Clinical Specialist

Employees Create the Evidence that Matters

 

As demand for the rapid delivery of new pharmaceuticals, biotechnology and medical devices to identify, treat and prevent disease is on the rise, never has the need for conclusive evidence of product efficacy and effectiveness been greater. United BioSource Corporation is focused on meeting this growing demand for evidence.

UBC: a fast growing, full range, global pharmaceutical services organization.

Delivering evidence-based services and solutions depends on the quality and dedication of our staff. We seek the brightest, most talented professionals in the industry.

Whether you are launching a career or seeking new challenges, UBC fosters personal and professional growth on diverse and challenging projects amid highly respected scientific, clinical and data professionals, and offers a robust compensation and benefits package.

Come join our team to deliver the scientific evidence helping products succeed in the real world and saving millions of lives because Evidence Matters.

Position Overview:

Position Title: Clinical Specialist

Reports To: Clinical Manager (USA)

 

Position Overview: The Clinical Specialist participates in all aspects of clinical content development. Additionally, he or she ensures that the content is clinically accurate and that it adheres to the sponsor’s clinical criteria and particular study requirements. Clinical Specialists also are responsible for developing the parameters against which raters are judged, remediating raters who do not adequately satisfy those criteria, and providing documentation of this process and its results.

Essential Duties and Responsibilities: Other duties may be assigned. Prepares, evolving as appropriate, and maintains rater qualification methodology and documentation thereof. Develops high quality clinical content for rater qualification and medical education training programs including but not limited to the preparation of patient interview videos, presentations, and educational CD-ROMs. Video preparation includes interviewing patients, editing tapes and scoring videos. Develops acceptable score ranges for rating scale items and conducts analysis of rater performance based on score statistics and clinical judgment. Manages the questionable rater follow up process including updating the qualification methodology as necessary, recommending and implementing appropriate “remedial training” as per the qualification methodology, communicating questionable rater outcome to project specialist and team, reviewing updated rater qualification data and statistical analysis. Oversees the qualification process of new raters during the in-study period including updating qualification methodology as necessary, reviewing updated rater qualification data and statistics, and following up with questionable raters as per the qualification methodology. Successfully completes deliverables within the budgeted timeframe. Prepares interim and final study reports based on the collective input from the project team.

Masters Degree or above, MD., Ph.D., Psy.D, Pharm.D, in healthcare-related field; or Bachelor Degree with 5 years clinical trial experience; or RN with 10 years clinical trial experience. Three (3) years Clinical and/or clinical research experience in one of the areas of psychiatry, neurology, or other related therapeutic areas; OR two (2) years clinical and or clinical research experience and one (1) year as successful Clinical Associate at UBC TEG. (Clinical experience is defined as direct patient experience providing treatment, care of diagnostic evaluations; clinical research experience is defined as the direct administration to patients of research instruments such as diagnostic rating scales.)

Knowledge Excellent writing skills. Familiarity with psychiatric nomenclature (DSM/ICD). Demonstrated strong analytical, organization, creative problem solving and communication skills (both internal and external) with all levels of personnel. Ability to succeed in a fast-paced, entrepreneurial environment. Basic knowledge of statistics.

Skills Competency with conducting patient interviews. Comfortable with videotaping scale administration with patients, education videos, etc. Good negotiation and diplomacy skills. Ability to manage own time, proactively identify what needs to get done and prioritize multiple tasks. Ability to work with all levels of staff and disciplines. Good computer skills in particular, Microsoft Office Suite. Fluency in English (will be required to write, speak and understand English to conduct day-to-day business) Detail oriented. Willingness to travel.