Clinical Research Associate

About this role

• **Position Summary:** The In-House CRA will support the planning, monitoring, and execution of clinical trials to ensure compliance with study protocols, Good Clinical Practice (GCP), and regulatory requirements.
• This role will focus on remote and on-site monitoring activities, including Source Data Verification (SDV), clinical data review, and site support, while also contributing to in-house clinical operations activities.
• **Responsibilities:** * Conduct remote and on-site monitoring activities in accordance with the monitoring plan, ensuring high-quality data and protocol compliance.
• * Review eCRFs and source data, resolve discrepancies, and follow up with sites to ensure timely data cleaning and query resolution.
• * Identify, document, and escalate data quality issues, protocol deviations, and site risks to Clinical Operations leadership.
• * Perform Investigator Site File (ISF) reviews, tracking and addressing outstanding issues.
• * Oversee essential document management during all study phases and ensure audit-readiness Trial Master File (TMF).
• * Prepare, review, and file monitoring visit reports, follow-up letters, and study documentation.
• * Ensure compliance with study protocols, GCP, SOPs, and applicable regulatory requirements.
• * Support site initiation, training, ongoing site communication and study closeout.
• * Support vendor oversight activities, including coordination with central labs, and other study vendors as applicable.
• * Attend meetings and teleconferences and generate and distribute agendas and minutes.
• * Other study related tasks as required.
• **Qualifications:** * Minimum of a bachelor's degree in a scientific or health care discipline preferred.
• * 2-5+ years of CRA experience with direct involvement in clinical trials from start-up through closeout within pharmaceutical, biotechnology, or CRO environments.
• * Hands-on experience performing SDV and site monitoring activities.
• * Strong working knowledge of ICH-GCP, FDA regulations, and clinical trial operations.
• * Highly effective team player with exceptional interpersonal skills building relationships with clinical trial sites.
• * Ability to work independently with little oversight and attention to detail and results oriented.
• * Experience using EDC, CTMS, and eTMF systems.
• * Excellent organizational skills with the ability to manage multiple studies and priorities.
• * This position requires some travel.
• Job Type: Contract position (25% FTE) Work Location: Remote with occasional travel required Pay: From $20,000.00 per year Benefits: * Flexible schedule Application Question(s): * This is a contract position starts at 25% FTE.
• More hours may be needed depending on the monitoring need.
• The position requires availability during business hours and may not be compatible with concurrent full-time employment.
• Could you please let me know whether you would be open to transitioning away from your current full-time role (if applicable) in order to take on this contract opportunity, should there be mutual interest?
• Work Location: Hybrid remote in Tucson, AZ 85719

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