Position Summary
The Sub-Investigator, Physician is a licensed physician (MD or DO) who serves as a key member of the clinical research team, providing direct medical care and protocol-required clinical assessments on industry-sponsored clinical trials. The position is responsible for maintaining the highest standards of patient care and safety throughout the clinical trial process, including conducting physical examinations, interpreting laboratory results, overseeing patient health, and performing essential clinical procedures in collaboration with the research team.
The position operates in a Sub-Investigator capacity. Study-related activities are performed under the delegation and supervision of the Principal Investigator, who retains ultimate regulatory responsibility for study conduct in accordance with FDA regulations and ICH-GCP guidelines. The Sub-Investigator brings physician-level clinical judgment to eligibility evaluation, safety monitoring, and the assessment of clinical findings within that framework.
Delegation and Oversight
The position reports administratively to the Site Manager. For study conduct, the Sub-Investigator performs activities delegated by the Principal Investigator of each assigned study and works under that investigator's ongoing supervision in accordance with FDA regulations and ICH-GCP. The position does not hold ultimate regulatory responsibility for study conduct.
Essential Duties and Responsibilities
Clinical Care and Assessments
- Perform physical examinations and assess patients' medical histories in a clinical trial setting.
- Interpret and analyze laboratory results to monitor patient health and inform clinical decisions.
- Oversee and monitor patient health status throughout the trial, ensuring patient safety and compliance with protocol requirements.
- Administer medications and oversee the safe administration of investigational products, ensuring adherence to clinical protocols.
- Perform venipuncture and phlebotomy procedures for laboratory testing as required by study protocols.
- Prepare, initiate, and monitor IV infusions, including investigational product infusions, ensuring safe administration, accurate documentation, and appropriate patient monitoring.
- Conduct medical procedures such as IV line placement, injections, and other tasks as required by the study protocol.
- Monitor and provide safety observations during and after medication or infusion administration to ensure patient well-being and manage any adverse reactions.
Medical Judgment and Safety Oversight
- Support subject eligibility evaluation, treatment decisions, and clinical assessments within the scope delegated by the Principal Investigator.
- Assess adverse events and the clinical significance of findings, and escalate safety matters to the Principal Investigator for review and determination.
- Support the informed consent process, ensuring it is conducted appropriately and consistently.
- Participate in monitoring visits, audits, and regulatory inspections as required.
Collaboration and Documentation
- Collaborate with the Principal Investigator and other members of the clinical trial team to ensure effective execution of study protocols.
- Ensure proper documentation of clinical data in accordance with regulatory and ethical standards.
- Maintain a clear, open line of communication with other healthcare professionals to ensure integrated, patient-centered care.
- Participate in regular meetings and discussions to review patient progress, study outcomes, and other relevant clinical findings.
Patient Education and Engagement
- Educate patients and their families on the clinical trial process, including treatment plans and potential risks.
- Serve as a clinical resource to patients, staff, and referring providers, supporting awareness of and access to clinical research.
- Maintain current knowledge of developments in medical research and clinical practice.
Additional Responsibilities
This job description outlines the core duties of the Sub-Investigator, Physician; however, additional responsibilities may be assigned as needed to support the clinical trial and research efforts. These may include assisting in protocol design and feasibility review, supporting regulatory submissions, mentoring junior staff, and participating in educational and research initiatives.
Knowledge, Skills, and Abilities
- Sound clinical judgment and strong problem-solving skills, with the ability to apply medical decision-making within structured protocols.
- Demonstrated competency in phlebotomy and IV infusion, including patient monitoring during and after procedures.
- Excellent communication skills, with the ability to interact effectively with patients, families, and other healthcare professionals.
- Detail orientation with a commitment to accuracy in medical documentation and patient monitoring.
- Ability to work collaboratively within a multidisciplinary research team and under the supervision of a Principal Investigator.
- Commitment to patient advocacy and to advancing clinical knowledge and medical practice.
Required Licensure and Experience
Licensure and Certification
- MD or DO.
- Active, unrestricted medical license in the state of practice.
- Board certified or board eligible in a relevant specialty.
Experience
- Clinical practice experience with a focus on direct patient care.
- Strong understanding of, or willingness to be trained in, FDA regulations and ICH-GCP guidelines.
Preferred
- Prior experience in clinical trials or research settings, as a Sub-Investigator or Principal Investigator.
- Familiarity with regulatory guidelines and ethical practices in clinical research.
- Ability to educate patients and staff on clinical protocols and research procedures.
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