Clinical Research Physician

Job Description:    Clinical Research Physician (Sansum Diabetes Research Institute)

Department:          Clinical Research

Reports to:             Chief Scientific Officer

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Conduct clinical trials as principal or co-investigator in accordance with investigator agreements, all requirements of the investigational plan, IDE/IND regulations, other applicable regulations of the FDA and any conditions of the reviewing Institutional Review Board, by ensuring patient safety, data integrity and regulatory compliance.
• Abide by all of the responsibilities of the Investigator addressed under FDA 21 CFR.
• Comply with Good Clinical Practice (GCP)/International Committee on Harmonization Guidelines (ICH) and other applicable regulatory requirements.
• The clinical investigator is responsible for overall conduct of the study at the clinical site, including directing the administration or dispensing of the investigational product to the subject and ensuring that data are collected and maintained in accordance with the protocol and applicable regulatory requirements.
• Ensure appropriate medical monitoring of study participants, which include:
• Performing medical evaluations (history and physical examination and review of laboratory tests and EKGs, etc.),
• Participate in on-call functions as needed,
• Provide medical management if needed and cannot be provided in a timely fashion by the participants physician,
• Maintain communication with the participants’ primary physician as appropriate.
• Address medical concerns raised by the sponsor, IRB or the FDA that relate to a specific clinical trial
• Permit monitoring and auditing by sponsor and inspection by the appropriate regulatory authorities.
• Complete and review SAE reports for the sponsor, IRB and possibly to the FDA to verify accuracy and submit within 24 hours to sponsor and IRB.
• Provide support and oversight to delegated research staff, including co-investigators, nurse practitioners, nurses, research coordinators and any other delegated individual.
• Complete and review source documentation as well as review completed CRFs and sign off on the completion forms.
• Participate in investigator-initiated protocols and facilitate the implementation of such protocols.
• Clinical care based upon interest.

SUPERVISORY RESPONSIBILITIES:

TBD based on candidate

Per FDA’s 21 CFR, when the investigation is conducted by a team of individuals, the clinical investigator is the responsible leader of the team and may delegate qualified staff

 HOURS OF WORK:

Work hours will be flexible to meet project needs. Early mornings, evening and weekend work may be required.

WORK ENVIRONMENT:

 The primary work environment would be generally described as a clinical setting with offices adjacent to the primary work area and laboratory facilities on a different floor. The ability to move within all three of these areas may be required in the execution of the employee’s functional activities. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually low and the illumination of the work area is primarily with fluorescent artificial lighting.

This position is associated with exposure to biohazardous materials and communicable disease requiring the use of universal precautions at all times as well as other conditions common to a medical clinic and research facility.

PHYSICAL DEMANDS:

The incumbent is regularly required to sit, talk, hear, and climb stairs. The incumbent frequently is required to use hands to finger, handle or feel equipment, paper, or files. The incumbent must be able to operate a computer keyboard as well as see a computer monitor display screen. The incumbent is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 10-20 pounds. Specific vision abilities required by this job include close vision.

This job requires the manual dexterity, skill level and adequate vision to perform physical examinations, phlebotomy, record data onto data sheets, and enter data into a computer; adequate hearing and verbal communication skills to conduct interviews (in person or on the telephone).  Standing for extended periods of time as well as light lifting is necessary.  Moderate use of a computer and telephone. 

The incumbent must be in sufficient overall health to report for work consistently and reliably and work through a standard day with appropriate breaks. Periodically, extended work hours and travel extending over several days are required.  

QUALIFICATIONS:

• The successful candidate should have experience in the conduct of clinical trials (2+ years preferred) and the ability to work independently and with careful attention to detail.
• Current medical license in the State of California is required.
• Excellent oral and written communication skills.
• Current Good Clinical Practice certification, as well as other research related trainings and certifications are required to be maintained.
• Must be able to establish rapport and communicate with staff and clients of diverse cultural and educational backgrounds.

EDUCATION and/or EXPERIENCE:

Board-certified physician, licensed in the State of California

Training in internal medicine, pediatrics, or family practice, with a Sub specialization in Endocrinology preferred.

COMPENSATION:

Total compensation will be based on the candidate’s experience

Benefits include medical, dental, vision, 403B, paid holidays

Sansum Diabetes Research Institute is a nonprofit organization and is a qualified employer for the federal Public Service Loan Forgiveness Program (PSLF).