Clinical Support Specialist - Operations

The Clinical Support Specialist in the Digital Health Sciences (DHS) team provides administrative support to the Clinical Lead on a project. The Clinical Support Specialist is responsible for the following tasks directed by the Clinical Lead for the project: rater processing, rater remediation, updating of quality management trackers in endpoint reliability programs, data edit flag reviews, Learning Management System (LMS) quality control. The Clinical Support Specialist is also responsible for communication related to these tasks with the GPM team and the Clinical Lead on the project. The Clinical Lead on the project provides direction and oversight of administrative tasks.

Key Accountabilities

• Demonstrate understanding of Qualification Methodology in all studies in which the Clinical Support Associate conducts rater processing.
• Work with the Clinical Lead on a project on developing clear guidelines for clinical recommendations for questionable raters.
• Conduct rater processing according to the Qualification Methodology with proficiency and accuracy
• Perform quality control on rater processing and provide documentation.
• Support Clinical Lead on a project on developing a remediation template for rater remediations on scoring component.
• Support Clinical Lead on updating the Endpoint Reliability trackers so that they are prepared for clinical analysis.
• Conduct selected data edit flag reviews in Endpoint Reliability programs under the supervision of the Clinical Lead on the study.
• Provide quality control to the training courses on Signant Health Learning management system and summarize findings.
• Engage in effective communication with raters, GPM team members and Clinical Lead on the study.
• Other responsibilities will be assigned as required.
  
  

DECISION MAKING AND INFLUENCE

• Facilitates and maintains team and company culture of collegiality, respect, and professional support.
• Considers all products and services in the context of providing the clinical trial study participant with an optimal clinical trial participation experience.
• Likewise considers all products and services in the context of the clinical trial research study sites.
• Maintains Signant Health as highly regarded for scientific expertise and industry leadership.
  
  

Knowledge, Skills & Attributes

Essential:

• Minimum bachelor’s degree with 2 years’ work experience.
• Proven ability to multitasking, time management and task-oriented performance; able to work in a fast-paced environment.
• Business driven and business growth savvy.
• Comfortable learning new roles and developing expertise in new fields through research and networking.
• Proven ability to be an effective, positive team player who can work across teams and in a matrix environment.
• Strong interpersonal and communication skills; ability to understand and communicate with stakeholders from a range of disciplines.
• Ability to develop expertise in new fields through ongoing education, research and networking. Excellent knowledge of spoken and written English.
  
  

Desirable:

• Prior experience in the healthcare industry or clinical research, preferably in more than one therapeutic area or indication (cardiology, oncology, psychiatry, or psychology, etc).
• Good understanding of clinical research and the drug development cycle.
• Can easily communicate with clients and all levels within the organization.
• Prior experiencewith patient-reported outcome measures (PROs) or Clinical Outcome Assessments (COAs)
  
  

At Signant Health, accepting difference isn’t enough—we celebrate it, we support it, and we nurture it for the benefit of our team members, our clients and our community. Signant Health is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or veteran status.