Principal Investigator

Company Description Andes Clinical Research is dedicated to serving and educating the community about access to clinical trials. The organization prioritizes inclusivity, working to ensure that study participants reflect the diversity of the populations who may benefit from new therapies. By generating reliable, high-quality data, Andes Clinical Research supports evidence-based decision-making for sponsors, clinicians, and patients. Team members contribute to research that aims to improve health outcomes while honoring the needs and voices of underrepresented groups. Joining Andes Clinical Research means helping advance clinical science in a way that represents everyone.
Role Description The Principal Investigator (PI) is responsible for the overall conduct, integrity, and quality of clinical trials at the Orem, UT site. This is an on-site contract role. The PI will oversee study design implementation at the site level, review and approve study protocols and informed consent forms, and ensure adherence to Good Clinical Practice (GCP), institutional policies, and regulatory requirements. Day-to-day responsibilities include evaluating and screening potential participants, obtaining and documenting informed consent, performing or supervising study-related medical assessments, and ensuring participant safety through ongoing clinical oversight. The PI will review and sign off on source documents and case report forms, manage protocol deviations, and communicate promptly with sponsors, CROs, IRBs, and internal staff. The role also involves leading and mentoring the clinical research team, attending site initiation and monitoring visits, and participating in audits and inspections as needed.
Qualifications

• Current, unrestricted medical license (MD or DO) in the state of Utah, with board certification or eligibility in a relevant specialty (e.g., internal medicine, family medicine, psychiatry, neurology, or other applicable field).
• Demonstrated experience as a Principal Investigator or Sub-Investigator in clinical research, with familiarity in Phase I–IV clinical trials and sponsor/CRO collaboration.
• Strong knowledge of Good Clinical Practice (GCP), ICH guidelines, FDA and other regulatory requirements, and institutional review board (IRB) processes.
• Proven ability to evaluate participants clinically, interpret laboratory and diagnostic results, and make sound medical decisions focused on participant safety.
• Effective leadership and team collaboration skills, with experience guiding coordinators, nurses, and support staff in a clinical research environment.
• Excellent written and verbal communication skills for documentation, reporting, and interaction with participants, sponsors, regulators, and internal stakeholders.
• High attention to detail, strong organizational skills, and the ability to manage multiple concurrent studies and timelines on site.
• Commitment to ethical research practices, inclusive participant recruitment, and culturally sensitive communication with diverse populations.
• Prior experience in community-based or outpatient research settings is preferred