Senior Clinical Research Associate (CRA) - Texas or Arizona at MapLight Therapeutics in Texas/Arizona Region

Job description

• What You’ll Do: The Sr. CRA will perform quality and compliant Investigator site monitoring and relationship-driven Investigator site management in line with MapLight’s SOPs, our Mission, Vision, and Values, as well as industry quality and regulatory best practices (ICH GCP). The CRA will perform on-site monitoring and centralized monitoring to ensure subject safety, the highest data integrity, and contribute to proactive risk management and inspection readiness.
• This role will collaborate closely with key cross-functional internal stakeholders including Clinical Operations, Medical Monitoring, Data Management, Supply Chain, and Clinical Compliance and Quality as well as external CRO and vendor partners to ensure quality study oversight from study start up through close out.

Responsibilities

• Effectively manage assigned Investigator sites and maintain positive relationships with site personnel.
• Prepare for and conduct Pre-Study, Initiation, Interim and Closeout monitoring visits in accordance with MapLight SOPs and procedures, regulatory requirements and industry guidelines and best practices (ICH GCP).
• Support the study team in meeting study milestones (site activation, DSMB meetings, database lock, etc.).
• Perform centralized monitoring activities between on-site visits to ensure timely resolution of action items, oversight of study data quality and flow, and proactively identify and mitigate/manage study risks and issues.
• Maintain quality and compliant documentation related to all aspects of site management including quality and ALCOA+ compliant monitoring visit reports, centralized monitoring reports, site contact reports, Trial Master File/Investigator Site File, etc.
• Serve as the main MapLight point of contact for Investigator sites to support protocol compliance, streamlined communications, timely responses to site staff needs, and training needs.
• Support the study team and Investigator sites during inspections or audits, as needed.
• Perform other assigned tasks, as requested.
• Support the study team(s) in development of study documents and procedures.
• Support the development and maintenance of the study monitoring plan, templates, and tools.
• Support the set-up, testing, and maintenance of study systems (EDC, eCOA, IRT, etc.) as well as related supporting documents (manuals, eCRF Completion Guidelines, etc.) in collaboration with MapLight and CRO/vendor study team members.
• Continually review and reconcile the Trial Master File and Investigator Site File for assigned sites to ensure inspection readiness.
• Maintain current knowledge of regulatory requirements and industry best practices related to monitoring, including centralized monitoring and risk-based monitoring.
• Support development and process improvement for the MapLight monitoring function.
• Support development and revision of SOPs, processes, templates, tools, and plans with the aim of continual improvement and streamlining.
• Contribute to the maintenance and improvement of clinical systems to drive process improvement and efficiency.
• Embody and demonstrate MapLight’s core values of Integrity, Collaboration, Bravery, and Dedication.

Requirements

• Approximately 5 plus years in the clinical trial industry with at least 4 years of clinical monitoring experience including complex therapeutic areas, in-patient trials, and blinded trials.
• CNS and/or neuropsychiatry, specifically in-patient schizophrenia and/or Alzheimer’s disease psychosis or Alzheimer's disease agitation experience strongly preferred.
• Experience working in small/emerging biotech is ideal
• Experience managing multiple Investigator sites and multiple studies simultaneously.
• Willingness to travel nationally to assigned Investigator sites as needed for required visits.
• Ability to build relationships between Investigator sites and MapLight to foster strong collaboration, trust, and positive working relationships.
• Strong working knowledge of Good Clinical Practices (GCPs), ALCOA+, and pertinent regulations.
• Ability to engage collaboratively with internal and external stakeholders in a professional manner.
• Strong interpersonal, oral, and written communication skills.
• A self-starter with the ability to work independently and proactively.
• Willingness to be a “team player” and take on additional responsibilities as requested.
• Demonstrates core understanding of medical terminology and clinical trial activities in relation to execution of a clinical development plan.
• High attention to detail and focus on quality and compliance in all aspects of assigned work.
• Experience working in various clinical software systems (EDC, CTMS, eTMF, eCOA, EMR).
• Proficiency with Microsoft Office applications (Word, Excel, PowerPoint, Outlook).
• Ability to travel independently by air, car and/or train. Location near a major airport preferred.
• CNS and/or neuropsychiatry, specifically in-patient schizophrenia and/or Alzheimer’s disease psychosis or Alzheimer's disease agitation experience strongly preferred.

Skills

Required

• Clinical monitoring
• Good Clinical Practices (GCPs)
• ALCOA+
• Regulatory knowledge
• Site management
• Communication skills
• Interpersonal skills
• Self-starter
• Team player
• Medical terminology
• Attention to detail
• Travel by air, car, train

Preferred

• CNS and/or neuropsychiatry experience
• Small/emerging biotech experience

Benefits

• Compensation for this role may vary within the above range based on many factors including geographic location, candidate experience, and skills. Additional compensation/benefits include annual bonus opportunity, medical, dental, vision, life and AD&D, short term and long term disability, 401(K) plan with match, stock options, flexible non-accrual paid time off, and parental leave.
• $145,000 - $160,000 USD