A Clinical Specialist, in collaboration with the Clinical Director and the Clinical Lead, will perform remediation activities with site raters, in relation to ongoing clinical trials. The Clinical Specialist may also assist in the organization and completion of didactic training slide sets, documents and other presentations for the rater audience as well as project sponsors. Other Clinical Specialist responsibilities may include: perform basic and in depth research on disease states and ratings scales, data monitoring, rater monitoring, functional assessments of rater performance and qualification, assist in preparing and disseminating rater communications, provide feedback and review of sponsor reports, and contact with sponsors or other outside scale experts.
Required Experience, Knowledge, Skills:
- Minimum of a Master’s degree (MA/MS) in Psychology, Counseling, Psychiatric Nursing or Social Work.
- Minimum of 3 years experience administering psychiatric assessments, ratings scales and/or Structured Clinical Interviews.
- Minimum of 3 years clinical experience with related psychiatric populations (psychosis and depression required)
- Bilingual a plus.
- Experience in central nervous system (CNS) trials a plus.
- Strong interpersonal skills with ability to interact with all levels of personnel and clientele in a professional manner.
- Excellent organization, attention to detail, time management and problem solving skills.
- Knowledge of or ability to understand, the client needs and project objectives.
- Computer proficiency including excellent skills in Windows with Microsoft Office system and applications, specifically, Excel, PowerPoint, Outlook and Word. Experience with SharePoint applications a plus.
- Opportunity to work from home as well as from the office.
- Participate in all orientation, training and calibration activities as required.
- Provide independent clinical analysis of case data and remedial action preparation.
- Complete case discussions as scheduled.
- Responsible for completion and timely submission of case detail and outcome reports.
- Participate and assist with the research, preparation and presentation of sponsor meetings and reports.
- Organize, attend and participate in internal team meetings.
- Prepare and/or edit meeting minutes, presentations and tables.
- Research and prepare training material, original publications/ posters and didactic presentations.
- Provide comprehensive review of rater data submitted from assigned studies.
- Monitor and report on rater progress throughout study lifetime.
- Track and report all task progress and time on task.
- Willingness to collaborate with other departments on various administrative tasks and projects.
- Responsible for appropriate time management including prompt completion and submission of individual project duties.
- Support Quality Assurance during external client audits.
- Responsible for any other duties delegated by the immediate manager or department lead.