Sub-Investigator

Johnson County Clintrials LLC•Kansas City, MO

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About The Position

The purpose of the Sub-Investigator role is to ensure the safe, ethical, and effective medical oversight of volunteers participating in clinical research studies at Johnson County Clin-Trials. This position supports the Principal Investigator by conducting medical evaluations, managing volunteer health throughout study participation, and ensuring adherence to study protocols and regulatory requirements. Through expert clinical assessment, collaborative teamwork, and strong communication, the Sub-Investigator helps maintain high-quality research standards, safeguards participant well-being, and contributes to the successful execution of clinical trials. The Sub-Investigator position is responsible for providing medical evaluation and care to volunteers enrolled in research studies conducted by Johnson County Clin-Trials. This is performed in conjunction with the Primary Investigator and other members of the multidisciplinary health care team. The Sub-Investigator screens new volunteers medically and manages them while actively participating in a study, and provides follow-up care, as needed. The Sub-Investigator screens new volunteers, provides medical management during study participation, and provides follow-up as, as needed. These activities may be performed in both in-patient and outpatient settings. This medical management includes assessment of acute and non-acute clinical problems and toxicities. Customer service is critical in this role as the Sub-Investigator directly communicates with volunteers and other departments.

Requirements

5 years of previous clinical research experience working directly with clinicians/providers is required
License to practice as a Nurse Practitioner in the state of Kansas
Advanced understanding of regulations governing clinical research (CFR, GCP, HIPAA)
Advanced understanding of statutes and guidelines relevant to regulatory affairs in clinical research
Familiarity with or the ability to learn clinical trial management system software
Experience in customer service, telephone, and computers or equivalent training
Microsoft Office proficiency
Excellent written and verbal communication skills
Ability to work effectively with a team
Ability to manage small projects personally and work independently
Memory to retain information and know where to research answers
Strong time management skills
Effective organizational skills
Detail oriented with the ability to perform at a high level of accuracy
Demonstrates strong analytical, problem-solving skills
Self-motivated
Must be results oriented, multi-tasking, quick learner
Complex problem solving
Excellent interpersonal skills
Ability to establish and maintain effective working relationships with coworkers, managers and volunteers
In depth knowledge of clinical trials
In depth knowledge of Good Clinical Practices (GCP)
Ability to fully contribute to multidisciplinary teams including physicians, and administrative staff to assure that the goals and objectives of the program or project are
Ability to sit, stand, walk, reach with hands and arms, and use hands along with fingers, to handle or feel
Prolonged periods of walking and standing are required
Ability to lift and/or move up to 50 pounds
Ability to bend and stoop
Ability to handle biological materials

Responsibilities

Orders and interprets data obtained from diagnostic tests and laboratory studies
Orders appropriate medications and treatments for study volunteers
Provides volunteer and staff education
Participates in clinical rounds and conferences
Creates in depth documentation through written progress notes and dictations summaries
Maintains a high level of clinical competence in an area of specialty practice integrating the art and science of both nursing and medicine into practice
Independently assesses acute and non-acute clinical problems and toxicities
Performs and documents physical assessments and volunteer medical histories
Analyzes trends in patient conditions, and develops, documents, and implements a volunteer management plan in response to the data obtained
Serves as an associate investigator on protocols
Contributes to the implementation of specific protocols and the clinical management of volunteers on protocol
Collaborates with other disciplines in the obtaining and maintaining of informed consent/assent of volunteers on research protocols and prior to implementing invasive procedures
Interviews and screens volunteers for entry onto protocols
Monitors, documents, and communicates findings to Principal Investigators with recommendations for appropriate intervention
Uses advanced communication skills to problem solve complex situations and improve processes and services for volunteers and colleagues
Recognizes and reports adverse events/serious adverse events to study coordinators, Principal Investigators, FDA, and sponsors
Performs study procedures, as outlined in the protocols and within state and institutional scope of practice
Attends continuing education, research and training seminars as requested by management
Other duties as assigned