Job Description

We are currently searching for an experienced physician to work full time (Mon - Fri) Onsite in Watertown MA as a sub Investigator on our industry sponsored clinical research trials. We are open to a variety of backgrounds including: Sleep Disorders, Psychiatry, Neurology, Anesthesiology, Emergency Medicine, and Internal Medicine.

The ideal candidate will also be able to read EKG's.

Previous clinical research experience is not required.

Sub Investigators play a crucial role in supporting the Principal Investigator (PI) to ensure the study is conducted according to the protocol, Good Clinical Practice (GCP), and regulatory requirements. Below are the standard responsibilities of a Sub-Investigator:

🔹 Clinical Oversight

• Conduct study-related procedures delegated by the PI (e.g., physical exams, medical assessments, reviewing labs).
• Ensure participant safety and evaluate adverse events.
• Assist in determining participant eligibility and informed consent process.

🔹 Protocol Adherence

• Understand and follow the study protocol and amendments.
• Report protocol deviations promptly to the PI and study sponsor.

🔹 Documentation & Data Integrity

• Accurately complete source documents and case report forms (CRFs).
• Review and verify data entered into the electronic data capture (EDC) system.
• Maintain accurate and timely medical records.

🔹 Regulatory & Compliance

• Comply with ICH-GCP guidelines, FDA regulations, and institutional SOPs.
• Participate in site monitoring visits, audits, and inspections as needed.
• Report adverse events (AEs) and serious adverse events (SAEs) in accordance with regulatory timelines.

🔹 Patient Interaction

• Provide direct clinical care to study participants.
• Educate participants about the study, investigational product, procedures, and potential risks/benefits.
• Ensure participants’ rights, safety, and well-being are protected throughout the study.

🔹 Collaboration with Study Team

• Work closely with the PI, study coordinators, and sponsor representatives.
• Attend investigator meetings, site initiation visits, and protocol training sessions when required.

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