Overview:
Austin Clinical Trial Partners is seeking a motivated and detail-oriented Psychiatric Mental Health 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 on psychiatric disorders. 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 psychiatric 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 follow-up appointments with participants, administering psychiatric interventions, collecting biological samples, and performing clinical assessments in accordance with protocol requirements.
- Safety Monitoring: Monitor participant safety throughout psychiatric 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 cross-functional team members, including clinical research coordinators, data managers, and regulatory affairs personnel, to facilitate efficient study conduct and resolution of psychiatric research-related 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 protocol-specific training.
- Conduct pre-screens to select qualified prospective candidates based on specific inclusion/exclusion criteria, prohibited medications, protocol intensity, etc.
- Cross-screen by understanding inclusion and exclusion criteria of all active studies.
- Schedule qualified subjects for screening study visits.
- Demonstrate excellent relationship skills in order to develop long-lasting subject relationships.
- 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.
- Evaluate and screen potential subjects based on study eligibility criteria.
- 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 study-related documentation as required by the clinical research trial to ensure data integrity.
- Evaluate and report safety reports, protocol noncompliance, and any other protocol-specific reports.
- Follow requirements for FDA form 1572.
- 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 two years of experience as a Psychiatric Mental Health Nurse Practitioner and at least two years experience in clinical research or psychiatric clinical research trials.
- Knowledge: Strong understanding of psychiatric disorders, psychopharmacology, and clinical trial methodology
- Familiarity with Good Clinical Practice (GCP) guidelines and regulatory requirements specific to psychiatric research preferred.
- Communication Skills: Excellent verbal and written communication skills, with the ability to effectively communicate with study participants, investigators, sponsors, and regulatory authorities in the context of psychiatric research.
- Organizational Skills: Strong organizational and time management skills, with the ability to manage multiple tasks simultaneously and prioritize workload effectively in a fast-paced psychiatric research environment.
- Attention to Detail: Meticulous attention to detail and accuracy in data collection, documentation, and regulatory compliance, particularly in the context of psychiatric clinical trials.
- Team Player: Ability to work collaboratively within a multidisciplinary team, fostering a culture of teamwork, professionalism, and mutual respect in the context of psychiatric research.
- Computer Proficiency: Proficiency in Microsoft Office applications (Word, Excel, PowerPoint) and experience with electronic data capture (EDC) systems preferred.
Join our team and contribute to the advancement of mental health care through clinical research!
Job Type: Full-time
Pay: $75.00 - $85.00 per hour
Expected hours: 40 – 50 per week
Benefits:
- Dental insurance
- Flexible schedule
- Health insurance
- Paid time off
- Retirement plan
Work Location: In person
