Clinical Research Nurse Practitioner/Physician Associate

Summary: The Clinical Research Nurse Practitioner/Physician Associate will be listed as a sub-investigator on all ongoing study protocols. She/He 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 time.
• 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. Specialized training.

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:

• Bilingual (English/Spanish) required
• 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.