Principal Investigator

Summary

The Clinical Research Physician Investigator or PI is responsible for administering activities to facilitate clinical research and providing clinical support for the conduct and oversight of clinical trials.

The PI agrees to assume the overall responsibility for the study conduct. By doing so, inherently agrees to:

• Personally conduct or supervise the research
• Ensure that each individual to whom a task is delegated is qualified by virtue of education, training, and experience to perform each of their delegated tasks
• Protect the rights, safety and welfare of the participants who will be under their care. To do this they are agreeing that the research:
• Is conducted in accordance with all federal regulatory requirements, state law and company policies (including SOPs)
• Is conducted in accordance with the IRB approved plan
• That they will ensure the accuracy, security and integrity of the research data and the subsequent analysis of that data.

Duties and Responsibilities:

• Review and hold expert knowledge of study-related activities and protocols.
• Assume all responsibilities and obligations as an Investigator, per Title 21 part 312 and FDA Form 1572.
• Adhere to study protocols, FDA regulations, and Good Clinical Practice (GCP) at all times.
• Maintain study sponsor and clinical trial confidentiality.
• Performs study related procedures such as physical examinations, informed consent, subject history, adverse events, test article handling, appointment scheduling, records review, treatment coordination, collecting vital signs, and subject health assessments. Reviews and adjudicates all lab, imaging and biopsy findings.
• Assists in the preparation for study monitor visits.
• Performs subject screening and recruitment.
• Provides some weekend coverage to facilitate study visits per protocol.
• Provides after-hours phone call coverage as needed.
• Oversee Sub-Investigators and recruitment team.

Knowledge, Skills, and Other Abilities:

• Written and oral communication skills
• Bilingual (English and Spanish) strongly preferred
• Organizational skills
• Ability to pay attention to detail
• People skills including possessing a positive, friendly, and professional demeanor
• Ability to be flexible with changing priorities
• Ability to communicate in a diplomatic and professional manner
• Strong interpersonal skills
• Strong mathematical knowledge
• Excellent computer skills
• Knowledge of Microsoft Office, Internet Explorer, Google Chrome, Mozilla Foxfire, and web-based enterprise solutions software.
• Work Environment and Physical demands:
• The work environment and physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Work is performed in an office/laboratory and/or a clinical environment.
• Exposure to biological fluids and/or bloodborne pathogens.
• Personal protective equipment required such as protective eyewear, garments, and gloves.

Job Description

The Clinical Research Physician Investigator or PI is responsible for administering activities to facilitate clinical research and providing clinical support for the conduct and oversight of clinical trials.

The PI agrees to assume the overall responsibility for the study conduct. By doing so, inherently agrees to:

• Personally conduct or supervise the research
• Ensure that each individual to whom a task is delegated is qualified by virtue of education, training, and experience to perform each of their delegated tasks
• Protect the rights, safety and welfare of the participants who will be under their care. To do this they are agreeing that the research:
• Is conducted in accordance with all federal regulatory requirements, state law and company policies (including SOPs)
• Is conducted in accordance with the IRB approved plan
• That they will ensure the accuracy, security and integrity of the research data and the subsequent analysis of that data.

Duties and Responsibilities:

• Review and hold expert knowledge of study-related activities and protocols.
• Assume all responsibilities and obligations as an Investigator, per Title 21 part 312 and FDA Form 1572.
• Adhere to study protocols, FDA regulations, and Good Clinical Practice (GCP) at all times.
• Maintain study sponsor and clinical trial confidentiality.
• Performs study related procedures such as physical examinations, informed consent, subject history, adverse events, test article handling, appointment scheduling, records review, treatment coordination, collecting vital signs, and subject health assessments. Reviews and adjudicates all lab, imaging and biopsy findings.
• Assists in the preparation for study monitor visits.
• Performs subject screening and recruitment.
• Provides some weekend coverage to facilitate study visits per protocol.
• Provides after-hours phone call coverage as needed.
• Oversee Sub-Investigators and recruitment team.

Knowledge, Skills, and Other Abilities:

• Written and oral communication skills
• Bilingual (English and Spanish) strongly preferred
• Organizational skills
• Ability to pay attention to detail
• People skills including possessing a positive, friendly, and professional demeanor
• Ability to be flexible with changing priorities
• Ability to communicate in a diplomatic and professional manner
• Strong interpersonal skills
• Strong mathematical knowledge
• Excellent computer skills
• Knowledge of Microsoft Office, Internet Explorer, Google Chrome, Mozilla Foxfire, and web-based enterprise solutions software.
• Work Environment and Physical demands:
• The work environment and physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Work is performed in an office/laboratory and/or a clinical environment.
• Exposure to biological fluids and/or bloodborne pathogens.
• Personal protective equipment required such as protective eyewear, garments, and gloves.