Onsite Clinical Research Coordinator - Data Compliance Pro

Actalent; New Jersey; On-site; USD 44,000 - 48,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Disability coverage

Health Spending Account

Transportation benefits

Employee Assistance Program

PTO / Vacation / Sick Leave

Job summary

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

You will coordinate with IRBs, principal investigators, and staff, manage source documents and forms, and ensure subject screening, consent, and trial documentation are properly maintained.

Qualifications

• 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 IRB applications.
• Act as liaison between IRB, principal investigators, and sub-investigators.
• Report all serious adverse events to sponsors and IRB.
• Serve as the primary study coordinator ensuring adherence to protocols.
• Assist in developing forms and questionnaires; maintain source documents.
• Create and maintain regulatory binders and files for protocols.
• Collaborate with research nurse coordinators on source documents.
• Screen subjects according to eligibility criteria.
• Obtain informed consent from participants.
• Maintain updated records and review active patient lists for protocol compliance.
• Perform periodic quality assurance audits for study documents.
• Oversee data collection, validation, and verification processes.

Skills

Clinical research experience

Education

Bachelor’s degree or equivalent

Mandatory education on human subject research

Job description

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

You will coordinate with IRBs, principal investigators, and staff, manage source documents and forms, and ensure subject screening, consent, and trial documentation are properly maintained.