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Clinical Associate

Bracket

Science. Technology. Service.

Bracket innovates at the leading-edge of clinical research data, one exceptional service at a time. From the advanced technology of our eCOA electronic Clinical Outcomes Assessments flexible platform, to the efficiency of our scalable and configurable Randomization and Trial Supply Management (RTSM) Clinical IRT solution, to our science-focused Rater Training and Quality Assurance programs, Bracket does it faster, better and with an eye on the future of our industry. To achieve this, we maintain an unwavering commitment to employing only the brightest, most talented colleagues gleaned from a wide variety of professional fields.  If you are a creative problem-solver and have a hard-wired, instinctual commitment to exceptional customer service, we'd love to talk to you!

Position Overview:

The Clinical Associate participates in applicable aspects of clinical content development and delivery, which may include training material development and QC, data review, eCOA user acceptance testing, study staff contact, sponsor contact, contact with outside experts, and report writing.  The Clinical Associate also has responsibility for maintenance and classification of clinical information/materials.

Essential Duties and Responsibilities: Other duties may be assigned.

Clinical Responsibilities

Develops project specific training material:

Prepares initial drafts of project specific clinical deliverables (e.g., didactic presentations, certification methodology, protocol and CRF reviews)
Assist with eCOA development and testing, including draft writing of alerts, notifications and scripts and UAT testing
Assists with  acquisition and review of protocol specific instruments as appropriate
Video development
Screens patients for appropriate disease indication and current symptoms, as appropriate
Coordinates patient scheduling
Facilitates the patient consent and reimbursement process
Provides clinical feedback on interviews as appropriate, if appropriate
Ensures project appropriate interview materials are present at video shoot

Participates in project specific processes related to rater training and endpoint reliability:

Completes review of rater experience to determine qualification status of rater prior to start of study

Crafts and sends tutorials to raters requiring remediation
Communicates with study site staff in accordance with project specific methodology/SOPs as appropriate
Drafts templates for communication with study site staff
Documents communication with study site staff in the respective IT application (e.g., RDA, Rater Station)

Utilizes Rater Station platform or other platforms and spreadsheets to schedule clinical contact calls between Site/PI/Rater and Bracket Clinician/NLE

Performs data quality reviews under the supervision of Clinical Scientist:

As part of Bracket’s Endpoint Reliability programs reviews scale worksheets or data points using guidance methodologies and identifies data points that may be discrepant

Ensures compliance with quality assurance as outlined in SOPs/Clinical Operations Guidelines:

Reviews and documents rater status and/or provides second review for quality assurance
Provides review of clinical deliverables (e.g., web based training, videos, methodology documents, paper scales, eCOA scales, etc.) under the supervision of the project clinician

Participates in reporting and analysis activities under direct supervision:

Assists with study component design
Develops draft of report summarizing project specific clinical activity as appropriate
Conducts data quality reviews as requested
Conducts QC of report components as appropriate (e.g., graphs)

Research

Participates in research activities:

Collects and disseminates needed literature and/or data to support clinical research, and business development endeavors

Administration

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 Bracket business model by institutionalizing business processes, implementing best practices, templates, and seeking ways to work more efficiently

Skills & Competencies

Education

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

Experience

1 year clinical experience with psychiatric and/or cognitive rating scales

Personal Attributes

Scientific writing skills
Competency working with data and numbers
Familiarity with computers, in particular, Microsoft Office Suite (Excel, PowerPoint)
Competency working in custom data bases and excel reporting
Familiarity with office equipment (printers, copiers)
Excellent communication skills, oral and written
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 maintain flexible schedule

We offer a fully comprehensive benefits program with medical, dental, vision, company paid life insurance, short and long term disability.  Great Paid Time Off program that starts with 20 days of accrual per calendar year; great 401k plan with company match that is 100% vested immediately.  Paid parental leave and other competitive benefit programs.  Great salary and reward and recognition programs. 

EEO Minorities/Women/Veterans/Disabled

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