Clinical Trials Coordinator: Patient‑Focused & Compliant
Medix™
60K–80K a year
Behavioral Health Market Context
Apply Nowvia Learn4Good
Job Description
patient safety, data integrity, and protocol adherence.
• Study Initiation & Planning: Assist with site feasibility assessments, attend investigator meetings, and prepare the Investigator Site File (ISF).
• Subject Recruitment & Screening: Identify, screen, and recruit study participants based on inclusion/exclusion criteria.
• Informed Consent Process: Obtain informed consent from subjects under the guidance of the PI, ensuring they understand the study procedures, risks, and benefits.
• Study Visits & Procedures: Schedule and conduct study visits, perform study-specific procedures (e.g., vital signs, ECGs, blood draws) as per protocol.
• Data Collection & Management: Accurately collect and enter patient data into Electronic Data Capture (EDC) systems, ensuring source document accuracy and resolution of queries in a timely manner.
• Regulatory Compliance: Maintain regulatory binders, submit documents to the IRB (initials, amendments, renewals), and report Adverse Events (AEs) and Serious Adverse Events (SAEs).
• Investigational Product (IP) Management: Oversee the receipt, storage, dispensing, and accountability of investigational products.
• Lab Management: Process, store, and ship laboratory specimens according to protocol requirements.
• Liaison Duties: Act as the main contact for sponsors, Clinical Research Associates (CRAs), and vendors during monitoring visits and audits.
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• Study Initiation & Planning: Assist with site feasibility assessments, attend investigator meetings, and prepare the Investigator Site File (ISF).
• Subject Recruitment & Screening: Identify, screen, and recruit study participants based on inclusion/exclusion criteria.
• Informed Consent Process: Obtain informed consent from subjects under the guidance of the PI, ensuring they understand the study procedures, risks, and benefits.
• Study Visits & Procedures: Schedule and conduct study visits, perform study-specific procedures (e.g., vital signs, ECGs, blood draws) as per protocol.
• Data Collection & Management: Accurately collect and enter patient data into Electronic Data Capture (EDC) systems, ensuring source document accuracy and resolution of queries in a timely manner.
• Regulatory Compliance: Maintain regulatory binders, submit documents to the IRB (initials, amendments, renewals), and report Adverse Events (AEs) and Serious Adverse Events (SAEs).
• Investigational Product (IP) Management: Oversee the receipt, storage, dispensing, and accountability of investigational products.
• Lab Management: Process, store, and ship laboratory specimens according to protocol requirements.
• Liaison Duties: Act as the main contact for sponsors, Clinical Research Associates (CRAs), and vendors during monitoring visits and audits.
#J-18808-Ljbffr
Qualifications
Benefits
Responsibilities
- •The CRC acts as the primary liaison between the PI, study subjects, sponsors, and the Institutional Review Board (IRB), with a primary focus on patient safety, data integrity, and protocol adherence
- •Study Initiation & Planning: Assist with site feasibility assessments, attend investigator meetings, and prepare the Investigator Site File (ISF)
- •Subject Recruitment & Screening: Identify, screen, and recruit study participants based on inclusion/exclusion criteria
- •Informed Consent Process: Obtain informed consent from subjects under the guidance of the PI, ensuring they understand the study procedures, risks, and benefits
- •Study Visits & Procedures: Schedule and conduct study visits, perform study-specific procedures (e.g., vital signs, ECGs, blood draws) as per protocol
- •Data Collection & Management: Accurately collect and enter patient data into Electronic Data Capture (EDC) systems, ensuring source document accuracy and resolution of queries in a timely manner
- •Regulatory Compliance: Maintain regulatory binders, submit documents to the IRB (initials, amendments, renewals), and report Adverse Events (AEs) and Serious Adverse Events (SAEs)
- •Investigational Product (IP) Management: Oversee the receipt, storage, dispensing, and accountability of investigational products
- •Lab Management: Process, store, and ship laboratory specimens according to protocol requirements
- •Liaison Duties: Act as the main contact for sponsors, Clinical Research Associates (CRAs), and vendors during monitoring visits and audits
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