- Responsible for ensuring clinical trials are conducted according to signed investigator statement, protocol, Standard Operation Procedures (SOP's), good clinical practices (GCP's) and FDA regulations. Ensures subject safety throughout participation. Provides consultation to scientific staff and study sponsors in design, implementation, conduct, and reporting of research studies
- Reviews study protocol and attends study protocol initiation meetings.
- Obtains medical history of research subjects by interviewing.
- Performs physical exams according to study protocol and SOP's.
- Reviews laboratory values and charts to determine subject eligibility.
- Attends dosing of studies.
- Reviews adverse events and determines relationship of the event to the investigational drug.
- Supports activities related to clinical studies, including meeting with study sponsors, providing input to scientific staff on study design and identifying and developing additional capabilities that may lead to additional business opportunities.
- Reviews and completes case report forms.
- Oversees all staff involved in obtaining informed consent from potential participants.
- Available to provide medical advice and support in case of emergency or unanticipated serious incident.
- Develops good medical practices for all clinical staff to ensure company continues to provide the highest level of participant care and safety.
- Assures compliance to external regulatory agency standards.
- Compliance with GCP/GDP Principles.
- Other duties as assigned.
- Flexible day schedule (no over nights, but occasional early morning and late evenings).
- Must be available for weekend coverage.
- NP with current medical license and/or at least four (4) years related research/medical experience preferred. Minimum 1-year Clinical Research experience
- If non-medical (Ph.D., Pharm.D.) equivalent combination of education and experience with appropriate scientific degree.
- Current and valid state licensure.
- Current CPR certification.
- ACLS Certification is highly recommended for all medical investigators.
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Nurse Practitioner - Las Vegas, United States - Scientific Search
Description
Must be based in Las Vegas or willing to relocate to Las VegasCompany profile: An Early Phase CRO that specializes in Gastro, Dermatology, Allergy, Orthopedics and Women's Health.
What You Will Be Doing
#IND1