Job Description
Job Summary:
- The Research Scientist I is responsible for coordinating and facilitating the life cycle of investigator-initiated research projects.
- This includes the development of design, initiation, conduction, analysis, and publication of clinical research projects of both a retrospective and prospective nature.
- The Research Scientist I simultaneously manages multiple projects at varying stages throughout the study process.
Duties & Responsibilities:
- 10% Statistical Analysis:
- Works independently or in collaboration to identify proper statistical techniques for analysis of all study-related data.
- Performs or works collaboratively to obtain statistical analyses and provides proper interpretation of results.
- Helps investigators and clinical staff to understand the impact of results on patient care
15% Medical/Technical Writing:
- Responsible for collaborative writing of grant portions, study concepts and related documents, peer-reviewed publications, academic posters and associated abstracts, and other documents on behalf of and in collaboration with study investigators.
15% Regulatory Duties:
- Uses effective critical thinking and problem solving in the submission and maintenance of investigator-initiated projects to the institutional IRB to ensure compliance with institution and federal guidelines, and regulations.
- Provides timely and accurate submission of all IRB and additional regulatory materials as required by collaborating organizations, or the federal government.
- Stays up to date with applicable institutional, federal and state regulations.
20% Research Project Design:
- Works collaboratively with physicians, colleagues, and/or other professionals to discuss process ideas and design the most effective research projects.
- Develops specific study aims and hypotheses, creates study tools (i.e. surveys, forms), ensures compilation of complete list of study variables, and writes study protocols.
- Serves as a liaison with department administration/clinical staff and RAO.
- Ability to understand protocol designs.
25% Study Conduct:
- Ensures completion of study activities per protocol including, but not limited to: recruitment, ascertaining pretreatment and eligibility requirements; obtaining informed consent; registering participants; interviewing and obtaining medical and social histories; collecting data from medical records; administering, scheduling and/or scoring tests, as appropriate.
- Monitors study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices; assists with initiation, planning, execution, control and closure of investigator-initiated protocols.
5% Continuing Education:
- Participates in continuing education to maintain current knowledge of research processes, regulations, and other activities pertinent to position.
- Proactively participates in development and/or presentation of education events for internal peers and customers, as appropriate.
5% Quality Assurance:
- Maintains quality assurance activities to meet all regulatory, sponsor, and institutional expectations for compliance and best practice.
5% Special Projects:
- Involvement in the planning, management, and execution of projects outside of the typical role, as assigned.
Required Skills & Experience:
- Three plus (3) + years of relevant professional experience.
- Demonstrated ability in effectively managing data, statistical analysis and interpretation, medical and grant writing, and study design, as appropriate for department needs.
- Computer proficiency in word processing and Excel.
- Knowledge of medical terminology.
- Knowledge of principles of research and federal regulations.
- Excellent writing and editing skills.
- Strong organizational skills and be detail oriented.
- Ability to understand statistical and protocol design.
- Excellent leadership, interpersonal and oral, written and electronic interpersonal communication skills.
Preferred Skills:
- 3+ years of research scientist experience, hands-on experience with timely and accurate IRB and regulatory submissions, and proficiency in Word and Excel.
Required Education:
- Master’s degree in research, epidemiology, biostatistics, statistics, chemistry, or related field OR bachelor’s degree with 5+ years of relevant professional experience.