Senior Clinical Associate
Bracket - Wayne, PA

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The Senior Clinical Associate participates in applicable aspects of projects, including data analysis and reporting for cognition activities, rater training, and data surveillance tasks.

Essential Duties and Responsibilities: Other duties may be assigned.

Clinical Responsibilities

Develops project specific video material:
• Screens patients for appropriate disease indication and current symptoms
• Coordinates patient scheduling
• Facilitates the patient consent and reimbursement process
• Conducts patient interviews and/or provides clinical feedback on interviews as appropriate
• Assists with editing of project specific video material

Develops clinical content for rater training and qualification programs for study staff in clinical trials:
• Prepares initial drafts of project specific didactic presentations
• Identifies protocol specific instruments and their appropriate means of procurement
• Participates in acquisition of protocol specific instruments as appropriate
• Drafts initial certification methodology and revised methodology based on sponsor feedback and/or modifications to the protocol

Communicates with study site staff to address data quality issues:
• Communicates with study site staff in accordance with project specific methodology/SOPs
• Develops templates for communication with study site staff
• Documents communication with study site staff in the respective IT application (e.g., RDA, IR2)

Ensures compliance with quality assurance as outlined in SOPs/Clinical Operations Guidelines:
• Reviews and documents rater experience status and/or provides second review for quality assurance
• Provides review of clinical deliverables (e.g., web based training, educational CD-ROMs, Meeting Highlights CD-ROMs, etc.)

Participates in reporting and analysis activities:
• Assists with study component design
• Develops reporting and analysis plans as appropriate
• Facilitates interaction with other department staff supporting cognition projects to ensure data flow, data processing and review is conducted appropriately
• Collaborates with designated supervising clinician on the overall interpretation of the results and the discussion and conclusions sections of outgoing reports
• Revises report based on sponsor feedback
• Communicates with sponsors as appropriate

Conducts remote scoring, interview assessment, and/or central rating:
• Conducts/reviews protocol specific scale interviews with patients (may require flexible schedule to accommodate time zone variations)
• Completes all required documentation within specified timeframe

Procures external Clinical Experts based on documented requests from Project Management:
• Utilizes and maintains database of availability and scheduled attendance at Investigators’ Meetings
• Serves as liaison to external Clinical Experts (e.g., establishes initial contact, appropriately refers identified issues)


Participates in research activities:
• Collects and disseminates needed literature and/or data to support clinical research, and business development endeavors
• Assists with development of research design and associated materials


Prepares reports of clinical activity:
• Submits weekly report of activity to manager
• Tracks clinical metrics and provides to supervisor for reporting
• Participates in orientation and training of staff as appropriate
• Enhances the UBC Specialty Clinical Services business model by institutionalizing business processes, implementing best practices, templates, and seeking ways to work more efficiently
• Ability to perform all responsibilities of Clinical Associate if required

Skills & Competencies

• Minimum of Bachelor’s Degree in psychology or life sciences field or RN

• 1 year clinical experience with psychiatric and/or cognitive rating scales OR one year as successful Clinical Associate at UBC

Personal Attributes
• Scientific writing skills
• Competency working with data and numbers
• Familiarity with computers, in particular, Microsoft Office Suite
• Familiarity with office equipment (printers, copiers)
• Excellent communication skills
• Ability to succeed in a fast-paced, entrepreneurial environment
• Successfully manages own time, proactively identifies and prioritizes multiple tasks
• Fluency in English (will be required to write, speak and understand English to conduct day-to-day business)
• Willingness to travel
• Willingness to maintain flexible schedule

We offer a highly competitive base salary and an outstanding benefits program, including medical, prescription drug, dental, vision, 401(k) with Company match, life insurance, and generous paid time off.
We are an Equal Opportunity Employer, M/F/D/V

About this company
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Founded in 2011, Bracket is the union of United BioSource Corporation's (UBC) Specialty Clinical Services and Clinical Technologies...