Senior Clinical Research Associate (CRA) - South California at Abata Therapeutics

California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, Clinical ResearchIndustries

Requirements

Approximately 5+ 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 experience, specifically in-patient schizophrenia and/or Alzheimer’s disease psychosis or Alzheimer's disease agitation (strongly preferred)

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

Skills

Key technologies and capabilities for this role

ICH GCPClinical MonitoringSite ManagementCentralized MonitoringRisk ManagementRegulatory ComplianceClinical OperationsData ManagementSchizophreniaAlzheimer's DiseasePsychiatryDSMBSOPs

Questions & Answers

Common questions about this position

What experience is strongly preferred for this Senior CRA role?

CNS and/or neuropsychiatry experience, specifically in-patient schizophrenia and/or Alzheimer’s disease psychosis or Alzheimer's disease agitation, is strongly preferred.

What are the main responsibilities of the Senior CRA?

The role involves performing quality and compliant Investigator site monitoring and management, conducting on-site and centralized monitoring visits, maintaining site relationships, ensuring data integrity and subject safety, and collaborating with cross-functional teams and external partners.

Is this Senior CRA position remote or based in South California?

This information is not specified in the job description.

What is the salary or compensation for this role?

This information is not specified in the job description.

Who does the Senior CRA report to and collaborate with?

The Senior CRA reports to the Lead Clinical Research Associate and collaborates closely with 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.

Abata Therapeutics

Develops therapies for autoimmune diseases

About Abata Therapeutics

Abata Therapeutics develops therapies for autoimmune diseases, focusing on type 1 diabetes. Their main product, ABA 201, is a Treg cell therapy aimed at patients with some remaining beta cell function. This therapy works by utilizing regulatory T cells to improve patient outcomes. Unlike many competitors, Abata targets a specific niche within the autoimmune disease market and collaborates with partners like ElevateBio for process development and manufacturing. The company's goal is to transform treatment options for autoimmune diseases through advanced research and development.

Cambridge, MassachusettsHeadquarters

2021Year Founded

$184.8MTotal Funding

EARLY_VCCompany Stage

BiotechnologyIndustries

11-50Employees

Risks

Intensifying competition from companies like Sangamo Therapeutics may impact Abata's market share.

Stringent FDA scrutiny on manufacturing could delay Abata's clinical trials.

Rising clinical trial costs pose financial risks to Abata's pipeline progression.

Differentiation

Abata focuses on Treg cell therapies for autoimmune diseases like MS and diabetes.

Their lead product, ABA 201, targets type 1 diabetes with remaining beta cell function.

Abata's strategic partnership with ElevateBio enhances their manufacturing capabilities.

Upsides

Recent investment from Bristol Myers Squibb boosts Abata's Treg therapy pipeline development.

FDA's accelerated approval pathways may expedite Abata's clinical trials.

Growing autoimmune disease prevalence increases demand for Abata's innovative treatments.

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