Priciple Investigator

We are seeking a dedicated and experienced Principal Investigator (PI) to join our Phase I Clinical Research Unit. Ideal candidate will possess an MD degree and have at least 5 years of clinical experience. Clinical research experience is not required, but the ability to lead a team is.

 The Principal Investigator will be responsible for a variety of specialized clinical research activities, ensuring that established protocols are implemented, maintaining protocol integrity, monitoring participants' status and safety, and playing a significant role in the education of clinical staff and clinical trial participants.

 What You'll Do:

•  Lead and oversee clinical trials in Phase I, ensuring adherence to all regulatory and ethical guidelines.
• Provide medical expertise and oversight for study participants, ensuring their safety and well-being throughout the trial.
• Conduct physical examinations and review medical histories of study participants.
•   Collaborate with cross-functional teams to develop study protocols, including the selection of appropriate endpoints and safety assessments.
• Ensure proper implementation of study protocols and make necessary adjustments to protocols as required.
•   Review and interpret clinical data to ensure accuracy and completeness.
• Collaborate with biostatisticians and other team members to analyze study results and prepare clinical study reports.
•   Ensure all clinical trials are conducted in compliance with Good Clinical Practice (GCP) guidelines, FDA regulations, and other applicable regulatory requirements.
• Prepare and submit required documentation to regulatory authorities.
•   Communicate effectively with study participants, explaining the trial process, potential risks, and benefits.
• Obtain informed consent from participants and address any concerns they may have.
•   Lead a multidisciplinary team of clinical research professionals, including nurses, coordinators, and data managers.
• Foster a collaborative and productive working environment, providing guidance and mentorship to team members.
•  Oversee all staff involved in obtaining informed consent from potential participants.
• Be available to provide medical advice and support in case of emergency or unanticipated serious incident.
•   Attend dosing of studies and review adverse events to determine the relationship of the event to the investigational drug.
• Review and complete case report forms.
• Ensure subject safety throughout participation.
• Provide consultation to scientific staff and study sponsors in the design, implementation, conduct, and reporting of research studies.
• Support activities related to clinical studies, including meeting with study sponsors, and providing input to scientific staff on study design.
•  Work closely with the Medical Director to develop and implement policies and procedures that ensure high-quality service.
• Provide oversight to all staff involved in study execution as signatory on FDA Form 1572.
• Function as the Principal Investigator or Sub-Investigator for Clinical Research Studies, ensuring all protocol guidelines are met.
• Provide medical safety review of clinical research protocols as requested by sponsors.
• Maintain external relationships with physicians, hospitals, and community health centers to assist with study needs and participant recruitment.
•  Evaluate clinical laboratory and study examinations.
• Monitor and document all participants' adverse events, medical conditions, and responses to study medications and treatments.
• Attend industry events to ensure optimum exposure of Company.

What You'll Need:

•  MD degree from an accredited medical school.
• Board certified by a specialty board approved by the American Board of Medical Specialties.
• Minimum of 5 years of clinical experience in a healthcare setting.
•  Excellent communication and interpersonal skills.
•  Ability to work effectively in a team-oriented environment.
• High level of attention to detail and strong organizational skills.
• Current and valid state medical licensure.
• Current CPR Certification is required.
• ACLS Certification is required.
• Knowledge of state and federal laws and FDA regulations governing healthcare, clinical research, and pharmaceutical drug development.
• Good Clinical Practice (GCP) knowledge.
•  Previous experience in clinical research, though not required, is a plus.
• Specialty in Internal Medicine, Emergency Medicine, or Family Medicine.
• Maintains current DEA license.

What You'll Get:

•  Competitive salary and benefits package.
•  Opportunity to work on cutting-edge clinical trials and contribute to the development of new therapies.
• Supportive and collaborative work environment.
• Professional development and career advancement opportunities.
• Generous benefits program including health, dental, vision, dependent care, and health flexible spending account, vacation, holiday and sick pay, short and long-term disability, life insurance, and 401(k).

 Work Schedule:

•  Full-time
• Monday to Friday, weekends as needed