Sub-Investigator

Sub-Investigator (CRC)

The Sub-Investigator role at Johnson County Clin-Trials is crucial for ensuring the safe, ethical, and effective medical oversight of volunteers participating in clinical research studies. This position directly supports the Principal Investigator by conducting thorough medical evaluations, diligently managing volunteer health throughout their study participation, and ensuring strict adherence to all study protocols and regulatory requirements. Through expert clinical assessment, collaborative teamwork, and strong communication skills, the Sub-Investigator plays a vital role in maintaining high-quality research standards, safeguarding participant well-being, and contributing to the successful execution of clinical trials.

Position Summary

The Sub-Investigator is responsible for providing comprehensive medical evaluation and care to volunteers enrolled in research studies conducted by Johnson County Clin-Trials. This role is performed in close collaboration with the Primary Investigator and other members of the multidisciplinary health care team. The Sub-Investigator is tasked with screening new volunteers medically, managing them while they are actively participating in a study, and providing necessary follow-up care. These critical activities may take place in both in-patient and outpatient settings, involving the assessment of both acute and non-acute clinical problems and toxicities. Exceptional customer service is paramount in this role, as the Sub-Investigator engages directly with volunteers and various other departments.

Key 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 dictation summaries.
• Maintains a high level of clinical competence in a specialty practice area, integrating the art and science of both nursing and medicine.
• 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 obtaining and maintaining 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 the 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 and problem-solving skills.
• Self-motivated.
• Results-oriented, multi-tasking, quick learner.
• Complex problem-solving abilities.
• 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 ensure program or project goals and objectives are met.

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.

Why JCCT?

JCCT has provided exceptional customer service to clients, volunteers, and vendors for the last 20 years, earning recognition as one of the best clinical research sites in the United States. We are actively growing and seeking high-performing individuals to support our continued success. Clients worldwide choose JCCT for their research needs. We are proud of our accomplishments and invite you to explore career opportunities with us. JCCT is committed to supporting, accepting, and respecting you as an individual within our family-focused environment.

Our vision is to make a difference in the world by improving health and well-being through pharmaceutical research and drug development. Our impact is driven by genuine care, support, and customer service for our employees, volunteers, and sponsors.

If you are looking for a positive work environment with opportunities for personal growth and satisfaction, we encourage you to apply at JCCT. Qualified candidates will be contacted for interviews. Unleash your potential and apply today!

EEO Statement

JCCT provides equal employment opportunities (EEO) to all employees and applicants. We value diversity at our company and it is our policy to recruit, hire, and promote qualified individuals without regard to race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Key skills/competency

• Sub-Investigator
• Clinical Research
• Medical Oversight
• Protocol Adherence
• Volunteer Health Management
• Regulatory Compliance
• Good Clinical Practices (GCP)
• Nurse Practitioner
• Patient Assessment
• Adverse Event Reporting