Job Description
Job Description
Sub-Investigator
Key Responsibilities:
- Assist the Principal Investigator (PI) in overseeing and managing clinical trials conducted at the research site, ensuring adherence to the study protocol, Good Clinical Practice (GCP), ICH guidelines, and all applicable regulatory requirements.
- Provide medical oversight and ensure the safety and well-being of study participants throughout the trial, under the supervision of the PI.
- Perform delegated study-related duties as assigned by the PI, which may include comprehensive patient assessments, physical exams, medical histories, and eligibility screenings.
- Review and interpret eligibility, laboratory results, ECGs, and other diagnostic tests as required by the protocol and under PI supervision.
- Assist the PI in making medical decisions regarding participant care, adverse events, and protocol deviations.
- Ensure accurate, complete, and timely collection and documentation of all study data.
- Communicate effectively with the PI, study team, and, as delegated, with sponsors, Contract Research Organizations (CROs), Institutional Review Boards (IRBs), and regulatory authorities.
- Assist with investigational product accountability, storage, and administration according to protocol.
- Participate in site initiation visits, monitoring visits, audits, and inspections as required.
- Maintain continuous medical education and stay current with advancements in clinical research and relevant therapeutic areas.
Position Requirements:
- Master’s degree in Nursing from an accredited program.
- Current Nurse Practitioner certification (FNP, AGNP, or specialty certification) and state licensure.
- Experience (e.g., 1-3 years) in clinical research, either as a Sub-Investigator, research fellow, or similar role, with a strong understanding of clinical trial processes.
- Demonstrated knowledge of ICH-GCP guidelines, FDA regulations, and other relevant ethical and regulatory requirements for clinical research.
- Strong interpersonal and communication skills, with the ability to work effectively as part of a team.
- Excellent clinical judgment and problem-solving abilities.
- Meticulous attention to detail and strong organizational skills.
- Ability to prioritize tasks and manage time efficiently.
- Familiarity with clinical trial management systems (CTMS) and electronic data capture (EDC) systems is a plus.
- Commitment to ethical conduct and patient safety.
Location:
This position requires NP travel to the location of the study/program participant/patient. Travel may be local or across state lines based on licensure to practice.