The Nurse Practitioner (NP) fulfills the role of the Sub-Investigator (Sub-I) in ensuring that the protocol is conducted to plan and to all applicable Federal Regulations. Required to assist the Principal Investigator (PI) in the daily running of Clinical trials by performing a variety of duties involved in the management, oversight of data, patients, and clinical research staff.
ESSENTIAL JOB FUNCTIONS
1. Responsible for protecting the rights, safety, and welfare of all subjects under the investigator’s care
2. Provide both emergent and non-emergent Medical Care: When in the facility you will respond with the Emergency Response Team when a code is called.
3. Assist the PI in the control of study drugs under investigation
4. Assist the PI the control of non-study drugs within the facility
5. Explain in detail informed consents forms to potential patients: Administer consent per site SOP guidelines
6. Thoroughly understand all assigned protocols and study procedures
7. Under PI guidance discuss any medical or protocol and study procedures
8. Responsible for performing procedures such as, but not limited to: dosing supervision, check-in and check-outs, Physical Exams, Review all safety labs and EKG’s, AE and SAE assessments.
9. Reports directly to the Associate Medical Director.
1. Follow established SOPs for the oversight and management of data collection, patient safety, and clinical research staff
2. Provide oversight of all studies to ensure protocol driven direction and completion
3. Promote a positive team-oriented interaction between departments.
1. Assist the PI in ensuring staff has adequate training and understanding of the clinical trial and study procedures to complete the trial correctly.
Personal and Staff Development/External Relationships
1. Attend the external trainings sessions/seminars for personal development
2. Inform/educate/implement management policies.
1. On-call for any safety related events if after hours/weekends
2. Participate in pre-study meetings, initiations, and Investigator meetings (as needed)
3. Participate in developing recruitment goals and strategies
4. Required to fulfill the role of a NP or PA as needed.
Knowledge of the Microsoft Office Suite - A proficient user of Microsoft Office Applications including PowerPoint, Word, Excel, Outlook, Project
Knowledge of other computer programs – SharePoint
Knowledge and use Multi-lined Call Center Tools - A proficient user of Call Center Customer Relations Management (CRM) tools, and ability to interpret reports and data from CRM
EDUCATION, CERTIFICATES, LICENSES AND TRAINING
1. Current California license as a NP/PA
2. Current American Heart Association Basic Life Support Certification required
3. Current American Heart Association Advanced Cardiac Life Support (ACLS) Certification required.
4. Current American Heart Association Pediatric Advanced Life Support (PALS) strongly recommended.
1. Experience as a clinical investigator is preferred
2. Ability to critically review and interpret safety data
3. Strong leadership skills and ability to function in an interdisciplinary team are essential
4. Excellent communication, organizational and interpersonal skills and attention to detail
PHYSICAL REQUIREMENTS AND WORK ENVIRONMENT
The description of the physical demands and the work environment characteristics here represent those that must be met by an employee to successfully perform and those an employee encounters while performing the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job:
Ability to talk or hear.
Required to sit 90% of the workday.
Occasionally required to stand; walk.
Must be able to use hands to finger, handle, or feel; reach with hands and arms.
Minimal lifting is required, 10 pounds, with assistance and/or move up to 50 pounds.
Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus when viewing a computer monitor.
While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, fumes or airborne particles, toxic or caustic chemicals and risk of electrical shock.
The noise level in the work environment is usually low.