Clinical Research Coordinator: IRB & Data Integrity Lead

Talentify; Edison (NJ); On-site; USD 44,000 - 48,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Disability insurance

Job summary

Actalent is seeking a dedicated Clinical Research Coordinator to join our team in Edison, NJ. You will assist in literature reviews, proposal development, and oversee various clinical research activities while ensuring compliance with regulatory mandates and data integrity.

Responsibilities include coordinating IRB submissions, acting as liaison among IRBs, PIs and sub-investigators, managing source documents, overseeing data collection and QA audits, and ensuring adherence to study protocols.

Qualifications

• Bachelor’s degree or equivalent required.
• Minimum of 3 years of clinical research experience.
• Mandatory education on human subject research.

Responsibilities

• Conduct literature reviews and collaborate on proposal development.
• Prepare and submit Institutional Review Board applications.
• Act as a liaison between IRB(s), principal investigators and sub-investigators.
• Oversee data collection, validation, and verification processes.
• Maintain regulatory binders and files for assigned protocols.
• Screen research subjects and obtain informed consent.

Skills

Clinical research experience

Regulatory compliance

IRB coordination

Education

Bachelor’s degree or equivalent

Job description

Actalent is seeking a dedicated Clinical Research Coordinator to join our team in Edison, NJ. You will assist in literature reviews, proposal development, and oversee various clinical research activities while ensuring compliance with regulatory mandates and data integrity.

Responsibilities include coordinating IRB submissions, acting as liaison among IRBs, PIs and sub-investigators, managing source documents, overseeing data collection and QA audits, and ensuring adherence to study protocols.