Clinical Research Physician, Nephrology
Job at a glance
Job description
The PRN Sub-Investigator (Sub-I) plays a critical role in clinical research by supporting the Principal Investigator (PI) in the oversight and conduct of clinical trials. Depending on qualifications and site delegation, this role may also be eligible to be hired as either a Sub-I or a PI.
The primary duty of the Sub-I/PI is to protect human subjects and uphold their rights throughout the clinical trial. This role ensures that all delegated study activities are conducted in accordance with the protocol, Good Clinical Practice (GCP), and applicable federal regulations, while maintaining the integrity and validity of all data collected.
This role is part time and estimated be 10-15 hours a week on site in Hollywood, FL. MUST be a MD and will be seeing patients.
Job Responsibilities
-Completes required SOP training.
-Performs physical exams on research subjects.
-Performs study tasks delegated by the Principal Investigator (PI) with full involvement and oversight in accordance with protocol and regulatory requirements.
-Assists in recruitment for clinical trials; refer to other site trials.
-Conducts proper informed consent process according to SOPs, ensuring the most current ICF version is used.
-Evaluates the eligibility of patients for inclusion into clinical trials.
-Collects medical and surgical history, concomitant medication use, and adverse event information.
-Documents source documents, inpatient activities, visit progress notes, and adverse events. Maintains accurate records throughout the study.
-Reviews lab results, provides clinical significance for any out-of-range or abnormal values, and signs off as appropriate.
-Evaluates appropriateness of patient inclusion into trials; order repeat labs if necessary, or screen-fail patients as needed. Counsels’ patients on seeking appropriate medical care when necessary.
-Reinforces study restrictions, diets, and study guidelines.
-Reviews and provides insight into impending CRFs, electronic CRFs, data clarification forms, and/or data queries.
-Reviews source documents, lab results, and procedures throughout the study.
-Assesses adverse events and drug reactions, thoroughly recording details, including the relationship to the study drug.
-Assists in reporting any serious adverse events (SAEs) to the PI.
-Participates in monthly staff meetings.
-Reads and understands the information in the Investigator's Brochure (IB), including the potential risks and side effects of the drug.
Qualifications
• Ability to be credentialed with Davita and Fresenius dialysis centers
• Sub-I or PI experience required
• Spanish bilingual preferred
Working Hours