Sub-Investigator
On-site · Houston, Texas, United States
Job Summary
Sub-Investigator provides medical evaluation and care to volunteers enrolled in clinical studies, working with the Primary Investigator and health-care team. Responsibilities include screening volunteers, medical management during studies, follow-up care, and documentation; conducting physical assessments and histories; interpreting diagnostic data; managing medications for volunteers; participating in clinical rounds, education of volunteers and staff; ensuring adherence to study protocols, regulatory requirements, informed consent, and adverse-event reporting; collaborating with disciplines to maintain high-quality trial conduct and safety.
Required Qualifications
- 5 years of previous clinical research experience working directly with clinicians/providers
- 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
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