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Clinical Research Associate II
2 months ago
MapLight Therapeutics, Inc. is seeking a highly skilled Clinical Research Associate II to join our team in the Southern California region. As a key member of our clinical operations team, you will be responsible for ensuring the quality and compliance of our clinical trials in the central nervous system (CNS) therapeutic area.
Key Responsibilities- 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.
- Support the study team in meeting study milestones, including site activation, DSMB meetings, database lock, and other key events.
- Perform centralized monitoring activities between on-site visits to ensure timely resolution of action items, oversight of study data quality and flow, and proactive identification and mitigation of 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, and other relevant documents.
- 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 requirements.
- Support the study team and Investigator sites during inspections or audits, as needed.
- Perform other assigned tasks, as requested.
- Support the study team in the development of study documents and procedures.
- 4+ years of experience in the clinical trial industry, with at least 3 years of clinical monitoring experience, including complex therapeutic areas, in-patient trials, and blinded trials.
- Recent CNS and/or neuropsychiatry experience, specifically in-patient schizophrenia and Alzheimer's disease psychosis, is strongly preferred.
- 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, including EDC, CTMS, eTMF, eCOA, and EMR.
- Proficiency with Microsoft Office applications, including Word, Excel, PowerPoint, and Outlook.
- Ability to travel independently by air, car, and/or train, with a preference for locations near major airports.
This role will require up to 75% travel, with potential to be higher during peak activity periods. Every effort will be made to keep travel regional, but travel outside of the region may be required on occasion. Additional periodic travel for meetings is also expected.
Compensation and BenefitsThe estimated salary for this role at MapLight ranges from $112,000 to $150,000. Actual compensation packages are based on several factors, including but not limited to, skill set, depth of experience, certifications, and work location. MapLight's compensation package also includes equity and an annual target bonus for full-time positions. In addition, MapLight offers a wide range of best-in-class employee benefits, including healthcare, dental, vision, a 401(k) plan, and paid time off.
About MapLight Therapeutics, Inc.MapLight Therapeutics, Inc. is a clinical stage biotech company focused on drug discovery for central nervous system disorders. We combine cutting-edge technologies, including optogenetics, in vivo physiology, and spatial transcriptomics, to identify novel drug targets and develop effective therapies to address psychiatric symptoms.
