Clinician/ Medical Monitor
|Department Name:||G&A - Li|
|Position Type:||Full Time|
|Position Title||Clinician/ Medical Monitor|
|Position Summary:|| |
The Medical Monitor will be accountable for providing oversight and medical expertise for clinical trials and to ensure patient safety. S/he serves as the single point of contact for monitoring, coding of events, safety reporting and dissemination of trial safety data, and interfacing with clinical investigators on the medical management of clinical trial subjects. The Medical Monitor is responsible for providing safety oversight and for reviewing the protocol and information about the study investigation product as it becomes available, such as the Investigational Brochure (IB), and reported safety events including SAE narratives, SUSARs and communicating with sites if new information emerges. In consultation with the CMO, the protocol team and clinical review committees (or Data Safety Monitoring Boards), will provide safety review during the execution of the clinical trial.
|Position Description|| |
· Provides input into medical risk factors, serious adverse event reports, medical history and other important information for benefit-risk evaluation.
· Leads and participates in the internal clinical review committee meetings.
· Participates on the data safety review board meeting when instituted for a clinical trial.
· Reviews literature as needed to respond to safety questions for those involved in the studies including but not limited to the clinical/data review boards and IRBs/IECs.
· Ensures the protocol, investigator brochure and informed consent documents meet regulatory requirements.
· Ensures high quality of collected safety data.
· Conducts medical review and interpretation of safety and efficacy data in collaboration with other functional lines (internal or external to Calibr).
· Interfaces with contract research organizations’ pharmacovigilance groups.
· Provides protocol specific training to study team, investigators, members of the CRO team and others.
· Authors clinical sections of regulatory documents.
|Location:||San Diego, California|
|Physical Requirements:|| |
This position works in a typical office environment. With or without reasonable accommodation, employees in this position must be able to sit and type at a computer terminal for up to 8 hours per day with appropriate breaks and perform tasks that require fine dexterity and repetitive motions using the arms, hands, wrists and fingers. Further details of the physical requirements of established essential functions for this position will be addressed/discussed during the interview process. Frequent travel to clinical sites required.
|Basic Qualifications:|| |
· MD Required.
· Specialization in Oncology or related field.
· 5-10 years direct experience in the pharmaceutical industry, preferably in a medical monitoring role.
· Understanding of drug safety regulations and processes and clinical trial oversight.
· Experience providing input into key regulatory documentation.
· Excellent interpersonal and communication skills with ability to relate to both internal and external stakeholders.
· Strong communication and presentation skills as well as an ability to communicate clearly and concisely in writing.
· Experience presenting to a wide variety of audiences including internal teams and medical/scientific communities.
|Job Closing Date:|
|Open Until Filled||Yes|
|Job Posting Category||Scientific & Technical|
|EEO Statement|| |
The Scripps Research Institute is an Equal Opportunity Employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other legally protected characteristic or status.