Senior Clinical Research Associate - Florida

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

📋 Description

• Execute quality and compliant monitoring of Investigator sites while fostering strong relationships in accordance with MapLight SOPs, ICH GCP, and regulatory best practices.

• Conduct both on-site and centralized monitoring to guarantee subject safety, data integrity, proactive risk management, and readiness for inspections.

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

• Manage assigned Investigator sites and sustain positive relationships with them.

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

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

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

• Maintain compliant documentation for monitoring, reports, Trial Master Files, and Investigator Site Files.

• Act as MapLight’s primary liaison for Investigator sites regarding protocol compliance, communication, responses, and training.

• Assist with inspections and audits.

• Aid in the development of study documents, procedures, monitoring plans, templates, tools, and clinical systems.

• Support the setup, testing, and maintenance of EDC, eCOA, IRT, and associated study documents.

• Review and reconcile Trial Master Files and Investigator Site Files to ensure inspection readiness.

• Maintain up-to-date knowledge of monitoring regulations and best practices for risk-based monitoring.

• Contribute to improvements in monitoring processes and SOP development.

• Participate in enhancing clinical systems for better efficiency.

⛳️ Requirements

• A minimum of 5 years in the clinical trial sector, with at least 4 years specifically in clinical monitoring, including experience in complex therapeutic areas, in-patient trials, and blinded trials.

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

• Ideal candidates will have experience working within small or emerging biotech firms.

• Proven ability to manage multiple Investigator sites and studies simultaneously.

• Willingness to travel nationally to assigned Investigator sites as necessary.

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

• Capacity to collaborate effectively with both internal and external stakeholders.

• Excellent interpersonal, oral, and written communication skills.

• Ability to work independently and take initiative proactively.

• Openness to accept additional responsibilities as needed.

• Familiarity with medical terminology and activities related to the execution of a clinical development plan.

• High attention to detail, emphasizing 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.

• Capability to travel independently by air, car, and/or train.

• Proximity to a major airport is preferred.

🏝️ 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 match.

• Stock options.

• Flexible non-accrual paid time off.

• Parental leave.