What are the responsibilities and job description for the Scientist 3 - Clinical Research position at eTeam Inc?
Pay Rate : $55 - $61 / Hour
Overview :
Responsible for the translation and implementation of (non-medical) scientific concepts into the study design and / or program across planning, execution, and reporting, including integration of biomarkers, digital technologies, data science initiatives, and select vendors
Job Responsibilities :
Program / Trial Planning, Execution and Reporting
- Responsible for leading the translation of scientific concepts into program and study design
- Responsible for identifying and implementing (non-medical) scientific aspects of the program and / or study at planning, execution and reporting, including (but not limited to) integration of Biomarkers and Data Science / Digital Health initiatives into studies.
- Oversees the assessment, selection and operational implementation for biomarkers, digital and other endpoints (scales), imaging
- Accountable for shaping and implementing compound and program DEI strategy together with Clinical Leader
- Provides expert input in clinical development plans
- Contributes to the preparation of PED, study protocols and training materials for clinical studies.
- Prepares for and participates in Protocol review Committee (PRC) and First in Human (FIH) Committee meetings
- Reviews medical and scientific literature
- Along with SRP or Clinical Leader and global development partners, responsible for oversight and high-quality implementation and closure of the study, ensuring data integrity
- Responsible for the TA review and sign off on various operational plans
- Responsible for scientific input into HA and EC responses.
- In concert with operational staff, acts as a liaison between the company and clinical investigators for overarching scientific guidance and other potential non-medical aspects
- Works closely with Data Sciences, Data Management, Statistics, Programming, JJIT and others to ensure data are received in the manner needed to support trial outcomes
- Responsible for the review of the data to ensure quality and to identify data quality trends.
- Sets up and leads Adjudication Activities
- Leads data visualization (DV) meetings and ensures decisions are documented and communicated internally and externally
- Owns contracting with clinical consultants, IDMC members and KOLs, including payment oversight.
- Participates in vendor oversight focusing on the integration of data and technology in clinical trials
- Contributes to completion of clinical study reports
- Contributes to the interpretation, reporting and preparation of oral and written results of product research in concert with senior clinical personal, in preparation for health authority submissions.
Additional Clinical Research Responsibilities
May act, in concert with senior clinical personnel, as the company spokesperson regarding publication of clinical research findings. This may include presenting research results at internal / external meetings (i.e. investigator meetings and company sponsored events).
PhD in relevant field (e.g. Neuroscience, Biomedical Sciences, Biology; chemistry : pharmacy) , PharmD or MD degree from an accredited institution with 1-2 yrs work experience; or Masters in relevant field with 2-4 yrs work experience
Salary : $55 - $61
