Salary Range: 0 to 350000 (Currency: USD) (Pay period: per-year-salary)

Duties and Responsibilities:

• Provide overall medical direction and medical review of protocols in conformance with the investigational plan and good clinical practice.
• Provide medical and scientific feasibility assessments for all new sponsor inquiries.
• Ensure that the safety and well-being of all participants in the study at the trial site are protected.
• Ensure data collected at the study site is credible and accurate.
• Ensure the rights, integrity, and confidentiality of all participants in the trial at the site are protected.
• Participate in monitoring visits and sponsor meetings; allow monitoring and auditing by sponsors and inspection by appropriate regulatory agencies.
• Perform physical assessments and study procedures.
• Review participants’ medical history.
• Administer Investigational Products.
• Review and adhere to the study protocol.
• Be thoroughly familiar with the appropriate use of the investigational product (study drug) as described in the protocol and Investigator’s brochure/product monograph and other documents provided by the sponsor.
• Ensure accuracy, completeness, legibility, and timeliness of data reported on the CRF (case report form) and be consistent with source documents.
• Ensure participants are informed and receive appropriate therapy and follow-up if the trial is prematurely terminated or suspended for any reason.
• Immediately report Serious Adverse Events (SAEs) or any abnormalities affecting participants’ safety to sponsors and the IRB as per specific reporting guidelines.
• Maintain proper documentation.
• Ensure that the study, consent, and other documents provided to the subjects are approved by the IRB and comply with GCP and other regulatory requirements.
• Maintain trial documents specified by the Essential Documents section of the ICH guidelines and as required by applicable regulatory requirements.
• Provide access to research-related records to monitors, auditors, representatives of the IRB, and regulatory authorities.

Required Skills and Abilities:

• Excellent verbal and written communication skills.
• Excellent organizational skills and attention to detail.
• Excellent time management skills with a proven ability to meet deadlines.
• Strong analytical and problem-solving skills.
• Strong supervisory and leadership skills.
• Ability to prioritize tasks and delegate them when appropriate.
• Ability to function well in a high-paced environment.

Education and Experience:

• Medical degree (MD or DO) with board certification in Internal Medicine or Family Medicine.
• Active medical license in California.
• Clinical research experience is required with a minimum of 10 completed studies.