- Conduct literature searches, primarily focusing on fluid, imaging, or clinical outcomes with proven ability to evaluate and interpret data
- Review articles, abstracts, and analyses
- Summarize data into Excel sheets, tables, or graphs
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- Create presentations outlining search topic strategies and detailing how keyword searches were conducted
- Evaluate the strength of data sets and provide recommendations to leadership
- Prepare concise descriptions of operating characteristics for clinical outcomeDevelop short procedures for assays or the operational conduct of clinical tests
- Assist, proofread, and elaborate on specific sections across various clinical documents, including Phase I/II protocols, IND preparations, trial designs, and manuals of operations
- External facing communication with sites or CROs may be required
- Prepare slides for both internal and external communication of clinical development plans
- Develop trial schema for Phase I and II trials, Gantt charts for trial data milestones, and figures for outcomes
- Convert figures, tables, and graphs for trial documents
- Proficiency in clinical trials and epidemiology statistics is essential
- Ability to perform basic sample size calculations is desirable
- At a minimum, possess enough familiarity to provide necessary data to a CRO Stat group for tasks such as sample size calculations, time-to-event analysis, or sensitivity analysis
- Engage in sponsor-side clinical trial management, including activation and implementation
- Collaborate with CROs to ensure oversight, quality, and timely delivery of trial objectives
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Clinical Research Associate II, Clinical Development - Cambridge, United States - Kisbee Therapeutics
Description
COMPANY OVERVIEWKisbee Therapeutics is an early-stage, venture-backed biotech startup that is targeting apolipoproteins to develop novel therapeutic agents for neurodegenerative diseases. Our mission is to translate genetic and biochemical insights into therapies that promote brain health and repair. This is a fantastic career opportunity within an early-stage company dedicated to advancing disruptive and ground-breaking technology with the promise to change the course of neurodegenerative disease for millions of patients.
POSITION SUMMARY
In pursuit of excellence, we eagerly invite a motivated and creative Clinical Research Associate II, Clinical Development to join our Research and Development team. This position will have the opportunity to conduct research in early phase clinical development (translation from the biology group to first-in-human phase I trials. This opportunity involves the effective use of your scientific rigor for understanding the fundamentals of experimental design in analyzing literature and data to support clinical development plans. The individual will have the opportunity to grow their career through development and refinement of analysis and presentation skills under the mentorship of our experienced team. If you're passionate about Clinical Development A-Z, we encourage you to apply Don't worry if you don't meet all the requirements listed, we are committed to helping you grow and succeed
KEY RESPONSIBILITIES
Research and Data Review Preparation:
Preferred MA/MS/MPH in neuroscience, psychology or medical epidemiology and 2+ years of independent application of key responsibilities or a BA/BS and 4+ years of relevant (academic
or industry) experience in pharma/biotech phase I clinical development and clinical translation from biology to clinical trial with preferred areas of study: neuroscience, psychology, medical epidemiology. (please apply if you feel you are qualified even if you don't have the preferred experience and qualifications)
BENEFITS
All eligible employees receive a generous package that includes: compensation, discretionary bonus, incentive stock options, the opportunity to participate in the Company's health, dental, vision and 401k plans, life and disability insurance benefits, non-accrual paid time off, company holidays and winter company shut down We embrace diversity and do not discriminate based on race, religion, color, national origin, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. Reasonable accommodations will be provided for individuals with disabilities during the application process, interviews, and while performing essential job functions. Contact Human Resources for accommodation requests.
RECRUITMENT
The Human Resources department oversees all recruitment and employment activities for Kisbee. Please note that unsolicited resumes sent to Kisbee by recruiters do not establish any form of relationship between the recruiter/recruiting agency and Kisbee. Submission of unsolicited resumes also does not impose any obligation on Kisbee to pay fees should we choose to hire from those resumes.
We kindly request that external recruiters/agencies refrain from contacting or directly presenting candidates to our hiring manager or employees.
