Principal Investigator (PI) for Clinical Research

Summary: Responsible for administering activities to facilitate clinical research and providing clinical support for the conduct and oversight of clinical trials.

 Duties and Responsibilities include the following. Other duties may be assigned.

•  Works with affiliate or collaborating research sites.*
•  Principal Investigator is the primary individual responsible for the preparation, conduct, and administration of all designated projects in compliance with applicable laws and regulations and institutional policies.*
•  Maintains subject and document confidentiality at all times and understands and complies with the appropriate sponsor requirements, regulations including the Food and Drug Administration, good clinical practice, International Conference on Harmonization, Health Insurance Portability and Accountability Act, Institutional Review Boards, and institutional policies and procedures.*
•  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. *
•  Reviews and holds expert knowledge of study related activities and protocols.*
•  Adheres to study protocols, Food and Drug Administration regulations, and good clinical practices at all times.*
•  Assists in the preparation for study monitor visits.*
•  Performs subject screening and recruitment.*

Language Ability:

Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to write speeches and articles for publication that conform to prescribed style and format. Ability to effectively present information to top management, public groups, and/or boards of directors.

Computer Skills:

To perform this job successfully, an individual should have knowledge of Microsoft Office, Microsoft Excel, Internet Explorer, Google Chrome, Mozilla Foxfire, and web based enterprise solutions software.

Education/Experience:  One to two years research experience as a principal investigator GI +/- liver disease preferred.

Certificates and Licenses:

Current Physician License. Board Certified preferred.

Knowledge, Skills, and Other Abilities:

• Oral and written communication skills
• 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

Pinnacle Clinical Research PLLC is an EEO employer - M/F/Vets/Disabled