The Physician will fulfill the role of Principal Investigator (PI) or Sub-Investigator (Sub-I) as the study dictates. The position is responsible for ensuring that the protocol is conducted to plan and according to all applicable regulations. The Physician will conduct clinical trials and provide oversight of subjects, clinical research staff and the management of data.
ESSENTIAL JOB FUNCTIONS
1. Responsible for protecting the rights, safety, and welfare of all Subjects.
2. Provide both emergent and non-emergent medical care to subjects:
- Assess Adverse Events and Serious Adverse Events as needed
- When in the facility, the Physician will respond with the Emergency Response Team when a code is called
3. Administer the Informed Consent process to potential Subjects per site SOP guidelines
4. As a Principal Investigator the additional duties and responsibilities are required:
Attend meetings related to the study, such as but not limited to:
- Pre-study Meetings, Site Initiation Visits, and Investigator meetings.
- Dose Strategy Meetings
- Source Review Meeting
- Safety Review/Dose Escalation Meetings
- Monitor/Sponsor meetings and Close-Out Visit Meetings
Review and thoroughly understand all assigned protocols and study procedures
- Create a protocol synopsis with key relevant details of the protocol
Provide training on all assigned protocols and study procedures. Training consists of but is not limited to:
- Post-SIV Training
- Dosing Training
Sign-off on the Delegation of Authority Log and delegating only those staff that are qualified and appropriately trained on the protocol
Provide guidance to staff/recruitment and answer any protocol-related enrollment issues.
Responsible for discussing any medical or protocol-related issues with the medical monitor.
Sign-off on any protocol deviations and Note-To-Files.
Responsible for performing procedures such as, but not limited to:
- Being present for initial dosing
- Conducting Physical Exams
- Reviewing labs and EKGs
- Assessing out of range vitals
- Assessing AEs and SAE
- Performing call-backs/follow-ups for any safety issues/reporting diseases to the appropriate agencies, etc.
- Confirming subject’s eligibility prior to enrollment into the study
- Ensuring subjects continue to meet eligibility throughout the study.
Responsible for the control of investigational product
Responsible for signing off on the eCRF’s
5. As a Sub-Investigator the additional duties and responsibilities are required: Assist the PI in the control of investigational product, thoroughly understand all assigned protocols and study procedures.
6. Responsible for performing procedures such as, but not limited to: Being present for dosing, Conducting physical exams, Reviewing labs and EKGs, Assessing AEs and SAEs, Performing call-backs/follow-ups for any safety issues/reporting diseases to the appropriate agencies, etc.
7. The Sub-Investigator, under the guidance of the PI, will discuss any medical or protocol-related issues with the medical monitor
8. Assist the PI in ensuring staff has adequate training and understanding of the clinical trial and study procedures to conduct the trial according to the protocol.
9. Participate in pre-study meetings, initiations, and Investigator meetings (as needed)
10. Serve as interim PI when the assigned PI is out of office.
11. Reports directly to the Medical Director.
QUALIFICATIONS AND REQUIREMENTS
- Exhibits sound and accurate judgment and logical reasoning
- Promote a positive, team-orientated, interaction between departments
- Positive role model; exhibits confidence in self and others
- 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
- Customer focus - Understanding the needs of the internal or external customer and keeping them in mind when taking actions or making decisions.
- Team player - Effective participant as a team member and team leader. Can demonstrate significant positive participation on successful teams.
- Professionalism and integrity - Exhibits professionalism in negotiating sensitive issues.
- Problem solving techniques - Able to adapt to a changing environment and demonstrates a “make it happen” attitude.
- Interpersonal interaction - Demonstrates excellent people skills and a positive attitude.
- Communication - Effective verbal communication and presentation skills. Ability to write clear, succinct and convincing memos, letters and articles using original or innovative techniques or style.
- Organization - Ability to prioritize and to manage multiple tasks as necessary.
- Attention to detail - Produces high-quality, accurate work with minimal supervision.
- Flexibility - Ability to adapt and be willing to assist with achieving Company goals in the area of responsibility and time.
EDUCATION, CERTIFICATES, LICENSES AND TRAINING
- Current California License as a MD/DO
- Current American Heart Association Basic Life Support (BLS) Certification required
- Current American Heart Association Advanced Cardiac Life Support (ACLS) Certification required.
- Current American Heart Association Pediatric Advanced Life Support (PALS) Certification strongly recommended.
- Board Certification recommended
- Experience as a Clinical Investigator is preferred.
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.
1. 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.