Title: Clinical Rater

Location: Choose an item.

Job Description:

ERG is a leading U.S. based, privately held, independent clinical research site company, and provider of clinical development services with an expertise in early and late stage neuroscience drug development. With 22 wholly owned clinical sites and 5 affiliated sites, we conduct in-patient and out-patient phase I-IV clinical research studies. ERG has 340+ in-patient beds, a large and growing database of patients suffering from mental illness, neurological disorders, sleep disorders, addictions, Acute and Chronic Pain, diabetes and other illnesses as well as normal healthy volunteers who participate in trials for the advancement of medicine. With access to over 32 million patients/subjects and 5000 + completed trials, ERG continues to grow its capabilities and expand into indications where there are tremendous unmet medical needs in the United States and globally.

The Clinical Rater is responsible for the organization, administration, management, and efficient execution of clinical ratings associated with clinical trials. Completes all responsibilities under the direction of the Principal Investigator and the Site Director and maintains accurate and confidential documentation of study participants. In executing these responsibilities, the Rater is guided by FDA regulations, Good Clinical Practice (GCP), relevant workplace practices, and company standard operating procedures.

Responsibilities:

General

• Ensure applicable license is current and valid.
• Obtains detailed knowledge of all components of a study protocol relevant to completion of rating scales through review and analysis of study information with Principal Investigator and Site Director prior to the effective date of the study.
• Reviews with Principal Investigator and Site Director, any components of the study for which additional information or clarification are required prior to the initiation of the study.
• Manages aspects of the study related to ratings with the rater training representative, study sponsor, Site Director, and Principal Investigator to ensure compliance with protocol requirements.
• Assist in recruitment efforts as directed by PI or Site Director
• Collect demographic, medical, psychiatric, and medication history during prescreening interviews for the purpose of determining eligibility for clinical trial participation
• Obtaining and documenting subject consent using the prescreen informed consent.
• Serves as a mentor and trainer for new raters once approved to do so by the Site Director and/or PI.
• Contribute to related SOP review and development as delegated by the Site Director.

Study Management

• Perform study activities as delegated by the Principal Investigator and under the supervision of the Site Director.
• Attends the investigator meeting for each assigned protocol, as appropriate.
• Completes all rater documents, trainings, assessments, and certification as required.
• Ensure all rating assessment are conducted in adherence to the protocols and notifies relevant staff when there are any breaches.
• Maintain organized, accurate and complete study records.
• Collect data as appropriate for protocol (paper and/or electronic data capture)
• Store study records and materials appropriately

Skills and Qualifications:

• Education and experience
  • Bachelor’s, RN, or master’s degree required; PhD preferred.
  • Rater experience required
• Requirements
  • Understands regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines.
  • Able to communicate with providers, co-workers, sponsors, and others in a collaborative and courteous manner.
  • Knowledgeable in medical and/or psychological terminology to communicate with physician office and staff.
  • Demonstrates the initiative to act independently, initiating activity as required and making appropriate decisions within the constraints of study protocols, regulatory requirements, and company policy.
  • Able to initiate or modify behavior to achieve desired outcomes despite environmental factors, priorities, or problems that might not be well defined or that are subject to change.
  • Excellent communication skills (interpersonal, written, verbal)
  • Basic computer skills to include Word, Excel, as well as proprietary applications unique to the clinical research industry (such as Study Manager)