Sub-Investigator

Be Well Clinical Studies•Lincoln, NE

3d•$65 - $90•Onsite

About The Position

The Sub-Investigator (Sub-I) supports the Principal Investigator (PI) in the safe and compliant conduct of clinical trials. This role is responsible for performing study-related medical procedures, ensuring protocol adherence, protecting subject safety, and maintaining high standards of data integrity in accordance with Good Clinical Practice (GCP), FDA regulations, and study-specific requirements. The Sub-I plays a critical role and must be able to independently assess subjects, make medical decisions, and support clinical conduct of study execution in collaboration with the PI and clinical operations team.

Requirements

MD, DO, NP, or PA with active, unrestricted license in applicable state(s)
Current GCP certification (or willingness to complete training during onboarding)
DEA license (if applicable to study requirements)

Nice To Haves

Prior experience as an Investigator in clinical research strongly preferred
Strong understanding of GCP, FDA, and IRB regulations
Strong clinical judgment and ability to make independent medical decisions
High attention to detail with focus on data integrity and compliance
Ability to interpret clinical protocols and apply in real-world settings
Excellent communication and collaboration skills across multidisciplinary teams
Experience with eSource, EDC systems, and clinical trial documentation
Strong time management and ability to manage competing priorities

Responsibilities

Perform study-specific clinical assessments and evaluations (e.g., physical exams, medical history review, AE/SAE assessment)
Determine subject eligibility in accordance with protocol inclusion/exclusion criteria
Provide medical care and clinical assessment for enrolled subjects throughout study participation, as delegated by the PI
Review and sign off on clinical data, source documentation, and study-related assessments as delegated
Ensure subject safety, rights, and well-being are always prioritized
Maintain availability aligned with study scheduled, subject visits, and sponsor expectations
Perform all study activities in adherence to the Delegation of Authority Log (DOA), protocol, GCP guidelines, and FDA regulations
Maintain up-to-date knowledge of study protocols, IBs, and sponsor requirements
Support informed consent process, ensuring subjects understand risks, benefits, and study expectations
Review and assess adverse events (AEs) and serious adverse events (SAEs), ensuring appropriate documentation, escalation, and reporting timelines
Participate in audits, monitoring visits, and regulatory inspections
Collaborate with Clinical Operations, Recruitment, Coordinators, Quality Control, and Regulatory teams to ensure efficient and compliant study conduct
Ensure accuracy, completeness, and timeliness of source documentation, ensuring adherence to GCP and ALCOA-C principles
Review and resolve queries in collaboration with study coordinators and QC teams
Ensure that documentation meets audit-ready standards and aligns with BWCS SOPs