About The Position

Alcanza is a growing multi-site, multi-phase clinical research company with locations across multiple states and Puerto Rico and established experience in Phase I-IV studies across areas including vaccine, neurology, dermatology, psychiatry, and general medicine. The Clinical Rater interviews research participants and their informants or caregivers as part of their evaluation for research studies involving various health conditions. The position performs these activities in compliance with study protocols, standard operating procedures, Good Clinical Practice, ICH, FDA regulations, and privacy guidelines. This is a part-time, PRN role based in Decatur, Georgia, with approximately three days of work per week and morning availability needed.

Requirements

  • A master’s degree and at least one year of experience performing psychometric rating scales in a clinical setting or for clinical trials, or an equivalent combination of education and experience.
  • Proficiency with Microsoft applications, email, electronic health records, and web applications.
  • Ability to type at least 40 words per minute.
  • Strong organizational skills and attention to detail.
  • Well-developed written and verbal communication skills.
  • Well-developed interpersonal and listening skills, and ability to work independently and with coworkers, subjects, managers, and external customers.
  • Ability to handle multiple tasks and adapt to changes in workload and priorities.
  • Professionalism, respect for others, self-motivation, and a strong work ethic.
  • High degree of integrity and dependability.
  • Ability to work under minimal supervision, identify problems, and implement solutions.
  • Ability to handle sensitive information confidentially and professionally in compliance with HIPAA guidelines.
  • Morning availability and approximately three days per week.

Nice To Haves

  • Current or previous certifications to rate one or more of the following scales: SCID-5-CT, MINI, LSAS, HAM-A/D, C-SSRS, MADRS, MGH-ATRQ, ISI, CGI, HDRS-17, PANSS, YMRS, ADAS-Cog, CDR, MMSE, RBANS, or MOCA.
  • Bilingual English/Spanish proficiency.
  • BLS certification.

Responsibilities

  • Review subjects’ medical histories, meet with potential subjects, conduct prescreening interviews, and discuss study eligibility criteria with the Study team.
  • Conduct psychometric rating scales for clinical trial participants with a variety of diagnoses in accordance with study protocols, FDA regulations, GCP, ICH, and privacy guidelines.
  • Respond appropriately to potential risks of harm to subjects or others identified during evaluations to help ensure subject safety.
  • Calculate and use rating scale results as appropriate to determine protocol eligibility.
  • Meet with sponsors, study monitors, and medical monitors as needed to address questions about ratings.
  • Maintain consistency and efficacy in ratings by reviewing ratings across studies and subjects.
  • Maintain source documentation according to ALCOA-C standards and complete monitor and sponsor queries.
  • Complete sponsor-assigned training and meetings required for rater certification and recertification under study protocols.
  • Attend and successfully complete company training programs and participate in webinars and study meetings as needed.
  • Maintain confidentiality of subject, customer, and company information.
  • Perform other duties as requested or assigned.

Benefits

  • Benefits eligibility for full-time employees regularly scheduled to work at least 30 hours per week, with coverage beginning on the first day of the month following the date of hire.
  • Medical, dental, and vision insurance.
  • Life insurance.
  • Short- and long-term disability insurance.
  • Health savings accounts.
  • Supplemental insurance.
  • 401(k) plan with a safe harbor match.
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