Apply on Employer Site

MapLight Therapeutics, Inc. · 11 hours ago

Senior Clinical Research Associate (CRA) - Texas

Texas

Full-time

Hybrid

Senior Level

$135K/yr - $150K/yr

5+ years exp

MapLight Therapeutics is a clinical stage biotech company focused on drug discovery for central nervous system disorders. The Senior Clinical Research Associate will manage Investigator sites, ensuring compliance with regulatory standards and quality oversight throughout the clinical trial process.

BiopharmaBiotechnologyLife ScienceMedical

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

Qualification

Clinical monitoring experienceClinical Practices (GCP)CNS/neuropsychiatry experienceClinical software systemsInterpersonal communicationMedical terminology knowledgeMicrosoft Office proficiencyAttention to detailTeam playerSelf-starter

Required

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

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

Preferred

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

Location near a major airport preferred

Benefits

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

Parental leave

Company

MapLight Therapeutics, Inc.

Maplight is a biopharmaceutical company discovering and developing novel therapeutics for patients with disorders of the central nervous system (CNS).

Founded in 2018

Palo Alto, California, USA

51-200 employees