About this position
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.
Duties and Responsibilities:
- Attends Site Initiation Visits and/or training in-service for all current protocols.
- 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.
- Provides guidance to the clinical team as needed.
- Assists in the training of support staff for the clinical trials under supervision.
- Assists in recruitment for clinical trials; refer to other site trials.
- Sets schedule to accommodate patients onsite and/or offsite as necessary. This may include weekends and holidays.
- 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.
- Performs Clinical Research Coordinator duties.
- Occasional travel to Company sites, Investigator meetings, and/or Company meetings.
- Performs other miscellaneous job-related duties as assigned by your manager.
This job description is not an exhaustive list of all the functions that you may be required to perform. The Company reserves the right to revise this job description at any time.
Requirements:
- A qualified Nephrologist in the relevant field of health care (MD)
- Must be credentialed with Davita and Fresenius Kidney Centers.
- Minimum of 3 years’ experience in clinical research (preferred)
- In-depth knowledge of federal regulations regarding responsibilities of a Primary or Sub- Investigator. The Investigator is deemed competent when he/she can thoroughly manage project,read and understand the available information (IB) on the product under investigation, including the potential risks and side effects of the drug and possesses the ability to adhere to the study protocol and investigate the drug under investigation.
Competency Requirements:
- Excellent communication skills.
- Problem-solving skills.
- Planning/organizational skills.
- Customer service skills.
- Attention to detail and ability to follow clinical research protocols.
- Ability to work collaboratively with a multidisciplinary research team.
- Strong analytical and critical thinking skills.
- Adaptability to a fast-paced research environment.
- In depth knowledge of FDA-GCP regulations pertaining to protecting human rights and safety, ethical issues and clinical assessments when dealing with clinical research and human volunteers.
Physical Requirements and Environmental Factors:
- Approximately 20% travel required.
- Mid-level computer use
- Work is normally performed in a typical interior clinical/office environment.
- Prolonged periods of sitting at a desk and working on a computer.
- Lifting of 20 pounds and occasionally more than 20 pounds.