MapLight Therapeutics is a clinical stage biotech company focused on drug discovery for central nervous system disorders, aiming to identify novel drug targets and develop effective therapies for psychiatric symptoms using advanced technologies.
Requirements
- Experience working in various clinical software systems (EDC, CTMS, eTMF, eCOA, EMR).
- Proficiency with Microsoft Office applications (Word, Excel, PowerPoint, Outlook).
- Strong working knowledge of Good Clinical Practices (GCPs), ALCOA+, and pertinent regulations.
- Approximately 4-6 years in the clinical trial industry with at least 3 years of clinical monitoring experience including complex therapeutic areas, in-patient trials, and blinded trials.
- Experience managing multiple Investigator sites and multiple studies simultaneously.
- 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.
Responsibilities
- Perform on-site monitoring and centralized monitoring to ensure subject safety, the highest data integrity, and contribute to proactive risk management and inspection readiness.
- 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.
- Support the study team and Investigator sites during inspections or audits, as needed.
- 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.
- Contribute to the maintenance and improvement of clinical systems to drive process improvement and efficiency.
Other
- Effectively manage assigned Investigator sites and maintain positive relationships with site personnel.
- 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.
- Embody and demonstrate MapLight’s core values of Integrity, Collaboration, Bravery, and Dedication.
- 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.
