Nurse Practitioner/APP Clinical Research Manager (DOM Infectious Disease)

Nurse Practitioner/APP Clinical Research Manager

We are seeking a Nurse Practitioner/APP Clinical Research Manager who will work as the Site Study Coordinator, a position defined by the NIH as key personnel of the AIDS Clinical Trials Group (ACTG) and the HIV Prevention Trials Network (HPTN), and serves as a critical component of both Johns Hopkins University AIDS Clinical Trials Unit (ACTU) and HPTN. The primary responsibilities of this position are to oversee the coordination, implementation, and outreach components of clinical research trials for the ACTG/HPTN and to function as the primary liaison between the National Institute of Allergy and Infectious Diseases (NIAID) and the Johns Hopkins University, School Of Medicine. The incumbent in this position will also manage research staff, including nurse coordinators, program coordinators, data staff, and outreach workers.

The position works collaboratively within a multidisciplinary research team and is responsible for complex, standardized patient care procedures, which require experience and specialized training, and which would otherwise be performed by a physician. Additionally, will educate study participants in matters pertaining to health maintenance, disease prevention, protocol participation and conduct, and appropriate measures in acute and chronic illness. Direct supervision will be provided by an appropriate licensed physician as designated.

Specific Duties & Responsibilities

Administrative

• Facilitate implementation of clinical research protocols in coordination with hospital, departmental, and clinical personnel, such as pharmacy, obstetrics/gynecology, pediatrics, clinical pharmacology, and neurology.
• Maintain proficiency across all clinical protocols and guidelines to serve as an effective resource for all staff.
• Act as central liaison between staff and research and data monitoring centers, including NIAID AIDS Program Office, sponsoring pharmaceutical companies, the pediatric ACTU, the HPTN unit, and clinical pharmacology.
• Serve as primary liaison between ACTU/HPTN and the site monitoring contractor for NIAID. Review outcomes of each audit in person with the monitor, review/correct the resulting report, which is submitted to the NIH.
• Represent the JHU clinical research site, comprised of the ACTU and HPTN units, at annual and/or semi-annual national meetings.
• Represents the JHU ACTU at the annual national leadership retreat.
• Chair weekly staff meeting to disseminate protocol information, balance staff workloads, and design strategies for dealing with current and potential problems.
• Coordinate and assist research nursing staff in preparing for site auditing visits by data monitoring centers.
• Coordinate the orientation and specific research-related training of new staff members, RNs, and outreach workers.
• Oversee daily operations for research studies. Assess protocol staffing and material requirements, e.g., clinic space, data needs, administrative functions, etc.
• Oversee the Quality Management System, including quality assurance and quality control procedures and data collection tools.
• Navigate IRB approval of protocols and assist staff with preparation of original and renewal submissions of ACTG protocols, including discussing the rationale, design, safety profile, and writing the informed consent documents for submission to the IRB and the General Clinical Research Center (GCRC).
• Oversee submission of protocol related reports, summaries, and other required materials to the IRB.
• Provide staff education and training regarding all new protocols.
• Oversee the collection, recording, and reporting of all data by research nurses and data staff.
• Communicate with the PI regarding research and clinical progress.
• Oversee monitoring of patient's health status and lab values while on study and make necessary medication modifications within protocol guidelines.
• Assist in developing recruitment methods to ensure adequate patient accrual into protocols.
• Assist pharmacy staff in developing protocol implementation plans for management and dispensation of study medications.
• Ensure regulatory compliance of pharmacy staff.
• Review and report all safety reports distributed by DAIDS.
• Oversee regular and timely completion of required NIH monthly and quarterly patient status reports.
• Collaborate with GCRC Staff to ensure appropriate training and compliance with visit procedures.
• Coordinate laboratory specimen processing, storage, and shipping with lab supervisors.
• Maintain confidential records of research trials according to FDA, HIPAA, A and OHRP guidelines.
• Disseminate information on policy decisions made by the sponsor and data monitoring center to the Principal Investigator and research staff.

Supervisory

• Create and revise position descriptions for staff as needed.
• Work with HR to ensure an efficient selection process for new staff.
• Contribute to hiring decisions and effective performance management.
• Manage personnel, which includes research nurses and research assistants, data staff, and outreach workers.
• Set priorities to ensure deadlines are met.
• Develop procedural guidelines and adhere to personnel policies.
• Assist staff with problem-solving and prioritization as needed.

Research

• Ensure compliance of all staff with FDA, NIH, and protocol regulations by maintaining familiarity with all active protocols and their respective data collection instruments.
• Provide back-up to research nursing staff in the conduct of ACTG protocols, e.g., assist with screening, obtain informed consent, collect data when necessary, and interpret protocol.
• Evaluate protocol violations and take appropriate follow-up actions.
• Oversee adverse event reporting to the study sponsor for accuracy and timeliness.
• Participate nationally as a member of core protocol teams to help write protocols and develop case report forms for the data collection process.
• Support research nurses by performing physical examinations as required per protocols, reviewing medical history, interval history, and presenting signs and symptoms as needed.

Nurse Practitioner Skills

• Develop a collaborative relationship with the supervising physician and determine the need for and timing of communications.
• Recognize differences between normal and abnormal findings and discuss significant findings with a physician as appropriate.
• Order and interpret laboratory tests, x-rays, diets, or other services per protocol.
• Perform injections and venipuncture as needed per protocol.
• Initiate basic/advanced life support in response to emergencies.
• Demonstrate proficiency with the most common procedures that PAs are expected to perform.
• Exchange routine medical information with appropriate members of the study and health care teams while maintaining patient confidentiality.
• Independently access patient information, develop a treatment plan, and disposition patients in an efficient and effective fashion.
• Other duties as assigned.

Additional Responsibilities may include

• Working on industry-supported clinical trials for infectious disease diagnostics, therapeutics, and other interventions that reduce the morbidity and mortality associated with infectious diseases.

• Master's Degree in Nursing, Registered Nurse license, and certified as a Nurse Practitioner.
• Must be licensed as an NP in the State of Maryland or another state where practicing.
• Current CPR certification.
• Three years of experience in a related clinical area and obtained proficiency in the area of specialty.
• Experience in the medical management of HIV-infected patients: knowledge of HIV infection, clinical management, and related opportunistic infections.
• Experience complying with federal (NIH, FDA, HIPAA) regulations and Good Clinical Practice Guidelines.
• Experience in all aspects of protocol implementation and data management.

• A minimum of ten years of experience in research and management.