Senior Clinical Research Associate (CRA)

Remote

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, Clinical ResearchIndustries

Requirements

The Senior Clinical Research Associate should have 4-6 years of experience in the clinical trial industry, with at least 3 years of clinical monitoring experience in complex therapeutic areas, in-patient trials, and blinded trials. Experience in CNS and/or neuropsychiatry, particularly with in-patient schizophrenia, Alzheimer's disease psychosis, or Alzheimer's disease agitation, is strongly preferred. A strong understanding of ICH GCP guidelines and quality/regulatory best practices is also required.

Responsibilities

The Senior CRA will perform quality and compliant investigator site monitoring and management, including conducting pre-study, initiation, interim, and closeout visits. They will perform both on-site and centralized monitoring activities to ensure subject safety, data integrity, and risk management. This role involves collaborating with internal stakeholders and external partners, maintaining accurate documentation, serving as the primary contact for investigator sites, supporting audits and inspections, and contributing to the development of study documents, monitoring plans, and SOPs.

Skills

Investigator site monitoring

Investigator site management

ICH GCP

Centralized monitoring

Risk management

Clinical Operations

Data Management

CNS disorders

Neuropsychiatry

Schizophrenia

Alzheimer's disease psychosis

Alzheimer's disease agitation

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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