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 required.

• Organize travel plans for both domestic and international SEEVs.

• Execute SEEVs across domestic and international locations, providing hands-on training for site staff regarding endpoint data collection, reviewing source documents/reference tools for endpoint data, and assessing equipment in line with the CPC SOP.

• Generate thorough, precise, and timely SEEV reports while sharing findings with internal study teams.

• Report site-related issues identified during SEEVs to the designated Clinical Trial Manager or Project Manager.

• Support Clinical Trial Managers and CRAs in addressing enrollment and retention challenges for international sites.

• Assist in monitoring study recruitment and enrollment metrics for sites needing further intervention.

• Liaise with site personnel to address concerns related to missing, incomplete, or inaccurate submissions.

• Engage in discussions concerning site compliance, performance trends, and necessary corrective measures.

• Act as a point of contact for site inquiries when CRAs or CTMs are unavailable.

• Aid in the review and upkeep of site regulatory and study documentation.

• Help ensure that documentation in CTMS, TMF, and other study systems is accurate.

• Attend project team meetings and assist in resolving site-related issues.

• Carry out other tasks as assigned.

⛳️ Requirements

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

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

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

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

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

• Willingness to travel up to 80%, including international trips.

• Capability to manage multiple tasks and adjust to shifting priorities.

• Ability to work autonomously and use sound judgment to escalate issues appropriately.

🏝️ 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