Sr. CRA

Senior Clinical Research Associate (CRA) | W2 Contract Locations: Overland Park, KS or Cypress, CA Employment Type: W2 Contract Schedule: Part-time, approximately 20–24 hours per week on average, with flexibility based on study needs Work Arrangement: Local onsite monitoring with occasional travel to external clinical research sites

Position Overview

We are seeking experienced Senior Clinical Research Associates (CRAs) to support Phase I clinical trials involving healthy volunteers. This opportunity is ideal for a self-sufficient CRA with hands‑on early‑phase clinical monitoring experience who can independently manage monitoring activities across clinical research facilities and external investigator sites. The successful candidate will have direct experience monitoring Phase I healthy‑volunteer studies, strong knowledge of Good Clinical Practice (GCP), and the ability to manage site relationships, monitoring visits, and study documentation with minimal oversight. This is a flexible, part-time contract opportunity with fluctuating workloads based on clinical study requirements.

Key Responsibilities

• Independently conduct site qualification, initiation, interim, and close‑out monitoring visits in accordance with study protocols, monitoring plans, and ICH‑GCP guidelines.
• Monitor Phase I healthy‑volunteer clinical trials, including dose observation visits, participant eligibility reviews, and protocol compliance assessments.
• Perform Source Data Review (SDR) and Source Data Verification (SDV), as applicable, to ensure data integrity, participant safety, and regulatory compliance.
• Review informed consent documentation, adverse event reporting, protocol deviations, Investigator Site Files, and investigational product records.
• Conduct unblinded monitoring activities when assigned, including pharmacy and investigational product documentation reviews.
• Independently schedule and coordinate monitoring visits, manage external investigator‑site relationships, and communicate with site personnel.
• Prepare Clinical Monitoring Plans and Site Initiation Visit (SIV) presentations using established templates.
• Identify, document, elevate, and follow up on monitoring findings and compliance issues.
• Prepare accurate monitoring visit reports and maintain study documentation within established timelines.
• Collaborate with clinical operations teams, investigators, and study stakeholders to support successful trial execution.

Required Qualifications

• Minimum 3–5 years of clinical research monitoring experience, with demonstrated ability to perform senior-level CRA responsibilities independently.
• Direct Phase I healthy‑volunteer clinical monitoring experience is required. Phase I oncology experience alone does not satisfy this requirement.
• Experience independently monitoring and managing external investigator sites, including direct communication and coordination with site personnel.
• Hands‑on experience with Phase I monitoring activities, including dose observation visits and participant eligibility assessments.
• Strong knowledge of ICH‑GCP guidelines, clinical trial regulations, and monitoring best practices.
• Current GCP training certification or documented completion is required.
• Experience conducting SDR, SDV, and clinical monitoring documentation reviews.
• Ability to prepare Clinical Monitoring Plans and SIV materials using established templates.
• Strong organizational, communication, documentation, and time‑management skills.
• Ability to work independently with minimal supervision and adapt to changing study schedules.
• Must reside within commuting distance of Overland Park, KS or Cypress, CA and be available for onsite monitoring and occasional travel.

Preferred Qualifications

• Experience conducting unblinded clinical monitoring visits, particularly involving pharmacy or investigational product activities.
• Previous monitoring experience within dedicated Phase I clinical research facilities.
• Familiarity with integrated eSource and Electronic Data Capture (EDC) systems, including ClinSpark.
• Experience supporting both internal clinical research facilities and external investigator sites.

Additional Information

This position offers an average utilization of approximately 50–60%, with hours fluctuating based on study timelines and monitoring requirements. Candidates should be comfortable with variable scheduling and have the flexibility to increase availability during busy periods. Monitoring activities may require full‑day onsite visits or multiple consecutive days depending on study needs. Travel expenses associated with required external‑site visits are reimbursable in accordance with applicable policies. We are seeking experienced CRAs who can contribute immediately, independently manage assigned responsibilities, and maintain high standards of clinical monitoring quality and regulatory compliance.