Nurse Practitioner - West Palm Beach, United States - Comprehensive Clinical Research

Description

We are seeking a motivated and detail-oriented Nurse Practitioner to join our clinical trials practice as a Sub-Investigator. In this role, you will collaborate closely with the Principal Investigator and research team to conduct clinical trials focused onmany indications. This is an exciting opportunity to leverage your clinical expertise to contribute to the advancement of medical science and improve patient outcomes through innovative research initiatives in mental health.


Duties and Responsibilities:

• Study Protocol Implementation: Assist the Principal Investigator in implementing clinical trial protocols, ensuring adherence to study procedures, timelines, and regulatory requirements specific to psychiatric trials.
• Participant Recruitment: Screen and enroll eligible participants into clinical trials, utilizing effective recruitment strategies to meet enrollment targets while ensuring compliance with study protocols and inclusion/exclusion criteria.
• Informed Consent Process: Conduct informed consent procedures with potential study participants, ensuring thorough comprehension of study procedures, risks, and benefits related to psychiatric interventions.
• Clinical Assessments: Perform comprehensive psychiatric assessments, including mental status examinations and diagnostic evaluations, as required by study protocols. Accurately document participant data in case report forms (CRFs) and electronic data capture (EDC) systems.
• Study Visits: Conduct study visits and followup appointments with participants, administering psychiatric interventions, collecting biological samples, and performing clinical assessments in accordance with protocol requirements.
• Safety Monitoring: Monitor participant safety throughout clinical trials, promptly reporting adverse events and serious adverse events to the Principal Investigator and regulatory authorities as per protocol and regulatory guidelines.
• Data Management: Ensure accurate and timely completion of study documentation, including CRFs, source documents, and regulatory submissions, maintaining compliance with Good Clinical Practice (GCP) guidelines and applicable regulations specific to psychiatric research.
• Quality Assurance: Assist in implementing quality assurance and quality control measures to ensure data integrity, protocol compliance, and participant safety throughout the conduct of psychiatric clinical trials.
• Collaboration: Collaborate with crossfunctional team members, including clinical research coordinators, data managers, and regulatory affairs personnel, to facilitate efficient study conduct and resolution of psychiatric researchrelated issues.
• Complete required institutional and protocol specific training.
• Adhere to the federal regulations, state and local laws, institutional policies and procedures surrounding the safety and protection of human participants.
• Ensure participant privacy and confidentiality according to HIPAA guidelines, institutional regulations, and HRPO policies and procedures.
• Update appropriate documents and databases; achieve 100% compliance with all SOPs.
• Attend webinars, teleconferences, meetings, and study protocol trainings to further learn about the field and specific research studies.
• Maintain a current GCP Certification and be compliant with IRB, GCP, and HIPAA guidelines.
• Complete required institutional and protocolspecific training.
• Crossscreen by understanding inclusion and exclusion criteria of all active studies.
• Provide oversight and ensure proper delegation of duties to appropriate qualified staff.
• Provide Sponsor and IRB with documentation of credentials as required.
• Maintain all required licenses to practice and trainings required to execute the job as a Sub-I.
• Assume responsibility as the Sub-Investigator for the duration of clinical trials.
• Demonstrate the proper education, training, and experience to conduct the clinical investigation.
• Disclose conflicts of interest as described in the regulations.
• Perform and review assessments performed by raters in accordance with the clinical study protocol.
• Complete all documentation, paper and electronic, as required per protocol.
• Provide and maintain updated studyrelated documentation as required by the clinical research trial to ensure data integrity.
• Evaluate and report safety reports, protocol noncompliance, and any other protocolspecific reports.
• Follow requirements for FDA form 157
• Collaborate with operational and management team to ensure site goals are met.
• Travel to Investigator, educational, and business development meetings as needed.
• Diversity and bilingual capabilities are desirable.

Qualifications:

• Education: APRN (Advanced Practice Registered Nurse). Current nursing licensure in good standing (Nurse Practitioner)
• Experience: Minimum of one year of experience as a Nurse Practitioner and at least one year experience in clinical research preferred but not required
• Familiarity wi