Alcanza is a growing multi-site, multi-phase clinical research company with a network of locations in AL, AZ, FL, GA, IL, MA, MI, MO, NV, VA, SC, TN, TX and Puerto Rico. We have established a strong presence across Phase I-IV studies and several therapeutic areas including vaccine, neurology, dermatology, psychiatry, and general medicine. Join us as we continue to grow.
The Clinical Rater will be responsible for interviewing research participants and their informants/caregivers, who are being evaluated to participate in a research study for various health conditions, in compliance with study protocol, SOPs, GCP, ICH, and FDA Regulations.
The Clinical Rater will be responsible for interviewing research participants and their informants/caregivers, who are being evaluated to participate in a research study for various health conditions, in compliance with study protocol, SOPs, GCP, ICH, and FDA Regulations.
Essential Job Duties: Responsibilities may include but are not limited to:
- Reviewing the subject’s medical history, meeting with potential subjects, collecting information through a prescreening interview and discussing with the Study team criteria for eligibility for a particular study.
- Conducting a variety of psychometric rating scales on subjects with various diagnoses (such as ADHD, Alzheimer's Disease, Bipolar Disorder, GAD, Major Depressive Disorder, Post Traumatic Stress Disorder, Substance Use Disorders, and Schizophrenia/Schizoaffective Disorder) for our clinical trials, in compliance with specific study protocols, FDA, GCP, ICH, and privacy guidelines.
- Ensuring the subject’s safety by responding appropriately to any potential for harm to self or others that are identified through the evaluations performed.
- Calculating and utilizing rating scale results as appropriate to determine protocol eligibility.
- Meet with Sponsors, Study Monitors, and Medical Monitors as needed to address questions regarding ratings.
- Working diligently to maintain consistency in the performance of ratings. Reviewing ratings across studies and subjects to ensure efficacy and consistency.
- Maintaining source documentation in accordance with ALCOA-C standards and completing all monitor and sponsor queries.
- Completing all sponsor-assigned training and meetings to obtain rater certification and re-certification per protocols requirements.
- Attending and successfully completing all company training programs; participating in webinars and other study meetings as needed.
- Maintaining confidentiality of subjects, customers, and company information.
- Performing all other duties as requested or assigned.
Minimum Qualifications: A Master’s degree AND a 1+ years' experience performing psychometric rating scales in a clinical setting or for clinical trials, or an equivalent combination of education and experience is required. Current or previous certifications to rate the following scales is highly preferred: SCID-5-CT, MINI, LSAS, HAM-A/D, C-SSRS, MADRS, MGH-ATRQ, ISI, CGI, HDRS-17, PANSS, YMRS, ADAS-Cog, CDR, MMSE, ADAS-COG, CDR, RBANS, and MOCA. Bi-lingual (English / Spanish) proficiency is a plus. BLS certification is preferred.
Required Skills:
- Proficiency with computer applications such as Microsoft applications, email, electronic health records, and web applications, and the ability to type proficiently (40+ wpm);
- Strong organizational skills and attention to detail.
- Well-developed written and verbal communication skills.
- Well-developed interpersonal and listening skills and the ability to work well independently as well as with co-workers, subjects, managers, and external customers.
- Ability to effectively handle multiple tasks, and adapt to changes in workloads and priorities.
- Must be professional, respectful of others, self-motivated, and have a strong work ethic.
- Must possess a high degree of integrity and dependability.
- Ability to work under minimal supervision, identify problems and implement solutions.
- Ability to handle highly sensitive information in a confidential and professional manner, and in compliance with HIPAA guidelines.
- 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 date of hire.
- Medical, dental, vision, life insurance, short and long-term disability insurance, health savings accounts, supplemental insurances, and a 401k plan with a safe harbor match are offered.