Sub-Investigator - Nurse Practitioner/Physician Assistant

Job Title: Sub Investigator

Reports To: Site Director / PI

FLSA Status: Exempt

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.

Summary: PCR CRCNJ seeks a Clinical Research Advanced Nurse Practitioner/Physician Assistant who will be listed as a Sub Investigator on ongoing study protocols. The Sub Investigator will be a key member of the team and will be responsible for seeing follow up visits, reviewing labs for study subjects, recruiting subjects into protocols, and working with the clinical operations team.

Duties And Responsibilities

• Works with affiliate or collaborating research sites.
• 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 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.
• Exercises judgement within the allowable limits defined within clinical trials protocols, standard operating procedures, and under the direction from the principal investigator.
• Interacts with internal and external personnel such as physicians, nurses, administration staff, industry sponsor representatives, central laboratory and imaging personnel, and clinical trial patients.
• Coordinates multiple projects with competing priorities and deadlines as needed based on clinical trial protocol directives and study volume.
  
  

Education/Experience

• Advance degree from a graduate school; and one to two years related experience and/or training; or equivalent combination of education and experience.
• Specialization in geriatrics, internal medicine, or family medicine
• Ability/certification to do infusions is a plus
• Experience with pharma-sponsored clinical trials strongly preferred
  
  

Certificates And Licenses

• Current advanced registered nurse practitioner or physician assistant license.
• Valid driver’s License
• GCP Training certification 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 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.
• 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.
  
  

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.