Nurse Practitioner/Sub Investigator
Meridian Clinical Research is looking for a full-time Nurse Practitioner (NP) to join our team of clinical research investigators, coordinators, and research assistants. Meridian Clinical Research partners with pharmaceutical and biotechnology companies to research new drugs, medical devices, and diagnostics that could improve human health and wellbeing.
The job of the NP or Sub Investigator (Sub-I) is to act as the secondary physician in medical and clinical issues, as requested or required. The Sub-I works with the PI to evaluate clinical trials and ensure that all study-related procedures are completed. The Sub-I performs critical trial-related procedures and makes important trial-related decisions. The Sub-I is engaged in the informed consent process and has a significant role in the conduct of the research.
· Ensure that an investigation is conducted according to the signed investigator statement, the investigational plan and the applicable regulations.
· Screen and recruit patients.
· Obtain informed consent of each human subject to whom the drug is administered in accordance with the provisions of Title 21 part 50except as provided in Title 21 part 50.23 and 50.24. Title 21 part 312.60.
· Confirm eligibility of study subjects.
· Sign prescriptions.
· Conduct clinical examinations.
· Evaluate laboratory and other medical reports.
· Supervise administration of study drug.
· Maintain accurate accountability for all clinical supplies received by site.
· Observe, measure and record effects of drug.
· Evaluate, manage and report all adverse events.
· Keep and make study documentation available for data verification purposes.
· Performs technical tasks, such as medical procedures, tests and assessments that require special experience.
· Assess study-specific procedures along with the clinical research coordinator required for each protocol and assign responsibility to specific staff.
· Participate actively in all phases of the research study including serious adverse event (SAE) reporting and advocates for all patients.
· Provide accurate history and physical examination to all research subjects at baseline including all the required phases for each study.
· Perform phlebotomy and process blood and urine samples.
· Process and package various infectious and non-infectious lab specimens.
· Work with the clinical research coordinator in provide in-service education on new protocols to study and hospital staff as needed.
· Responsible for study completion (study close-out).
· Send accurate screening logs to sponsor weekly.
· Oversee that coordinator is knowledgeable and educated on study drug administration.
· Assist in maintaining accurate accountability for all clinical supplies received by the site.
· Assist and educate staff on phlebotomy.
· Be available for any questions regarding closeout visit of study.
· Ensure accurate screening logs are sent to sponsor weekly coordinator.
· Performs other duties as assigned.
Meridian offers competitive pay and benefits, and rewards high performance with excellent career opportunities. If you’re ready to help advance human health while working in an enjoyable, fast-paced environment, contact Meridian.
- At least two years of clinical or medical experience.
- Ability to travel to other sites on occasion
- Valid and maintained Physician Assistant (PA) license or Advanced Practice Registered Nurse (APRN)/Nurse Practitioner (NP) license.
- Have high ethical standards and professional honesty.
- Friendly and outgoing demeanor.
- Demonstrate clinical competence, positive leadership and ability to work collaboratively with a multi-disciplinary team.
- Must demonstrate a passion for direct patient interaction.
- Familiar with the background of the study drug and requirements of the study.
Meridian not only strives to move science forward and improve the lives of others, but we focus on improving the lives of our people by offering a competitive benefits package to all full-time employees. Meridian's benefits package includes eligibility for medical insurance, dental insurance, vision insurance, 401k with company match, six paid holidays, paid time off, complimentary life insurance, disability insurance and so much more!