What are the responsibilities and job description for the Nurse Practitioner - Clinical Research position at Actalent?
JOB DESCRIPTION
The Sub Investigator (Nurse Practitioner) has responsibility for the clinical safety of the patients partaking in the clinical trial, collecting, and recording accurate clinical data while also ensuring that the well-being and interests of the subjects enrolled in the studies are being met. The SI provides essential clinical support to the Center Managers, Coordinators, Principal Investigators, and other clinical trials staff.
RESPONSIBILITIES
- Perform the clinical study in accordance with ICH GCP, ensuring that adequate time and resources are available, as described in the trials’ protocols
- Clinically evaluate study participants, answer their medical questions, and resolve medical issues, related to the clinical trial during study visits
- Maintain records of each subject’s participation, which includes a review of participants’ past and current medical records, to be compared with visit medical history, concomitant medication and protocol inclusion and exclusion criteria
- Determine participant’s eligibility for the study
- Assessment of subject response to therapy and subject compliance with use of the study drug at follow-up visits
- Administration of in-site study drug, including IV drugs, SC drugs and oral medications
- Clinical evaluation and treatment of subjects for adverse events and reporting of all such events to the PI or study coordinator, according to protocol
- Ensure medical care is provided (or made available) to subjects for any treatable adverse event
- Monitor use of concomitant therapy as authorized by the study protocol
- Ensure that study drugs and devices are used for protocol purposes only
- Provide leadership in identifying new clinical trials and assist in initiation of new trials
- Play an active role in the doctor-led recruitment of patients to designated studies, while ensuring that subject recruitment is conducted ethically and efficiently
- Participate in pre-screening recruitment initiatives and activities for clinical trials participants, including presentations to healthcare professionals, public screening clinics, etc, as required.
- Comprehensive understanding of the informed consent process and protocol so that proper written informed consent from each subject is received prior to participation in the study
- Partake in Company Governance, FDA, Sponsor and CRO monitoring visits
- Completion of all administrative tasks for patient files according to GCP guidelines and best clinical practice
REQUIREMENTS
NP or PA, licensed to practice in Florida
Act in a professional and caring manner towards patients, visitors, and colleagues, projecting a high quality and high service experience
High ethical standards in line with company policies and procedures
Self-starter able to plan and prioritize own workload
Work collaboratively with colleagues to deliver services effectively and efficiently
Attention to detail
Safe handling of data and records regarding privacy and confidentiality, per HIPAA requirements
Excellent communication skills
About Actalent:
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Salary : $95,000 - $104,000
