Principal Investigator - Internal Medicine

About Us

CenExel’s research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well-respected and long-standing research facilities in the country. Specialty areas of research include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each site has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success. Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full-time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Insurance, and 401k.

Job Summary

Responsible for conducting clinical trials in accordance with the research protocol, Good Clinical Practices (GCPs), and federal/state regulations. Generates independent, high-quality, and reproducible results. Collaborates with our study team, as well as various medical, pharmaceutical company, and regulatory personnel to ensure the health and welfare of study participants. Responsible for the management and integrity of the design, conduct, and reporting of the research project and for managing, monitoring, and ensuring the integrity of any collaborative relationships. Responsible for the direction and oversight of compliance, financial, personnel, and other related aspects of the research project.

Essential Responsibilities And Duties

• Maintain current license to practice medicine.
• Maintain current board certification, if applicable.
• Assume responsibility as the Principal Investigator for the duration of clinical trials.
• Strong working knowledge of regulatory requirements and GCP standards.
• Possess thorough understanding of the clinical research protocol and patient population for which the trial is designed.
• Ensures recruitment goals are reasonable and attainable.
• Performs any evaluations deemed necessary for the conduct of the trial.
• Completes training as required per sponsor’s vendors to obtain certification to conduct testing and rating scales for specific protocols.
• Conducts testing and rating scales per sponsor’s instructions and protocols. Completes all documentation, paper and electronic, as required per protocol.
• Evaluates participants for clinical research trials based on their past medical history in comparison to the protocol-specific inclusion and exclusion criteria.
• Ensures appropriate delegation and training of the clinical research staff.
• Edits study staff on patient population and mechanism of action of the investigational product.
• Evaluates subject safety and compliance with the investigational product as specified in the clinical research protocol as well as collaborates with the medical director.
• Affirms participant’s response to investigational therapy and evaluates any adverse events.
• Adheres to reporting requirements for safety reports, protocol non-compliance, and any other protocol-required reports.
• Ensures subject’s informed consent is obtained appropriately throughout the duration of the clinical trial.
• Affirms adherence to the requirements detailed on the FDA 1572 or Statement of Investigator form.
• Collaborates with Site Leadership to ensure company goals are met.
• Attends Investigator Meetings and educational seminars.
• Assumes other duties and responsibilities as assigned.

Education/Experience/Skills

• Must be able to effectively communicate verbally and in writing.
• Possess a valid M.D. or D.O. degree. Board Certified or Eligible.
• 1-3 years’ experience conducting clinical research trials as either a PI or Sub-investigator, or other relevant experience.
• D.O. required.
• Active DEA license, or able to obtain one.
• Active license to practice medicine in the state of practice, or ability to obtain one.
• Medical knowledge and ability to provide clinical information to study teams.
• Knowledge of medications and general medical conditions.
• Knowledge and Understanding of GCP/ICH guidelines.
• Possess a thorough understanding of the requirements of each protocol.
• Experience in conduct of clinical trials.
• Demonstrating the proper education, training, and experience to conduct the clinical investigation.
• Knowledge of drug delivery systems and ability to prepare injections, infusions, etc.
• Skill in organization and record maintenance.
• Skill in developing and maintaining effective working relationships with supervisors and co-workers.
• Skill in completing paperwork with precision and attention to detail.
• Skill in reacting calmly and effectively in emergency situations.
• Skill in interpreting, adapting, and applying guidelines and procedures.
• Skill in working independently as well as functioning as part of a team.
• Skill in communicating clearly, both verbally and in writing.