APP, Research

University of Rochester•City of Rochester, NY

29d•$98,010 - $137,218•Onsite

About The Position

The Department of Medicine at the University of Rochester Medical Center is a prominent leader in pioneering work in the fields of basic, foundational, clinical, and translational research. We are committed to fostering cutting-edge research that delivers new preventive and therapeutic strategies from the bench to the bedside. This individual will have a multifaceted role supporting clinical research in the role of sub-investigator for the division of Infectious Diseases (Infectious Diseases Research Clinic - IDRC). As a leader of clinical research for the Division of Infectious Diseases, this individual will work with and provide clinical oversight for a dynamic and highly busy research clinic with multiple contracts from the NIH and pharmaceutical companies. They will contribute to the development and implementation of research initiatives at the Infectious Diseases Research Clinic (IDRC) with emphasis on project milestones and goals for the University of Rochester Vaccine Treatment Evaluation Unit (UR VTEU), a 7-year NIH-funded grant to perform clinical studies as a part of the large NIH network called the Infectious Diseases Clinical Research Consortium (IDCRC). This individual will directly report to the IDRC Primary Investigators. Exceptional organizational skills are required.

Requirements

Advanced Practitioner clinical degree required
2 years of clinical research or relevant work experience required or equivalent combination of education and experience
Fluent English language skills (oral and written).
PA – Physician Assistant upon hire required

Nice To Haves

1 year of experience as a Physician Assistant or equivalent combination of education and experience preferred
Demonstrated leadership skills and competency preferred
Ability to effectively manage complex research protocols/procedures preferred
Proficiency in medical terminology, the clinical research process and applicable regulatory guidelines and standards preferred
Proficiency in managing multiple and competing priorities/demands preferred
Exceptional interpersonal, organizational, and time management skills; highly collaborative, promotes teamwork preferred
Ability to build collaboration among research team members, laboratory staff, patients and families, clinical services (requires tact, sensitivity, clarity, flexibility, empathy for patients) preferred
Proficiency in MS Office (e.g. Word, Excel, and PowerPoint), email, and internet preferred
Possesses a high degree of self-motivation; recognized ability to function independently preferred

Responsibilities

Provides guidance to research coordinators and nurses for clinical evaluation and assessment related to study procedures and participants
Provides coverage and backup for IDRC physicians in the role of physician assistant as a sub-investigator for all IDRC clinical trials once credentialled
Perform a health history, including sexual history and behavioral risk assessment, and targeted physical examination
Assess clients’ suitability for active and upcoming research studies.
Perform venipuncture
Administer Investigational Product
Provide individualized patient education
Identifies other health problems and provides referrals to appropriate health providers for evaluation and management
Evaluation of severity, causality, and relationship of Adverse Event/Medically Attended Adverse Event/Serious Adverse Event/Adverse Event of Medical Interest
Follow up on the above until stability or resolution
Review of subject laboratory test results as related to study participation
Subject safety reporting to Sponsor and Regulatory agencies
Estimated number of subjects will average 25-30 per week, in clinic visits
IDRC – Works with the clinical research manager to provide programmatic support for research activities to effectively manage available resources (personnel, space, supplies, computers, and office equipment)
Consult with the IDRC and UR VTEU PIs, other UR VTEU faculty, and IDRC research staff concerning the studies and projects to be conducted to evaluate, create protocols, and achieve deliverables of research protocols and objectives.
Works with Clinical Trials Manager to create process improvement evaluations for recruitment, enrollment, and subject payment for the IDRC.
Identifies roadblocks and logistical issues and independently creates and implements strategies to accelerate the workflow and achieve deliverables.
Leads protocol implementation and study progress, keeping investigators appraised of study progress.
Implement strategies to increase accrual and perform second eligibility checks.
Assists in training research coordinators, research nurses, and other staff on clinical activities associated with conducting human subject research specific to study protocols and generally in compliance with Good Clinical Practice (GCPs) guidelines and sponsor requirements.
Provides coverage and backup for Clinical Research Coordinators as needed.
IDRC Assists with managing the clinical research pipeline portfolio, including the following tasks:
Effectively communicates with the research team, sponsor, data coordinating centers, compliance monitors, collaborators, investigators’ academic administrative personnel, and other departments.
Demonstrates accountability for continuous learning in accordance with Good Clinical Practice standards and guidelines.
Assumes personal responsibility for keeping up with new developments in the field, related literature, and relevant clinical standards and trains other clinical research staff to do the same.
Maintain Compliance with internal regulations and external partners:
Contribute to the design of the study protocol processes, including the development and maintenance of standard operating procedures.
Develops and implements strategies to promote adherence to cultural competency guidelines and meet participants’ needs for language translation, health literacy, etc.
IDRC - Assists Sr. Quality Assurance Manager with the monthly QA review of all DMID studies:
Partners with PIs and QA Manager in preparing and assessing project-specific reports as well as the UR VTEU annual report for the NIH.
Works to improve the quality and timeliness of submitted reports.
Conducts quality checks to ensure audit-readiness.
Prepares documents for and participates in external monitoring visits to ensure compliance.
Represents URMC, Medicine, and the Infectious Disease Department in communications with regulatory bodies, including the NIH, pharmaceutical sponsors, and local IRB.