Clinician Rater, Contractor

What the Clinician Rater does at Worldwide Clinical Trials

The Clinician Rater is responsible for all aspects of assigned projects, including clinical assessment, training development, and data review for Worldwide Clinical Trials, Inc. (Worldwide). The Clinician works under the direction of the Director, Clinical Assessment Technologies (CAT).

What you will do

• The Clinician is responsible for the clinical aspects of CAT projects as assigned

• Applies a working knowledge of clinical assessments to the development of training materials

• Reviews study-specific assessment-related data, as defined in the training plan, to determine subject eligibility and contacts sites for data clarification and review outcomes

• Tracks data reviews and provides monthly reporting to the sponsor and study team

• Reviews rater data to identify rater or data errors and is responsible for tracking, reporting, and reconciling errors

• Demonstrates experience with clinical research and the utilization of clinical assessment measures

• Develops and manages training plans, data review plans, schedules, and timelines

• Develops and oversees data review activities and dissemination of data review findings

• Conducts research into scale acquisition and coordinates with Worldwide and sponsors to obtain licenses

• Assists in the review of electronic Clinical Outcome Assessment (eCOA) and electronic Patient-Reported Outcome (ePRO) specifications and participates in User Acceptance Testing of equipment and programs

• Researches and contacts content experts to coordinate trainings

• Develops training materials under the guidance of the Director of Clinical Projects, CAT

• Develops and reviews presentations for adherence to template design and consistency

• Conducts remote scoring and assessments as appropriate

• Communicates with study site staff regarding data quality issues

• Prepares drafts of clinical content for training and qualification programs in clinical trials and reviews clinical deliverables as appropriate

• Contributes to research efforts

• Conducts patient interviews, prepares scoring rationale, and coordinates the establishment of score ranges

• Reviews and provides feedback on protocols and Case Report Forms (CRFs)

• Approves and ensures the quality of clinical content

• Attends regular client meetings and Investigators’ Meetings to assist with the execution of training as appropriate

• Travels to sites for motivational visits and monitoring of clinical assessments as appropriate

• Collaborates internally and externally to ensure appropriate study design

• Writes and performs quality control reviews of final reports, white papers, and other scientific texts

• Participates in training and ongoing synchronization of external Clinical Experts

• Conducts training for Worldwide staff and investigators as appropriate

Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

What you will bring to the role

• Strong organizational and management skills

• Clear understanding of best business practices related to rater training, methodologies, and corporate discipline

• Strong planning, strategizing, managing, monitoring, scheduling, and critiquing skills

• Excellent written and verbal communication skills

• Strong interpersonal skills in a fast-paced, deadline-oriented, and changing environment

• Excellent ability to manage multiple tasks and administrative details in a constantly changing environment

• Ability to exercise sound judgment and make decisions independently

• Strong self-motivation skills

• Proficiency in Microsoft Office applications, including Word, Excel, and PowerPoint

Your experience

• Master’s degree, M.D., Ph.D., PsyD, or Pharm.D. in a healthcare-related field with one year of clinical experience, including administration of psychiatric and/or cognitive scales, or a Bachelor’s degree in a healthcare-related field or Registered Nurse (RN)

• A minimum of three (3) years of clinical experience, including administration of psychiatric and/or cognitive scales

• Minimum of five (5) years of experience working at clinical sites, which may include Contract Research Organizations (CROs), rater training organizations, clinical trial sites, or biotechnology-related industries

• Demonstrable knowledge of operational aspects of Phase I–IV clinical research and experience working with a Contract Research Organization or rater training organization

• Experience in startup environments and building or implementing databases, project plans, and standardized processes and procedures

• Detail-oriented and service-oriented with the ability to work under pressure

• Excellent written and verbal communication skills and advanced Microsoft Excel skills

• Demonstrated ability to establish, monitor, and work within budget parameters

• Excellent ability to work in teams

• Demonstrated ability to establish and maintain effective internal and external relationships

• Strong analytical, organizational, creative problem-solving, and communication skills

• Ability to succeed in a fast-paced, entrepreneurial environment

• Competency in conducting patient interviews

• Knowledge of Clinician-Reported Outcomes and Patient-Reported Outcomes across multiple indications

• Knowledge of placebo response mitigation through various training techniques

• Ability to research new measures across indications and develop appropriate training materials

• Comfort using innovative technologies to enhance training programs, including training video development, eCOA and ePRO technologies, and actigraphy

• Comfort with video and audio recording

• Competency working with data and numbers

• Strong negotiation and diplomacy skills

• Ability to manage time effectively and prioritize multiple tasks

• Ability to work with staff at all levels and across various disciplines

• Fluency in English, including the ability to read, write, speak, and understand English for day-to-day business

• Strong attention to detail

• Willingness to travel

• Willingness to maintain a flexible schedule

Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.