Sub-Investigator

Johnson County Clintrials LLC•Houston, TX

About The Position

The Sub-Investigator (CRC) role is crucial for ensuring the safe, ethical, and effective medical oversight of volunteers 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. The Sub-Investigator screens new volunteers medically, manages them during study participation, and provides follow-up care as needed, in both in-patient and outpatient settings. This includes assessing acute and non-acute clinical problems and toxicities. Customer service is critical 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 met

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