Senior Clinical Research Associate, Texas or Arizona

This is a fully remote position, open to applicants in Arizona, +1 more state.

📋 Description

• Oversee assigned Investigator sites while fostering positive relationships with site personnel.

• Prepare for and carry out Pre-Study, Initiation, Interim, and Closeout monitoring visits.

• Assist in achieving study milestones such as site activation, DSMB meetings, and database lock.

• Conduct centralized monitoring between on-site visits to address action items, ensure study data quality and flow, and manage study risks.

• Ensure quality and ALCOA+ compliant documentation, including monitoring visit reports, centralized monitoring reports, site contact reports, and Trial Master File/Investigator Site File records.

• Act as the primary MapLight contact for Investigator sites.

• Facilitate protocol compliance, communication, site staff needs, and training requirements.

• Aid in inspections and audits.

• Assist in the development of study documents and procedures.

• Support the creation of monitoring plans, templates, and tools.

• Help with the setup, testing, and maintenance of study systems such as EDC, eCOA, and IRT.

• Reconcile Trial Master File and Investigator Site File records to ensure inspection readiness.

• Stay informed about regulatory requirements and monitoring best practices.

• Contribute to improving monitoring functions and processes.

• Assist in the development and revision of SOPs, processes, templates, tools, and plans.

• Participate in the maintenance and efficiency improvements of clinical systems.

• Collaborate with Clinical Operations, Medical Monitoring, Data Management, Supply Chain, Clinical Compliance and Quality, CROs, and vendors.

⛳️ Requirements

• A minimum of 5 years in the clinical trial industry with at least 4 years of clinical monitoring experience, covering complex therapeutic areas, inpatient trials, and blinded trials.

• Experience in CNS and/or neuropsychiatry, particularly with in-patient schizophrenia and/or Alzheimer’s disease psychosis or agitation is highly preferred.

• Background in small/emerging biotech is advantageous.

• Proven experience managing multiple Investigator sites and studies concurrently.

• Willingness to travel nationally to assigned Investigator sites as necessary for required visits.

• Strong understanding of Good Clinical Practices (GCPs), ALCOA+, and relevant regulations.

• Capability to engage collaboratively with internal and external stakeholders in a professional manner.

• Excellent interpersonal, oral, and written communication skills.

• Self-motivated individual who can work independently and proactively.

• Team-oriented with a readiness to take on additional responsibilities as needed.

• Fundamental knowledge of medical terminology and clinical trial processes related to executing a clinical development plan.

• Exceptional attention to detail and a strong focus on quality and compliance.

• Experience with clinical software systems such as EDC, CTMS, eTMF, eCOA, and EMR.

• Proficiency in Microsoft Office applications: Word, Excel, PowerPoint, and Outlook.

• Ability to travel independently by air, car, and/or train; proximity to a major airport is preferred.

• Capability to work remotely from the Texas or Arizona area.

🏝️ Benefits

• Annual bonus opportunity.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• Life insurance.

• AD&D insurance.

• Short-term disability.

• Long-term disability.

• 401(K) plan with matching contributions.

• Stock options.

• Flexible non-accrual paid time off.

• Parental leave.