Job Description

Job Description

Job Title: Sub-Investigator (Clinical Research)

Job Summary:

The Sub-Investigator (Sub-I) supports the Principal Investigator (PI) in the planning, conduct, and oversight of clinical trials. They ensure the study is conducted according to the protocol, GCP (Good Clinical Practice), and applicable regulatory requirements, ensuring participant safety and data integrity.

Key Responsibilities:

• Assist the Principal Investigator in all aspects of the clinical trial.
• Conduct study visits and clinical assessments according to the study protocol.
• Obtain informed consent from study participants (if delegated).
• Evaluate and report adverse events, serious adverse events, and other safety information.
• Review and interpret clinical data (labs, ECGs, vital signs, etc.).
• Ensure compliance with study protocol, SOPs, ICH-GCP guidelines, and regulatory requirements.
• Collaborate with the study team including CRCs, monitors, sponsors, and IRBs.
• Document study activities accurately and in a timely manner in source documents and CRFs.
• Maintain patient confidentiality and data security at all times.
• Attend investigator meetings and training sessions as required.
• Assist with regulatory submissions and audit readiness.

Qualifications:

• Relevant clinical background (e.g., RN, PA, NP).
• Clinical experience in a hospital, research, or pharmaceutical setting.
• Familiarity with ICH-GCP and clinical trial processes.
• Strong attention to detail and organizational skills.
• Excellent communication and teamwork abilities.

Preferred Skills:

• Previous experience as a sub-investigator or clinical trial practitioner.
• Knowledge of therapeutic area(s) relevant to the study.
• Experience with electronic data capture (EDC) systems.

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