In-House Clinical Research Associate - Data-Driven & Collaborative

Alira Health; Framingham (MA); On-site; USD 50,000 - 70,000; Full time

Job summary

Alira Health is seeking an In-house Clinical Research Associate (CRA) to support clinical sites from approval through close-out, with limited travel. You will collaborate with field CRAs and PMs to maintain data integrity and regulatory compliance in a fast-paced environment.

The role requires 1-2 years in clinical research, a BA/BS, and strong English communication, with proficiency in MS Office. Regular responsibilities include preparing study documents, coordinating IRB submissions, and

Qualifications

• BS/BA from an undergraduate program or equivalent experience.
• 1-2 years of experience in clinical research.

Responsibilities

• Develops study documents and tools, including ICF templates for local and central IRBs.
• Supports sites in obtaining IRB approval and developing submission materials.
• Responds to sites' regulatory requests for protocol and ICF clarification.
• Ensures regulatory documents are in place before investigational product shipment.
• Keeps TMF up-to-date and conducts routine file reviews.
• Analyzes site performance and provides training for study sites.
• Maintains communication with sites to ensure protocol/GCP compliance.
• Reviews data remotely on eCRFs and resolves data queries.
• Aids in recruiting investigative sites for studies.
• Complies with ICH GCP, FDA regulations, and SOPs.
• Participates in internal and sponsor meetings.
• Manages conflicting priorities; performs additional duties.

Skills

Detail-oriented

Organizational skills

Analytical

Leadership

Communication

Problem-solving

Cross-functional teamwork

Self-starter

English proficiency

Education

Bachelor's degree (BA/BS)

Tools

MS Office

Job description

Alira Health is seeking an In-house Clinical Research Associate (CRA) to support clinical sites from approval through close-out, with limited travel. You will collaborate with field CRAs and PMs to maintain data integrity and regulatory compliance in a fast-paced environment.

The role requires 1-2 years in clinical research, a BA/BS, and strong English communication, with proficiency in MS Office. Regular responsibilities include preparing study documents, coordinating IRB submissions, and