Clinician, Scientific Affairs & Clinical Assessment
Worldwide Clinical Trials - King of Prussia, PA

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SUMMARY:
The Clinician is responsible for all aspects of assigned projects that include clinical assessment, training development and data review for Worldwide Clinical Trials, Inc. (WCT). The Clinician works under the direction of the Director, Scientific Affairs and Clinical Assessment.

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

The Clinician must apply a working knowledge of clinical assessments to the development of training materials

The Clinician is responsible for reviewing study specific assessment-related data, as defined in the training plan, to determine eligibility of subjects and contact sites for clarification of data as well as results of the reviews

The Clinician is responsible for tracking the data reviews and monthly reporting to the sponsor and study team

The Clinician is responsible for reviewing rater data to determine if rater or data errors have occurred, tracking, reporting and reconciling the data errors

The Clinician must have experience with clinical research and the utilization of clinical assessment measures

ESSENTIAL TASKS AND EXPECTED RESULTS:
Development and management of training plans, data review plans, schedules, and timelines

Development and oversight of data review and dissemination of data review

Research into scale acquisition and coordination with WCT and the sponsor to acquire licenses

Research and contact content experts to coordinate with the Manager, Scientific Affairs

Development of Training materials under the guidance of the Director, Scientific Affairs

Development and review of presentations for adherence to template design and consistency

Conducts remote scoring/assessment 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 establishment of score ranges

Reviews and provides feedback on protocol/CRF

Approves and ensures quality of clinical content

Attends regular client meetings, and attends Investigators’ Meetings to assist with direct 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 QCs final reports, white papers and other scientific text

Participates in training and/or ongoing synchronization of external Clinical Experts

Conducts training for WCT 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.

OTHER SKILLS AND ABILITIES:
Well organized and management skills are essential attributes

Clear understanding of best business practices with respect to rater training, methodologies, and corporate discipline

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

Excellent written and verbal communication skills to clearly and concisely present information

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

Excellent ability to handle multiple tasks and many administrative details in a fast-paced and constantly changing environment

Ability to exercise sound judgment and make decisions independently

Excellent self-motivation skills

Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint

REQUIREMENTS:
Minimum of earned Master’s Degree, M.D., Ph.D., PsyD, Pharm.D., in healthcare-related field, with one year of clinical experience, which includes administration of psychiatric and/or cognitive scales OR RN with 3 years of clinical experience, which includes administration of psychiatric and/or cognitive scales

Previous experience managing team members

Demonstrable knowledge of operational aspects Phase I-IV clinical research and experience working with a Contract Research Organization/Rater Training Organization

The ideal candidate should also have experience in a start up situation and building or implementing databases, project plans, as well as standardized processes and procedures

The successful candidate must be detail- and service-oriented, and able to work under pressure

He/she must possess excellent writing and oral 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 highly effective internal and external relationships through personal influence

  • Demonstrated strong analytical, organizational, creative problem solving and communication skills Ability to succeed in a fast-paced, entrepreneurial environment
Basic knowledge of statistics

Competency conducting patient interviews

Comfortable with being videotaped

Competency working with data and numbers

Good negotiation and diplomacy skills

Successfully manages own time, proactively identifies and prioritizes multiple tasks

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

Fluency in English (will be required to write, speak and understand English to conduct day-to-day business)

Detail oriented

Willingness to travel

Willingness to maintain flexible schedule

Required Skills

Required Experience

Worldwide Clinical Trials - 19 months ago - save job - block
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About Worldwide Clinical Trials Worldwide Clinical Trials is a global CRO providing full-service drug development services to the...