MapLight Therapeutics is looking to solve the problem of drug discovery for central nervous system disorders by identifying novel drug targets and developing effective therapies to address psychiatric symptoms.
Requirements
- Strong working knowledge of Good Clinical Practices (GCPs), ALCOA+, and pertinent regulations.
- Experience working in various clinical software systems (EDC, CTMS, eTMF, eCOA, EMR).
- Proficiency with Microsoft Office applications (Word, Excel, PowerPoint, Outlook).
- 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 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.
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).
- 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 in meeting study milestones (site activation, DSMB meetings, database lock, etc.).
- 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.
Other
- Ability to build relationships between Investigator sites and MapLight to foster strong collaboration, trust, and positive working relationships.
- 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 travel nationally to assigned Investigator sites as needed for required visits.
