Job Type

Full-time

Description

Sub-Investigator (CRC)

Purpose:

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.

Position Summary:

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.

Key Responsibilities (Essential Functions):

• 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

Education and Experience:

• 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

Skills and Competencies:

• 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

Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• 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

Salary Description

$52.00 per hour