What are the responsibilities and job description for the Principal Investigator position at Pinnacle Clinical Research, LLC?
Come join our team and make a difference as we blaze the way into the future of medical discovery through world-class clinical research. At Pinnacle Clinical Research, we are committed to driving innovation and advancing medical knowledge. Through our rigorous research studies, we strive to unlock breakthroughs that have the potential to transform patient care and improve lives. We pride ourselves on conducting high quality research as a complement to the medical care that our volunteers receive from their routine care center. Together, we will raise awareness about the importance of clinical research and its role in shaping the future of healthcare. Be a part of the discovery!
Summary: Responsible for administering activities to facilitate clinical research and providing clinical support for the conduct and oversight of all phases of clinical trials.
Duties and Responsibilities:
- Works with affiliate or collaborating research sites.
- The 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.
- Provides some weekend coverage to facilitate study visits per protocol.
- Provides after-hours phone call coverage as needed.
- Oversee Sub-Investigators and recruitment team.
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:
- Written and oral 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
- 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 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.
- Occasional travel may be required domestic and/or international.
- Ability to work in an upright and/or stationary position for 6-10 hours per day.
- Frequent mobility required.
- Occasional squatting, kneeling, or bending.
- Light to moderate lifting and carrying (or otherwise moves) objects including medical equipment with a maximum lift of 20-50 lbs.
Perks of working at Pinnacle Clinical Research:
- 401k
- Medical, dental, vision, long term disability, short term disability, FSA, and life insurance
- 3 weeks of paid time off
- 14 paid company holidays
- Tranquility Room
- Pinnacle Gym
- Scrub voucher (specific positions apply)
- And more!
Pinnacle Clinical Research is an equal-opportunity employer. All applicants will be considered for employment without regard to race, color, religion, disability, gender, national origin, age, genetic information, military or veteran status, sexual orientation, gender identity, marital status, or any other protected Federal, State/Province or Local status unrelated to the performance of the work involved.