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The Sub Investigator serves as a key team member responsible for conducting follow-up visits, reviewing labs, and recruiting subjects for study protocols. They perform clinical procedures and ensure strict adherence to FDA regulations and Good Clinical Practice (GCP) guidelines.
Requirements summary
Candidates must hold an advanced degree and a current license as a Nurse Practitioner or Physician Assistant. Proficiency in both English and Spanish is required, along with one to two years of related experience.
professional certificatepostgraduate degreePatient AssessmentInterpersonal CommunicationPhysical ExaminationsMicrosoft OfficeTreatment CoordinationClinical ResearchPatient RecruitmentBilingual English/SpanishInformed ConsentMedical Record ReviewGCP ComplianceSubject Screening
Job description
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 affiliates 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. Specialized training.
Certificates and
Licenses:
Current advanced registered nurse practitioner or physician assistant license.
Benefits
Dental Insurance
Life Insurance
Paid Time Off
Vision Insurance
Medical Insurance
401k
FSA
Short Term Disability
Long Term Disability
Paid Company Holidays
Gym Access
Scrub Voucher
Tranquility Room
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 is 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
13 paid company holidays
Tranquility Room (specific locations apply)
Pinnacle Gym (specific locations apply)
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
