Clinical Research Coordinator 251768
Behavioral Health Market Context
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Job Description
s, sponsors, and the Institutional Review Board (IRB) to ensure participant safety and data integrity.
Key Responsibilities
• Study Startup & Regulatory: Assist with protocol review, IRB submissions, and preparation of regulatory binders.
• Participant Recruitment & Screening: Identify, recruit, and screen potential participants against inclusion/exclusion criteria.
• Informed Consent: Conduct the informed consent process, ensuring participants understand study requirements, risks, and benefits.
• Study Visits & Procedures: Coordinate and conduct study visits, perform study procedures (e.g., ECGs, vitals), and manage participant follow-up.
• Data Management: Collect, record, and enter accurate source data into Electronic Data Capture (EDC) systems in a timely manner; resolve queries.
• Specimen Management: Collect, process, label, store, and ship laboratory specimens according to the protocol and IATA regulations.
• Safety & Compliance: Monitor participant safety, record adverse events (AEs), and report serious adverse events (SAEs) promptly to the PI and sponsor.
• Investigational Product (IP): Oversee proper receipt, storage, dispensing, and accountability of study drugs/devices.
• Site Visits: Host sponsor monitoring visits
Key Responsibilities
• Study Startup & Regulatory: Assist with protocol review, IRB submissions, and preparation of regulatory binders.
• Participant Recruitment & Screening: Identify, recruit, and screen potential participants against inclusion/exclusion criteria.
• Informed Consent: Conduct the informed consent process, ensuring participants understand study requirements, risks, and benefits.
• Study Visits & Procedures: Coordinate and conduct study visits, perform study procedures (e.g., ECGs, vitals), and manage participant follow-up.
• Data Management: Collect, record, and enter accurate source data into Electronic Data Capture (EDC) systems in a timely manner; resolve queries.
• Specimen Management: Collect, process, label, store, and ship laboratory specimens according to the protocol and IATA regulations.
• Safety & Compliance: Monitor participant safety, record adverse events (AEs), and report serious adverse events (SAEs) promptly to the PI and sponsor.
• Investigational Product (IP): Oversee proper receipt, storage, dispensing, and accountability of study drugs/devices.
• Site Visits: Host sponsor monitoring visits
Qualifications
Benefits
Responsibilities
- •The Clinical Research Coordinator (CRC) is responsible for the daily management and execution of clinical trials at the research site, working under the guidance of the Principal Investigator (PI)
- •The CRC ensures that studies are conducted in accordance with the study protocol, ICH-GCP guidelines, FDA regulations, and institutional SOPs
- •Study Startup & Regulatory: Assist with protocol review, IRB submissions, and preparation of regulatory binders
- •Participant Recruitment & Screening: Identify, recruit, and screen potential participants against inclusion/exclusion criteria
- •Informed Consent: Conduct the informed consent process, ensuring participants understand study requirements, risks, and benefits
- •Study Visits & Procedures: Coordinate and conduct study visits, perform study procedures (e.g., ECGs, vitals), and manage participant follow-up
- •Data Management: Collect, record, and enter accurate source data into Electronic Data Capture (EDC) systems in a timely manner; resolve queries
- •Specimen Management: Collect, process, label, store, and ship laboratory specimens according to the protocol and IATA regulations
- •Safety & Compliance: Monitor participant safety, record adverse events (AEs), and report serious adverse events (SAEs) promptly to the PI and sponsor
- •Investigational Product (IP): Oversee proper receipt, storage, dispensing, and accountability of study drugs/devices
- •Site Visits: Host sponsor monitoring visits
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