Clinical Research Psychiatric Registered Nurse

About the role

Alcanza is a growing multi-site, multi-phase clinical research company with a network of locations across AL, AZ, FL, GA, IL, MA, MI, MO, NV, VA, SC, TN, TX, and Puerto Rico. We specialize in Phase I-IV studies across therapeutic areas including vaccine, neurology, dermatology, psychiatry, and general medicine. The Clinical Research Nurse ensures the execution of assigned studies and performs clinical procedures under the scope of the study protocol in compliance with GCP, ICH, HIPAA, FDA regulations, and SOPs.

Responsibilities

• Collaborate with the clinical research site team to ensure the execution of assigned studies.
• Conduct study-related activities under the direction of the Site Manager/Director and Principal/Sub Investigators, including:
  • Screening patients for study enrollment and obtaining patient consents.
  • Conducting patient follow-up visits and documenting in source clinic charts.
  • Entering data in EDC and answering queries.
  • Obtaining vital signs and ECGs.
  • Performing basic lab procedures per protocol, such as blood specimen collection, centrifuge operation, storing and shipping lab specimens, and specimen accountability.
  • Performing procedures commensurate with licensure, including venipunctures, injections, infusions, and mixing/dispensing investigational products.
  • Requesting and tracking medical records.
  • Updating and maintaining logs and chart filings.
  • Maintaining and ordering study-specific supplies.
  • Scheduling subjects for study visits and conducting appointment reminders.
  • Building/updating source documentation as needed.
  • Conducting monitoring visits and resolving issues in a timely manner.
  • Ensuring study-related reports and patient results are reviewed by the investigator promptly.
  • Filing SAE/Deviation reports to Sponsor and IRB as needed.
  • Documenting and reporting adverse events and non-compliance.
• Maintain positive and effective communication with clients and team members.
• Adhere to ALCOAC principles in all documentation.
• Be thoroughly familiar with the protocol, case report form, informed consent, source documentation, patient diary, and study medication(s).
• Complete all needed activities for study start-up, including required training and preparing study files.
• Prepare for and attend site initiation visits (SIVs) and Investigator Meetings (IMs) as needed.
• Set up, train, and maintain all technology needed for studies.
• Assist with study recruitment, patient enrollment, and tracking as needed.
• Maintain confidentiality of patients, customers, and company information in compliance with HIPAA guidelines.
• Perform all other duties as requested or assigned.

Requirements

• A Bachelor’s degree in Nursing (BSN) and a minimum of 1 year of Psychiatric clinical experience, or an equivalent combination of education and experience.
• An active, unrestricted RN license in the state of work location.
• BLS certification required.
• Bi-lingual (English/Spanish) proficiency is a plus.

Skills

• Proficiency with computer applications such as Microsoft Office, email, electronic health records, and web applications.
• Ability to type proficiently (40+ WPM).
• Proficiency in performing clinical procedures such as injections, vitals, EKGs, phlebotomy, and infusions.
• Strong organizational skills and attention to detail.
• Well-developed written and verbal communication skills.
• Strong interpersonal and listening skills, with the ability to work well independently and collaboratively.
• Ability to handle multiple tasks, adapt to changes in workloads and priorities.
• Professional, respectful, self-motivated, and possessing a strong work ethic.
• High degree of integrity and dependability.
• Ability to work under minimal supervision, identify problems, and implement solutions.
• Ability to handle highly sensitive information confidentially and professionally, in compliance with HIPAA guidelines.

Benefits

Full-time employees regularly scheduled to work at least 30 hours per week are benefits-eligible, with coverage starting on the first day of the month following the date of hire.

• Medical, dental, and vision insurance.
• Life insurance and short/long-term disability insurance.
• Health savings accounts and supplemental insurances.
• 401k plan with a safe harbor match.