Sub-Investigator (Nurse Practitioner)

Professional Case Management

About The Position

At Professional Case Management (PCM), our mission drives us. We have a growing team of over 4,000 employees who are passionate about delivering care that enhances the quality of life of clients in the most healing of environments – the home. We believe that aligning genuine, caring team members with this purpose is life-changing for our clients, customers, and teammates alike. And it’s our goal to consistently stretch ourselves – and the organization – to ensure we’re always learning, growing, and elevating our standards of service. In everything we do, we share a strong set of core values: We Work As A Team, We Do The Right Thing, We Figure It Out, We Pursue Growth, and We Take Ownership. PCM has been an industry leader in delivering specialized in-home care and other services to clients for over 30 years. Our Home Care division is the nation’s premier Home Healthcare provider to former nuclear weapons and uranium workers, upholding the highest standards of care through accreditation by the Accreditation Commission of Health Care (ACHC).

Requirements

Advanced practice degree NP
Two (2) year of experience as an Advanced Practitioner
Two (2) year of experience starting and performing phlebotomy, IVs, subcutaneous injections, collecting vital signs, ECG, and urine collection.
Excellent computer Skills, including Microsoft Outlook, Word, Excel, and PowerPoint.
current unrestricted licensure to practice as an Advanced Practitioner (NP or PA) in the state to which the candidate is assigned.
Current BLS certification required.
Excellent verbal and written communication.
Experience collecting, processing, and shipping lab specimen(s).
Use of considerable judgment/critical thinking in application of procedures, nursing assessment techniques, practices, and policies to work problems, organization, and administration of research or outpatient clinic.
Working knowledge of federal, state, and local laws and regulations governing research.
Ability to provide patient-centric focus.
Adaptability/flexibility to react positively to changes in work environment.
Initiative to improve productivity and quality of work.
Ability to plan and organize work in logical and efficient manner.
Ability to manage time delicate projects to meet deadlines.
Strong attention to detail.
Excellent ability to establish and maintain effective working relationships.
Prolonged periods of sitting at a desk and working on a computer.
Prolonged periods of standing, bending, and reaching.
Must be able to lift up to 50 pounds at times.
Have the ability to travel, a valid state driver license and able to drive a car, proof of adequate automobile insurance coverage for the state of residence.
Ability to travel regionally by car or nationally by plane.
Possess cellular phone, reliable transportation, and access to the internet.

Nice To Haves

One (1) year of recent clinical research experience preferred.
CITI, GCP, and IATA preferred.

Responsibilities

Serves as a leader to the study team to execute clinical trials by mentoring and training staff in the conduct of clinical trials, protocol requirements, communication, and trial management skills.
Screens and confirm subject eligibility in assigned clinical trials in accordance with the Health Insurance Portability and Accountability Act (HIPAA) standards.
Performs pediatric, adult, and geriatric participant visits, including but not limited to medical history collection, medication reconciliation, physical exam, and health education.
Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines and SOPs.
Implement and coordinate assigned clinical trials including start up, vendor management, subject recruitment, source development review, scheduling subjects, protocol training, collection of regulatory documents, conducting visits, ensuring data is entered in a timely manner and all queries are resolved, managing, and reporting adverse events, serious adverse events, and deviations, implementing new protocol amendments, providing all close out reports.
As delegated, administers medications, investigational products, and vaccinations.
As delegated, assess serious and adverse events as related to investigational product.
Incorporate understanding of product development lifecycle and significance of protocol design including critical data points when planning for each assigned protocol
Perform clinical duties (e.g., Drug preparation and administration, phlebotomy, ECG, lab processing) within scope.
Assists in coordinating research subject's consent and entry into appropriate research studies ensuring that all inclusion and exclusion criteria are met.
Assist with electronic data entry.
Reviews new protocols and other materials provided by study sponsors and gives input to the Principal Investigators (PIs), site leadership, and virtual Clinical Research Coordinators, as applicable, regarding nursing and research issues in order to resolve financial and clinical feasibility.
Helps ensure that all study related activities are complete including returning supplies, returning unused stock of study drug/devices, and confirming that all queries are complete.
Maintains current knowledge of departmental functions through reading literature, attending workshops, seminars, and conferences, and by participating in professional organizations.
Assists in conducting audits of research studies to check the accuracy, integrity, and consistency of the research studies.
Works collaboratively with physicians, nurses, clinical research specialists, leaders, family members, key care givers and any ancillary medical personnel as appropriate.
Follows ALCOA +C good documentation practices.
Maintains compliance with OSHA, HIPPA and State Board of Nursing.
Supports Community Engagement team with building the community and developing relationships within that community to assist with the recruitment of participants, such as attending community events, speaking with physicians / healthcare professionals and people across diverse cultures and backgrounds.
Evaluate potential subjects for participation in clinical trials including phone and in person prescreens.
Create and execute recruitment strategies in conjunction with patient recruitment staff.
Performs other duties as assigned including but not limited to home visits, recruitment, and community engagement activities, which may occur after hours and/or on weekends.
Regular and reliable attendance with the ability to work after hours/weekends as needed as well as rotating on-call shifts that may include weeknights, weekends, and holidays.
Any other duties needed to help drive to our vision, fulfill our mission, and abide by EmVenio’s values.