Principal Investigator (Clinical Research)

Position Overview

The Principal Investigator (PI) is a critical leader in the design, conduct, and oversight of clinical investigations involving drugs, biological products, or medical devices. The PI ensures compliance with all regulatory requirements, protects the rights, safety, and welfare of study participants, and maintains the integrity of the data generated. This role demands a deep understanding of clinical research regulations, a commitment to ethical research practices, and a proactive approach to managing research teams and study protocols. The PI will take overall responsibility for the conduct of clinical trials, including protocol development, data accuracy, compliance with Good Clinical Practice (GCP), and interaction with Institutional Review Boards (IRB), sponsors, and regulatory authorities. This position offers a meaningful opportunity to advance medical science and improve patient outcomes through rigorous and ethically conducted research. This role is integral to advancing medical science while upholding the highest ethical and regulatory standards. We seek a dedicated and knowledgeable Principal Investigator ready to make a meaningful impact on healthcare innovation.

Essential Duties & Responsibilities·

• Clinical Study Oversight: Personally conduct or supervise the clinical investigation to ensure compliance with federal regulations, state laws, and organizational policies. Protect the rights, safety, and welfare of all study participants. Oversee the delegation of study tasks to qualified personnel and ensure all team members are trained and equipped for their responsibilities.
• Regulatory Compliance: Ensure adherence to FDA regulations (21 CFR 312.60-69, parts 50 and 56) and ICH Good Clinical Practice (ICH E6) guidelines. Obtain and document informed consent from study participants in accordance with IRB-approved procedures. Maintain accountability for investigational product usage, storage, and randomization processes.
• Protocol Development and Execution: Design scientifically sound protocols with clear objectives and methodologies. Secure IRB approval and ensure all amendments are reviewed and approved before implementation. Ensure timely submission of reports, including continuing review progress, protocol deviations, and adverse events, to IRBs, sponsors, and regulatory authorities.
• Data Integrity and Management: Ensure the accuracy, security, and integrity of research data and records. Adhere to pre-planned protocol analysis plans and utilize accepted statistical principles for data analysis and reporting. Store, retain, and protect data and study records in compliance with HIPAA and applicable regulations.
• Team Leadership and Collaboration: Provide oversight of all study activities and personnel, ensuring adequate resources (time, staff, funding, and space) for research success. Collaborate with multidisciplinary teams, sponsors, and regulatory authorities to ensure research objectives are met. Serve as a mentor to research staff, fostering a culture of compliance, integrity, and excellence.

Qualifications·

• Education and Licensure: The Principal Investigator must be a licensed physician (M.D. or equivalent) or possess a PhD or a PharmD degree. Minimum of 3 years of experience conducting Phase I clinical trials.
• Experience: Proven track record of managing complex trials and compliance with FDA and ICH regulations. Demonstrated experience leading Phase I clinical trials and managing multidisciplinary teams.
• Skills and Attributes: Strong knowledge of clinical trial regulations, including 21 CFR 312 and 812, and ICH E6 guidelines. Exceptional analytical, problem-solving, and organizational skills. Outstanding communication and leadership abilities. Commitment to protecting the rights and welfare of research participants.

Responsibilities Related to Human Subjects Research

• Ensure protocols are scientifically sound and adhere to ethical standards.
• Provide oversight for obtaining informed consent and child assent (if applicable) following IRB requirements.
• Maintain meticulous records, adhering to HIPAA, FDA, and institutional policies for data security and integrity.
• Address unanticipated problems and implement immediate corrective actions to eliminate hazards to study participants, reporting promptly to IRBs and regulatory authorities.

Work Environment:

• The role may involve work in laboratories, clinical environments, and office settings.
• Flexibility to adapt to a dynamic and fast-paced research environment.

Physical Demands:

• Ability to work at a laboratory bench for extended periods.
• Occasional lifting of materials related to drug preparation and storage.

Equal Opportunity Employer

Phronetik is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Note on Contingent Employment

This position is contingent upon Phronetik being awarded the corresponding government contract. As part of the hiring process, candidates selected for this role will be required to sign a Letter of Commitment confirming their intent to join the company upon successful contract award.

Phronetik, as a small business government contractor, is unable to finalize employment until the contract is officially awarded. This ensures that all hiring aligns with federal requirements and contract needs.

Job Types: Full-time, Contract

Pay: $54.77 - $68.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Education:

• Doctorate (Preferred)

Experience:

• Phase I Clinical Trial: 3 years (Required)

License/Certification:

• M.D. or equivalent, or possess a PhD or PharmD degree? (Required)

Ability to Commute:

• Plano, TX 75074 (Required)

Work Location: In person

Salary : $55 - $68