTMS, TMF, and other study systems.

• Participate in project team meetings and aid in resolving site issues.

• Undertake additional tasks as assigned.

⛳️ Requirements

• A Bachelor’s degree or nursing degree is preferred.

• 2–4 years of experience in a clinical research environment.

• Familiarity with Good Clinical Practice (GCP) and relevant FDA and ICH regulations.

• Excellent organizational, communication, and problem-solving capabilities.

• Proficient in Microsoft Office (Outlook, Word, Excel).

• Willingness to travel up to 80%, including internationally.

• Ability to juggle multiple tasks and adjust to shifting priorities.

• Capacity to work independently and exercise sound judgment in appropriately escalating issues.

🏝️ 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