Clinical Trial Sub Investigator
Ora
Summary
The Clinical Trial Sub Investigator is a full-time, on-site role based at ARENSIA's clinic in Phoenix, AZ. This role supports the Principal Investigator in the conduct of early-phase clinical trials, including performing protocol-specific medical assessments, documenting clinical findings, and ensuring adherence to study protocols and regulatory requirements.
Job description
Daily responsibilities include reviewing and assessing potential participants for eligibility, obtaining and documenting informed consent, overseeing study visits, and monitoring participant safety through continuous clinical evaluation. The Sub Investigator collaborates closely with the clinical and research staff to ensure accurate data collection, timely reporting of adverse events, and high-quality source documentation.
The role also involves participating in investigator meetings, maintaining up-to-date knowledge of study protocols and relevant therapeutic areas, and contributing to continuous improvement of site processes and patient experience.
Qualifications
- Clinical practice skills, including taking medical histories, performing focused physical examinations, and interpreting clinical data.
- Knowledge of Good Clinical Practice (GCP), ICH guidelines, and relevant FDA regulations, with the ability to apply these in daily trial conduct.
- Experience in conducting or supporting clinical trials, preferably in early-phase or exploratory medicine settings.
- Strong documentation and data review skills to ensure accurate source records, case report forms, and timely reporting of safety events.
- Effective communication and teamwork skills to collaborate with investigators, study coordinators, nurses, and external partners.
- Ability to manage multiple studies and patient visits, prioritize tasks, and maintain high attention to detail in a fast-paced environment.
- Professional degree (NP or PA) with an active, unrestricted license to practice in Arizona
- Prior experience in a research unit, hospital, or outpatient setting; experience with Phase I or Phase II trials is an advantage.
Requirements
- Clinical practice skills, including taking medical histories, performing focused physical examinations, and interpreting clinical data.
- Knowledge of Good Clinical Practice (GCP), ICH guidelines, and relevant FDA regulations, with the ability to apply these in daily trial conduct.
- Experience in conducting or supporting clinical trials, preferably in early-phase or exploratory medicine settings.
- Strong documentation and data review skills to ensure accurate source records, case report forms, and timely reporting of safety events.
- Effective communication and teamwork skills to collaborate with investigators, study coordinators, nurses, and external partners.
- Ability to manage multiple studies and patient visits, prioritize tasks, and maintain high attention to detail in a fast-paced environment.
- Professional degree (NP or PA) with an active, unrestricted license to practice in Arizona
- Prior experience in a research unit, hospital, or outpatient setting; experience with Phase I or Phase II trials is an advantage.
Company overview
Ora is the world's leading full-service ophthalmic drug and device development firm, operating as a specialized contract research organization (CRO) focused exclusively on ophthalmology. Founded in 1974 and headquartered in Andover, Massachusetts, the company has over 45 years of experience in advancing eye care innovations globally. Ora provides comprehensive research and development services spanning preclinical studies, clinical trials, regulatory strategy, and product development for both pharmaceutical and medical device companies. With operations across the United States, United Kingdom, Australia, and Asia, the company has helped clients achieve more than 85 product approvals to date. Ora's expertise covers a wide range of ophthalmic conditions including allergy, dry eye, retina diseases, glaucoma, and anti-infective therapies. The company employs over 500 ophthalmology specialists who utilize proprietary clinical models, integrated data solutions, and global regulatory strategies to accelerate product development from concept to market. Ora serves a diverse client base ranging from startups to global pharmaceutical and device companies, positioning itself as the trusted partner for ophthalmic innovation worldwide.