Advanced Practice Provider - Sub Investigator PRN

Sub-investigator on all ongoing study protocols and a key member of the clinical research team.

Responsibilities

• Works with affiliates or collaborating research sites.
• Maintains subject and document confidentiality; complies with sponsor requirements, FDA regulations, Good Clinical Practice (GCP), International Conference on Harmonization (ICH), Health Insurance Portability and Accountability Act (HIPAA), Institutional Review Boards (IRBs), and institutional policies and procedures.
• Performs study-related procedures including physical examinations, informed consent, subject history, adverse event reporting, test article handling, appointment scheduling, records review, treatment coordination, collecting vital signs, and subject health assessments.
• Reviews and maintains expert knowledge of study protocols and related activities.
• Adheres to study protocols, FDA regulations, and GCP at all times.
• Assists in preparation for study monitor visits.
• Performs subject screening and recruitment.
• Exercises judgment within allowable limits defined by clinical trial protocols, standard operating procedures, and under the direction of the principal investigator.
• Interacts with internal and external personnel including physicians, nurses, administration staff, industry sponsor representatives, central laboratory and imaging personnel, and clinical trial patients.
• Coordinates multiple projects with competing priorities and deadlines based on clinical trial protocol directives and study volume.

Requirements

• Advanced degree from a graduate school.
• One to two years of related experience and/or training; or equivalent combination of education and experience.
• Specialized training.
• Current advanced registered nurse practitioner or physician assistant license.
• Valid driver’s license.
• GCP Training certification preferred.
• Bilingual (English/Spanish) required.

Skills

• Written and oral communication skills.
• Organizational skills and attention to detail.
• People skills including a positive, friendly, and professional demeanor.
• Flexibility with changing priorities.
• Diplomatic and professional communication.
• Strong interpersonal skills.
• Strong mathematical knowledge.
• Excellent computer skills including Microsoft Office, Internet Explorer, Google Chrome, Mozilla Firefox, and web-based enterprise solutions software.

Work Environment and Physical Demands

• Work is performed in an office, laboratory, and/or clinical environment.
• Exposure to biological fluids and/or bloodborne pathogens; personal protective equipment (e.g., protective eyewear, garments, gloves) required.
• Occasional domestic and/or international travel may be required.
• 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.

Benefits

• 401k.
• Medical, dental, vision, long-term disability, short-term disability, FSA, and life insurance.
• 3 weeks of paid time off.
• 13 paid company holidays.
• Tranquility Room (specific locations apply).
• Pinnacle Gym (specific locations apply).
• Scrub voucher (specific positions apply).