- 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.
- As requested:
- 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.
- 4+ 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. (Recent CNS and/or neuropsychiatry, specifically in-patient schizophrenia and Alzheimer's disease psychosis 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.
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Clinical Research Associate II - Burlington, United States - MapLight Therapeutics, Inc.
Description
Who We Are: MapLight Therapeutics is a clinical stage biotech company that focuses 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.
What You'll Do: Reporting to the Lead Clinical Research Associate, the CRA II/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.
The title of CRA II or Sr. CRA, as well as compensation upon offer of employment, will be commensurate with experience and qualifications.
Responsibilities:
Qualifications:
Travel: Position will require up to 75% travel with potential to be higher at times of peak activity. Every effort will be made to keep travel regional but travel outside of a region may be required on occasion. Additional periodic travel for meetings is also expected.
Salary: The estimated salary for this role at MapLight ranges from $112,000 to $150,000. Actual compensation packages are based on several factors that are unique to each candidate, 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 fulltime 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.
MapLight is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
