What are the responsibilities and job description for the Clinical Research Principal Investigator position at Bliss Clinical Research LLC?
Company Description Bliss Clinical Research LLC is a patient-centered clinical research site located in Little Elm, Texas, partnering with Sponsors and CROs to support high-quality clinical trials. The organization is committed to providing a respectful and supportive experience for participants while advancing medical knowledge and improving global health outcomes. Sponsors trust Bliss Clinical Research for reliable data, adherence to protocols, and strong operational performance. The team takes pride in contributing to therapies that help communities heal and in building long-term relationships with stakeholders across the clinical research ecosystem.
Role Description The Clinical Research Principal Investigator (PI) is a Part/full-time, hybrid role based in Little Elm, TX, with a combination of on-site responsibilities and some work-from-home flexibility. The individual will provide overall medical leadership for assigned clinical trials, including reviewing and approving study protocols, overseeing participant eligibility and safety, and ensuring adherence to Good Clinical Practice (GCP), regulatory requirements, and sponsor guidelines. Day-to-day tasks include conducting study-related medical evaluations, obtaining informed consent, reviewing and signing off on source documentation and case report forms, and collaborating with the site coordinator and research staff to maintain protocol compliance and data integrity. The Principal Investigator is also expected to have a large network to support with business development for new trials. He will also participate in sponsor and CRO meetings, respond to safety and efficacy queries, oversee adverse event reporting, and support continuous quality improvement for site operations and patient care. In addition, the role includes mentoring clinical and research staff, contributing to recruitment strategies, and promoting a culture of ethical, compassionate, and evidence-based research.
Qualifications
- Licensed physician (MD or DO) in good standing, with board certification (preferred) or eligibility in a relevant specialty (e.g., internal medicine, family medicine, psychiatry, or other applicable field).
- At least one to two years of clinical practice in Internal Medicine, Behavioral Neurology, Family Practice, Endocrinology, GI /- liver disease, etc.
- Demonstrated experience of at least 1 or 2 years as a Principal Investigator or Sub-Investigator in clinical trials ir preferred, or significant clinical research experience in a regulated environment.
- Strong knowledge of Good Clinical Practice (GCP), ICH guidelines, FDA and other applicable regulatory requirements, and ethical principles in human subject research.
- Ability to conduct thorough medical assessments, evaluate eligibility criteria, oversee safety monitoring, and make sound clinical judgments for trial participants.
- Effective leadership and team collaboration skills, with the ability to guide coordinators and research staff, manage workflows, and support a patient-centered culture.
- Excellent written and verbal communication skills for interacting with patients, site staff, sponsors, CROs, and regulatory bodies, and for accurate documentation.
- Strong organizational and time-management skills to oversee multiple studies, manage competing priorities, and maintain high-quality documentation and data integrity.
- Comfort with electronic data capture systems, EMRs, and basic digital tools used in clinical research; openness to learning new platforms as needed.
- Commitment