Sub-Investigator (NP)

Professional Case Management•Garden City, MI

9d•Hybrid

About The Position

Put your talents to work at PCM! Whether you work in our Home Care, Clinical Research, Impairments, or Catastrophic Care division, you will support our mission to deliver care and other services that enhance the quality of life of our clients. Be a part of our dynamic client-focused team and make a difference in your career! As an Sub-Investigator (Nurse Practitioner), you will deliver high quality, patient-centered care through mobile health clinics at our permanent community Mobile Research Unit or occasionally through home health visits. The Sub-Investigator (Nurse Practitioner) is responsible for ensuring participant safety, data integrity, data quality, and maintenance of protocol standards in various therapeutic areas. As an Advanced Practitioner, you will assist various virtual Principal Investigators (vPIs), through delegated authority, with conducting clinical trials per federal, state, and institutional guidelines, while learning the responsibilities during all phases of trials from pre-study implementation through study closure. In addition to study processes and procedures, the Sub-Investigator (Nurse Practitioner) will support our fleet team with daily unit maintenance, temperature monitoring, and inventory management. This role is all encompassing to ensure efficient study conduct and site procedures.

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.
One (1) year of recent clinical research experience preferred.
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

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 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.