Sub-Investigator; APRN

Overview
The Sub-Investigator (APRN) supports the Principal Investigator (PI) in the safe, ethical, and compliant conduct of clinical research studies. The APRN will provide clinical assessment, participant care, and medical oversight as delegated by the PI and in accordance with the study protocol, Good Clinical Practice (GCP), applicable regulations, and site Standard Operating Procedures (SOPs).

The Sub-Investigator will work closely with the Principal Investigator, Clinical Research Coordinators, study staff, sponsors, CROs, and other healthcare professionals to ensure participant safety and the accurate and timely completion of study-related activities.

• Assist the Principal Investigator with medical and clinical oversight of assigned clinical research studies.
• Perform and document physical examinations, medical histories, and protocol-required clinical assessments.
• Evaluate participants for eligibility and assist with confirmation of inclusion/exclusion criteria as delegated by the PI.
• Participate in screening, baseline, treatment, follow-up, and unscheduled study visits.
• Assess, document, and report adverse events (AEs) and serious adverse events (SAEs) in accordance with the protocol and applicable requirements.
• Review laboratory, diagnostic, and other clinical results as appropriate.
• Evaluate participant response to investigational treatment and document clinical outcomes.
• Review concomitant medications and medical history for clinical relevance and protocol compliance.
• Communicate clinically significant findings to the Principal Investigator in a timely manner.
• Assist the PI with clinical decision-making related to participant safety and study eligibility.
• Perform protocol-required clinical procedures within the APRN's scope of practice and site delegation.
• Ensure study-related clinical documentation is accurate, complete, and timely.
• Review and sign study documents and source records when appropriately delegated.
• Assist with resolution of clinical data queries and discrepancies.
• Maintain knowledge of study protocols, Investigator's Brochures, study procedures, and applicable regulatory requirements.
• Participate in investigator meetings, site initiation visits, monitoring visits, audits, and inspections as required.
• Maintain compliance with ICH-GCP, FDA regulations, IRB requirements, and site SOPs.
• Protect participant rights, safety, privacy, and confidentiality throughout the study.
• Assist with subject recruitment and screening activities in accordance with the study protocol and applicable regulations.

• Collaborative healthcare office environment

• Regular use of computer systems and documentation review

Work Location:

In person

This description indicates, in general terms, the type and level of work performed and responsibilities held by the team member(s). Duties described are not to be interpreted as being all-inclusive or specific to any individual team member.

Our company is committed to creating a diverse environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. DFWP